|Year : 2021 | Volume
| Issue : 3 | Page : 120-127
Evaluation of two conservative different treatment protocols for symptomatic proximal deep caries management in molar teeth; an 18-month clinical report
I Anand Sherwood1, B Divyameena2, T Ramyadharshini1, V Subashri1, Avijit Banerjee3
1 Department of Conservative Dentistry and Endodontics, CSI College of Dental Sciences, Madurai, Tamil Nadu, India
2 Vinayaka Mission's Sankarachariyar Dental College, Vinayaka Mission's Research Foundation (Deemed to be University), Salem, Tamil Nadu, India
3 Conservative and MI Dentistry, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, UK
|Date of Submission||25-Mar-2021|
|Date of Decision||28-Jun-2021|
|Date of Acceptance||12-Aug-2021|
|Date of Web Publication||30-Sep-2021|
Prof. Dr. I Anand Sherwood
Department of Conservative Dentistry and Endodontics, CSI College of Dental Sciences, 129, East Veli Street, Madurai, Tamil Nadu
Source of Support: None, Conflict of Interest: None
Aim: The primary aim of this clinical trial was to observe the clinical success in conservative management of symptomatic deep proximal caries in permanent molar teeth with two treatment pulpotomy with Biodentine and indirect pulp capping with calcium hydroxide.
Materials and Methods: A total of 71 patients who reported to department for the management of symptomatic proximal deep carious lesions in molar teeth participated in the trial. Posttreatment clinical success at 18 months was defined as asymptomatic teeth positively responding to cold pulp sensibility test (only in indirect pulp capping) and absence of periapical infection. Chi-squared test and Kaplan–Meier survival analysis were done.
Results: Chi-squared test revealed no significant association between pulp status and posttreatment follow-up in both the treatment groups. Kaplan–Meier survival analysis showed mean survival of pulpotomy procedure for moderate and ambiguous pulp as 66.16 and 67.77 weeks, respectively, with no significant difference for two different pulp statuses. In indirect pulp capping procedure, there was significant difference (P = 0.038) (Log-rank Mantel-Cox) between the two pulp status category with moderate pulpitis having mean survival period of 69.27 weeks and ambiguous pulp with 42.83 weeks.
Conclusion: Pulpotomy with Biodentine yielded better results than compared to indirect pulp capping.
Keywords: Calcium hydroxide, coronal pulpotomy, deep carious lesion, indirect pulp capping, partial caries excavation
|How to cite this article:|
Sherwood I A, Divyameena B, Ramyadharshini T, Subashri V, Banerjee A. Evaluation of two conservative different treatment protocols for symptomatic proximal deep caries management in molar teeth; an 18-month clinical report. Endodontology 2021;33:120-7
|How to cite this URL:|
Sherwood I A, Divyameena B, Ramyadharshini T, Subashri V, Banerjee A. Evaluation of two conservative different treatment protocols for symptomatic proximal deep caries management in molar teeth; an 18-month clinical report. Endodontology [serial online] 2021 [cited 2021 Dec 1];33:120-7. Available from: https://www.endodontologyonweb.org/text.asp?2021/33/3/120/327271
| Introduction|| |
Dental caries is the most common preventable chronic condition of the people worldwide.,, Conservative management of the deep carious lesion has been shown to aid in pulp recovery. Traditional deep caries management involved extensive non-, selective complete removal of all carious dentin. The contemporary minimally invasive treatment strategy is based on biologically selective carious tissue removal to reduce pulp exposure. This approach has been associated with effective management of the reversible pulp injury resulting from deep carious lesions. Clinically distinguishing reversible and irreversible pulpitis is still a challenge, and most of the present diagnostic methods do not present an accurate histological status of the pulp., Wolters et al., 2017 coined a term “Endolight,” suggested as a less invasive treatment approach for deep caries lesions with pulpitis symptoms. In their work, they suggested a revised clinical criteria for assessing the irreversible pulpitis. The rationale for his suggestion was based on histological findings by Ricucci et al., 2014 that even in cases with irreversible pulpitis, the inflammatory changes were confined only to the coronal portion, while the radicular pulp was viable. Already an established fact that the dentin is a reservoir of bioactive molecules with potential for pulp regeneration and healing, begs some unique questions.,, One among the question that arises in this scenario for the management of deep caries lesion with symptoms/signs of reversible pulpitis is which should be utilized, is it the healing potential of dentin or the radicular pulp? Schwendicke and Stolpe, 2014 published a report on cost-effective analysis of direct pulp capping (DPC) versus root canal treatment (RCT) and concluded that DPC was more effective in young patients with occlusal caries and nonsymptomatic pulp. Indirect pulp capping with selective caries removal with or without pulp protection has been associated with promising clinical outcomes.,,, Recent reports on success of pulpotomy using bioactive calcium silicate cements add further complexity regarding which treatment option would be appropriate in the conservative management of deep carious lesions.,
Hence, with these diverse reports, the present investigation was carried out with the primary aim to observe the clinical success in conservative management of symptomatic deep proximal caries in permanent molar teeth with pulpitis status classified according to a modified Wolters et al., 2017 classification. The two treatment options exercised were pulpotomy with Biodentine and indirect pulp capping with calcium hydroxide. Null hypothesis for this study was that there would be no significant difference in the two different treatment outcomes with reference to the pulp status.
| Materials and Methods|| |
A total sample size of 65 restorations for the two treatment groups was calculated to be sufficient to detect the statistical difference using G*Power software version 188.8.131.52 (Universtät Kiel, Germany) with effect size of 0.5 and α error = 0.05. After obtaining institutional ethical committee approval (CSICDSR/IEC/0050/2018), the clinical trial was registered in clinical trial registry of India (CTRI/2019/04/018816). A total of 71 patients who reported to department of Conservative Dentistry for management of symptomatic proximal deep carious lesions in molar teeth participated in the trial. Informed written consent was obtained from patients or guardians when appropriate. Only one restoration per patient was carried out.
Inclusion and exclusion criteria are presented in [Table 1]. Preoperative symptom type and intensity were recorded. Teeth with periodontal treatment within the past 3 months, teeth with cracks, any variations in root morphology, teeth to be used as an abutment for any prosthesis, patients undertaking orthodontic treatment or needing orthodontic treatment, patients with dentin hypersensitivity or using desensitization treatment, patients with more than two deep carious lesions in the molars, patients with psychiatric disturbances, or any systemic conditions requiring pain relief medications were excluded in the study. With certain modifications to pulp status criteria recommended by Wolters et al., 2017, pulp conditions of the tooth were recorded as moderate or ambiguous pulpitis [Table 1]. Modifications were in the assessment of cold sensibility response and radiographic presentation. Clinical assessment included cold sensibility test (Endo-Frost, Colténe-Whaledent India Pvt. Ltd., Mumbai, India), palpation and percussion, and presence of signs of inflammation (pain, abscess, sinus tract, and abnormal mobility). All periapical radiograph (PA) assessments were done by an independent blinded experienced clinician. All the baseline and posttreatment recall PAs were taken in paralleling cone technique by a single operator (Densmart X-ray film holder; Universal X rays, New Delhi, India) with a PSP scanner (VistaScan Mini Plus; Durr Dental, Bietigheim-Bissingen, Germany). All the radiographs were taken with standardized exposure parameters (70 kvp, 8 mA, and 0.2 s) and necessary radiation protection precaution, namely lead apron and thyroid collar protection to the patients.
Six operators trained for caries excavation and pulpotomy procedures carried out the treatment. Calibration of caries excavation was assessed by the corresponding author to standardize the extent of carious dentin removal. Treatment procedures were randomly distributed among the six operators by picking of concealed lots written with individual operator name. In the initial phase of the clinical trial from June 2017 to December 2017, a total of 29 patients participated for the pulpotomy procedure. In the next phase from January 2018 to June 2018, a total of 40 patients were recruited for indirect pulp capping management. [Figure 1] shows the flowchart of treatment group distribution of the study.
Under local anesthesia (LA) and rubber dam isolation using a large round carbide bur in slow-speed handpiece with water coolant superficial soft carious dentin were removed. Then, with a high-speed air rotor diamond burs (BR 41, Dia-Burs, Mani Co, Tochigi, Japan), access preparation was done. Upon confirmation of active bleeding from the pulp chamber, coronal pulp tissue was amputated to the level of canal orifices (full pulpotomy) using a sharp spoon excavator (2 mm size, Hu-friedy, USA). Pulp chamber was irrigated using saline (NS 500 mL, Sodium chloride 0.9%, Fresenius Kabi, Mumbai, India Pvt., Ltd) and the hemostasis by compressing saline-soaked sterile cotton for 2 min. If the pulpal bleeding was not controlled within 2 min; the tooth was excluded from the study. After bleeding control, Biodentine™ (Septodont Healthcare India Pvt. Ltd., Raigad, India) was mixed according to manufacturers' instructions placed over the root canal orifices to a thickness of 2–3 mm. A PA was taken at this stage using a PSP scanner (VistaScan Mini Plus; Durr Dental, Bietigheim-Bissingen, Germany) to confirm the placement of Biodentine™ over the canal orifices and this was assigned as baseline radiograph. A glass-ionomer cement layer (GC Fuji II, GC India, Medak, India) was placed over the Biodentine™ after 3–4 m followed by a layered resin composite restoration (Charisma Smart, Kulzer GmbH, Germany).,, Occlusal interference was checked and adjusted accordingly. The resin composite restorations were finished and polished in the same appointment with Super snap (Shofu Inc., Tochigi, Japan) [Figure 2].
|Figure 2: Clinical photographs of the pulpotomy procedure (a) Preoperative image of mandibular molar tooth. (b) Coronal access preparation showing evidence of active pulpal bleeding. (c) Placement of Biodentine™ over the amputated root canal orifices after control of pulpal bleeding. (d) Glass ionomer lining placed over the Biodentine™. (e) Final composite restoration to seal the coronal access. (f) Pretreatment radiograph of mandibular first molar tooth. (g) Immediately post pulpotomy radiograph. (h) 18-month posttreatment radiograph with intact periapical region|
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Indirect pulp capping
Isolation was performed with rubber dam. No LA was administered at this stage. Using a standardized minimally invasive operative protocol,, superficial, soft infected dentine was initially excavated with a sharp spoon excavator (2 mm size, Hu-friedy, Chicago, USA) followed by a large round carbide bur in slow-speed handpiece with water coolant. Caries excavation was accomplished carefully not to expose the pulp with firm or hard discolored affected dentine left behind in the pulpal floor and axial walls., Peripheral caries was excavated until sound dentine was retained for better bonding procedures., If pulp exposure occurred, those teeth were excluded from the study. Patients were asked whether they experienced severe sensitivity or pain during the preparation, and if required, a local anesthetic was then administered. Setting calcium hydroxide (Dycal, Dentsply Sirona, NC, USA) of up to 1 mm thickness was placed over the pulpal and axial walls, followed by resin composite (Charisma Smart, Kulzer GmbH, Hanau, Germany) restoration. Occlusal adjustments were done accordingly followed by finishing and polishing of the restorations as in earlier group. Postrestorative PA was taken and recorded as baseline radiograph. Least remaining dentin thickness (RDT), periodontal ligament space (PDL), and lamina dura were assessed and scored (explained in the posttreatment assessment section) [Figure 3].
|Figure 3: Clinical photographs of the indirect pulp capping procedure (a) Preoperative image of mandibular molar tooth. (b) Soft discolored caries excavated leaving behind firm discolored dentin (c) Placement of Dycal liner over pulpal floor and axial walls. (d) Acid etching of the tooth structure. (e) Final composite restoration. (f) Prerestoration radiograph of mandibular first molar tooth. (g) Immediate postrestoration radiograph. (h) Three-month postrestoration tooth requiring root canal intervention|
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In both the groups, total etch adhesive protocol was followed in accordance to the manufacturers' instructions (Gluma Bond 5, Kulzer GmbH, Hanau, Germany). To ensure that the liner materials (Biodentine™ and glass ionomer cement/Dycal) are not disturbed, etchant gel (37% phosphoric acid, EAZ ETCH, Anabond Stedman Pharma, Chennai, India) was applied only to cavity walls. Enamel was etched for 30 s and dentin for 15 s. Followed by flushing with water spray, cavities were dried with sterilized cotton pellets while keeping the dentin moist. Gluma Bond 5 was applied to the etched surface and light cured (LED D, Woodpecker Medical Instrument Co., Ltd. Guilin, China) for 30 s. Resin composite material was placed in incremental manner and light cured for 40 s. Finishing and polishing of restorations were done as in pulpotomy restorations.
Patients were prescribed analgesics to be taken only on a need basis. 24 and 48 h postoperative pain assessment and analgesic requirement were inquired by an independent examiner over telephonic call, this was recorded as (i) no symptoms (ii) sensitivity (iii) pain (iv) tenderness or sensitivity upon mastication or stimulation. Any patients reporting continuous or nocturnal pain on immediate posttreatment observation were booked in for RCT and treatment was categorized as failure. Posttreatment 15 days and 3, 6, 12, and 18 month's clinical examination was done by an independent endodontist. Posttreatment examination was scheduled as close as possible to the study methodology, but for the purpose of data collection, any recall visit occurring within plus or minus 10% of the advocated time was considered as occurring at that time. Clinical examination involved patient symptom inquiry (same criteria established for immediate posttreatment assessment), percussion evaluation, and cold pulp sensibility test response for only indirect pulp capping teeth. Posttreatment PA was taken at 18-month recall period. In between the 18-month recall period, radiographs were repeated only for those patients who reported of continued discomfort or cold sensibility response in indirect pulp cases had negative response or teeth requiring RCT. PA assessment included measuring the least preoperative (baseline) RDT in millimeters (mm) with the VistaScan measuring software tool (Durr Dental, Bietigheim-Bissingen, Germany), PDL space, and lamina dura changes. PDL space assessment was scored as (i) intact in all the roots (ii) no widening beyond 1/4th of root apex of all or any one of the roots (iii) widening along the entire length of all or any one of roots. Lamina dura was examined and scored as (i) intact on all the roots (ii) loss of lamina dura beyond the 1/4th of all or any one of the roots (iii) complete loss of lamina dura over all or any one of the roots. RDT measurement was done only for the baseline PA. On clinical or radiographic assessment, if the restoration showed any fracture or loss of restoration and pulp and periapical status was stable, the restoration was repaired/replaced with the same materials used before and recorded. If there were any signs of irreversible pulpitis or necrotic pulp such as spontaneous continuous or nocturnal pain, severe tenderness to percussion or negative response to cold sensibility testing along with or without radiographic findings of widening of PDL space/lamina dura loss along the entire length of all or any of the roots, patients were recommended for RCT, the treatment procedure was recorded as failure. Treatment failure stage was recorded closest to the scheduled posttreatment recall visit.
Descriptive statistics described the pretreatment and treatment outcome variables. IBM SPSS Version 23.0 (IBM Corp, NY, USA) was used for Chi-squared test to detect the association between the pulp status, the treatment outcome in the two different treatment groups. Kaplan–Meier survival analysis was done to estimate the survival of the treatment procedure for 72 weeks (18 months) period.
| Results|| |
A total of 29 molar teeth (14 males and 15 females) with mean age 34.17 ± 12.76 years were managed by the pulpotomy procedure. In this treatment Phase 14 and 15, mandibular and maxillary molars were managed, respectively. Mean preoperative RDT in pulpotomy group was 0.90 ± 0.71 mm. 42 teeth (22 males and 20 females) were managed by indirect pulp capping, 25 and 17 mandibular and maxillary molars, respectively, with mean patient age 33 ± 10.93 years. Mean preoperative RDT in indirect pulp capping treatment was 0.70 ± 0.77 mm. [Table 2] shows the preoperative symptoms and pulp status distribution for both the treatment groups.
|Table 2: Distribution of preoperative symptoms and pulp status in both the treatment groups|
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18-month posttreatment results are depicted in [Table 3]. Overall, in both pulp status groups, the pulpotomy treatment had higher number of no intervention at 18-month posttreatment time than indirect pulp capping. In pulpotomy treatment Group 2 teeth (6.89%) required RCT, one maxillary molar with ambiguous pulp and immediate posttreatment pain after 24 h and another maxillary molar with moderate pulpitis required RCT because of continuous pain at 15-day posttreatment time period. In the indirect pulp capping, Group 7 teeth (16.66%) [Table 3] required RCT and 1 tooth was extracted. Three mandibular molar with moderate pulpitis required RCT, with two teeth at 3 months and one at 15-day posttreatment because of pain [Table 3]. In ambiguous pulpitis category 5 molar teeth failed, of this 4 molar teeth required RCT (2 maxillary and 2 mandibular molars) and one mandibular molar tooth was extracted at 15-day posttreatment time [Table 3]. One mandibular molar tooth required repeat restoration at 15 days postoperatively [Table 3].
|Table 3: Treatment follow-up distribution at 18-month period in both the treatment groups|
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Chi-squared test revealed no significant association between pulp status and posttreatment follow-up in both the pulpotomy and indirect pulp capping treatment groups. Kaplan–Meier survival analysis showed mean survival of pulpotomy procedure for moderate and ambiguous pulp as 66.16 and 67.77 weeks, respectively, with no significant difference for the two different pulp statuses. In indirect pulp capping procedure, there was significant difference (P = 0.038) (Log-rank Mantel-Cox) between the two pulp status category with moderate pulpitis having mean survival period of 69.27 weeks and ambiguous pulp with 42.83 weeks. [Figure 4] shows the Kaplan–Meier survival graphs for pulpotomy and indirect pulp capping for the two different pulp status.
|Figure 4: Kaplan–Meier survival graphs (a) Survival graph for pulpotomy treatment group. (b) Survival graph of indirect pulp capping|
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| Discussion|| |
In the present investigation, efficacy of two different management strategies for symptomatic proximal deep caries lesion in molar teeth was evaluated. Pulp status of the teeth included in the study was assessed using a modified Wolters et al., 2017 classification and only teeth with moderate pulpitis and ambiguous pulp were selected. Rationale for including only teeth with moderate pulpitis being this could be the last stage of reversible pulpitis before part of the pulp changing to irreversible inflammation and whether this has any influence on the treatment outcome. Furthermore, most of the patients in our institution report to restorative treatment for caries lesion only upon symptoms development which meant increased number of deep carious lesions with moderate pulpitis. Proximal restoration survival in posterior teeth has been associated lesser clinical success than compared to occlusal restorations. Therefore, in this study, only the proximal deep caries management was taken up to evaluate the efficacy of modern deep caries management strategy in this clinical scenario.
Deep caries management by indirect pulp capping has been reported by various authors with high clinical success rate, and one common factor is the uniform dentinal depth of carious lesion.,,, Whereas, the preoperative symptoms (both symptomatic and asymptomatic teeth), also the pulpal health status assessment is varied from using electric pulp tester, cold spray or air-water spray, or combinations of any of these two.,,, Additional literature search on bioactive calcium silicate cements based pulpotomy procedure for deep caries management shows that this procedure has been executed with success in teeth with or without carious pulp exposure in PA and also in teeth with clinical signs and symptoms of either reversible or irreversible pulpitis in addition to the above-mentioned confounding variables.,,,,, No clear evidence could be gathered from these reports what should be the appropriate treatment option in deep caries management with and without pulp exposure evident in PAs and signs/symptoms of reversible or irreversible pulpitis. In this setting of confounding evidence, this study was planned as a 12-month trial from June 2017 to June 2018, the first 6 months involved cases managed with pulpotomy and the next 6 months had indirect pulp capping procedure which resulted in discrepancy in sample sizes between two treatment groups. Knowledge gathered from this study has allowed us to take up a new clinical trial with random allocation of the teeth to treatment groups to avoid this bias to provide more in-depth information about conservative management of deep caries lesion.
Results of RDT in the present study reveal assessing the pulp status and deciding the management strategy based on depth of caries lesion could be erroneous as RDT in both the pulp status across the two different treatment groups were similar with negligible standard deviations. The present observation show that the molar teeth with proximal caries and symptomatic moderate pulpitis had higher clinical success with Biodentine™ pulpotomy procedure than indirect pulp capping with setting calcium hydroxide cement. This is in contrast to a study by Asgary et al., 2018 where it was concluded that both pulpotomy and indirect pulp capping procedures had similar favorable clinical outcome and was not influenced by the pulp status. However, in the study cited, both occlusal and proximal caries were managed and both symptomatic and asymptomatic teeth were included and pulp status categorization was different from the current study. Furthermore, the capping material used was different from the present investigation. However, better performance of pulpotomy procedure over indirect pulp capping in the present report is in accordance to Schwendicke and Stolpe, 2014 observation that pulp capping procedure is more suitable for nonsymptomatic pulp in occlusal exposure sites than proximal caries. Furthermore, pulpotomy having better clinical success in the prevailing study is in accordance to Wolters et al., 2017 suggested therapy of coronal pulpotomy for moderate pulpitis. One tooth required a repeat restoration in indirect pulp capping this could be because of lesser thickness of composite restorative material compared to pulpotomy restoration.
In the present trial, teeth with mild changes in root apex in PAs and possibly mild tenderness were also included in the management protocol. This was because an earlier report by Hashem et al., 2015 has shown that pulpal disease is confined to coronal pulp, with only inflammatory changes and vasodilatation in the periapical region. In agreement to this finding, the present results also justify that minor radiographic changes in root apex with mild tenderness need not always indicate total pulp necrosis or irreversible pulpitis. Two modifications included for this study in the Wolters et al., 2017 classification were in clearer cold sensibility test response of the tooth and in percussion, PAs assessment. These modifications allowed for better categorization of the tooth pulp status. Benefits with the use of calcium hydroxide cement as liner have been shown to be questionable, but a recent meta-analysis concludes that the evidence for this liner in deep carious lesions to be unnecessary is very low quality. Therefore, whether the inferior clinical performance of indirect pulp capping in the present study was because of the choice of liner material may not be a valid argument. Furthermore, studies with calcium hydroxide liner alone or in comparison with bioactive calcium silicate cements have shown similar treatment outcomes in deep caries lesion management.,, No significant benefit has been shown with usage of bioactive calcium silicate cements as liners in deep caries management.
Therefore, the conclusion of the present study of pulpotomy with Biodentine™ performing better in symptomatic deep proximal caries lesion management in molar teeth with moderate pulpitis (reversible pulpitis bordering toward irreversible pulpitis) needs to be researched further with randomized clinical trials and observed over a longer period of time. Further clinical trial is proceeding in the authors' department with randomized allotment for pulpotomy and indirect pulp capping management of proximal deep caries lesion in molar teeth with symptomatic moderate pulpitis to have better understanding of the most appropriate conservative treatment for these teeth.
| Conclusion|| |
Biodentine pulpotomy performed better in symptomatic deep proximal carious lesion for molar teeth with moderate pulpitis than compared to indirect pulp capping within the limitations of this study.
Authors would like to thank, Dr. Falk Schwendicke, Department of Operative and Preventive Dentistry, Charité - Universitätsmedizin Berlin, Aßmannshauser Str. 4-6, 14197 Berlin, Germany, for valuable inputs in design of the study and preparation of manuscript.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3]