| CTRI Number |
CTRI/2019/02/017665 [Registered on: 14/02/2019] Trial Registered Prospectively |
| Last Modified On: |
25/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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Study to compare the results of tooth coloured filling in decayed teeth after either preservation or superficial removal of tooth pulp. |
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Scientific Title of Study
|
Treatment outcome of composite restoration performed with either indirect pulp therapy or full pulpotomy in deep proximal carious lesion- A clinical study. |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rechithra R |
| Designation |
Junior Resident |
| Affiliation |
Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi |
| Address |
Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
8848997926 |
| Fax |
|
| Email |
drrechithra92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Centre for Dental Education and Research, All India Institute of Medical Sciences ,New Delhi |
| Address |
Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9540055001 |
| Fax |
|
| Email |
kumarvijay29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijay Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Centre for Dental Education and Research, All India Institute of Medical Sciences ,New Delhi |
| Address |
Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9540055001 |
| Fax |
|
| Email |
kumarvijay29@gmail.com |
|
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Source of Monetary or Material Support
|
| Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of medical Sciences, Ansari Nagar, New Delhi-110029, India |
|
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Primary Sponsor
|
| Name |
Centre for Dental Education and Research |
| Address |
Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rechithra R |
Centre for Dental Education and Research |
Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India
New Delhi
DELHI |
8848997926
drrechithra92@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research,All India Institute of Medical Sciences |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Composite restoration with full pulpotomy. |
The teeth will be examined clinically and radiographically.No 330 or no 245 diamond bur will be used to enter the pit next to the carious proximal surface. The bur will be positioned parallel with long axis of the tooth crown. The pulpal floor will be prepared to a depth of approximately 0.2 mm inside the Dentin enamel Junction (DEJ). The occlusal extension towards proximal surface will be prepared as conservatively as possible and the proximal ditch cut will be initiated with the bur held over DEJ. The gingival floor will be prepared flat with approximately 90 degree cavosurface margin. Gingival extension of proximal box will be kept as minimal as possible in an attempt to maintain sound enamel margin .All the carious dentin will be removed. The access to pulp chamber will be gained and de-roofing will be done using a round diamond bur operated at high speed under air water coolant. The coronal pulp tissue will be excised using a spoon excavator until the canal orifice. After bleeding arrests pellet moistened with 5.25% NaOCl will be applied for 10 minutes at the orifices for achieving haemostasis. Once the haemostasis is achieved, ProRoot MTA will be mixed according to manufacturer’s instructions and placed in a 3 mm layer above the pulp tissue using MAP system and gently packed using a condenser. Resin modified GIC (RM-GIC) powder and liquid will be mixed as per manufacturers recommendations. Thin layer RM-GIC will be placed over the condensed MTA and cured for 30 seconds. Tooth will be restored with posterior bulk fill composite resin as per standard restorative protocol at division of Conservative Dentistry and Endodontics. |
| Comparator Agent |
Composite restoration with indirect pulp therapy. |
The teeth will be examined clinically and radiographically.No 330 or no 245 diamond bur will be used to enter the pit next to the carious proximal surface. The bur will be positioned parallel with long axis of the tooth crown. The pulpal floor will be prepared to a depth of approximately 0.2 mm inside the Dentin enamel Junction (DEJ). The occlusal extension towards proximal surface will be prepared as conservatively as possible and the proximal ditch cut will be initiated with the bur held over DEJ. The gingival floor will be prepared flat with approximately 90 degree cavosurface margin. Gingival extension of proximal box will be kept as minimal as possible in an attempt to maintain sound enamel margin The softened, humid, yellow or light brown dentin that does not offer any resistance to the manual excavation will be removed. The one with darker colour and harder consistency, which appears as chips or scales, will be preserved. Dycal will be mixed as per manufacturer’s instruction and applied on the remaining affected dentin with a ball point instrument. Resin modified GIC (RM-GIC) powder and liquid will be mixed as per manufacturers recommendations. Thin layer RM-GIC liner will be applied to dentin above the capping material using a ball applicator and light cured for 30 seconds. Tooth will be restored with posterior bulk fill composite resin as per standard restorative protocol at division of Conservative Dentistry and Endodontics. |
|
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Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Proximal carious lesion on mandibular molars.
2. Lesions with remaining dentin thickness less than 1 mm as determined on bitewing radiographs.
3. Symptoms suggestive of reversible pulpitis.
4. Positive response to cold test.
5. Teeth with restorable carious lesions.
|
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| ExclusionCriteria |
| Details |
1. History of spontaneous sharp shooting pain suggestive of irreversible pulpitis.
2. Teeth with immature roots.
3. Teeth with sub gingival extension of proximal caries.
4. Teeth with cracks, cusp fractures, poor periodontal health.
5. Periapical pathology on an IOPA radiograph, presence of sinus tract or swelling.
6. Patients with systemic conditions which could compromise the healing.
7. Patients not willing to participate in the study.
Intra Operative Exclusion Criteria:
1. Teeth with direct pulp exposure during caries excavation.
2. Teeth in which haemostasis cannot be achieved within 10 minutes after complete pulpotomy.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Clinical success.
Absence of spontaneous pain and/or sensitivity to percussion and palpation, fistula / swelling, pathological mobility. Normal probing pocket depth and positive response to pulp vitality test.
2. Radiographic success.
Absence of increase in periodontal ligament space, radiolucency at the periapical region, internal root resorption or external root resorption. |
6 and 12 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Satisfactory functional and biological parameters of posterior class II composite resin restoration as per modified USPHS criteria. |
6 and 12 months |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
None yet. |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
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Dental amalgams have been the well documented, predictable, inexpensive and most widely used restorative material for over 150 years. However, they are declining in use in dentistry mainly due to their unesthetic appearance and concerns about their mercury content. The Minamata convention on mercury in 2013 has advised for the phase down of use of dental amalgam. Dental resin composites were developed to overcome the limitations of dental amalgam and response to people’s demand for an alternate tooth-coloured restoration.The current study compares the treatment outcome of composite restoration performed with either indirect pulp therapy or full pulpotomy in deep proximal carious lesion. This study is a two group parallel randomised controlled trial with a sample size of 60 patients. Preoperative clinical and radiographic assessment will be done and patients will be included based on inclusion and exclusion criterias. Block randomisation procedure / technique will be utilized to distribute subjects equally in to followings study groups 1. Group I : Indirect pulp therapy (using calcium hydroxide capping) 2. Group II : Full pulpotomy(using MTA as medicament) Teeth in both the groups will receive final restoration with composite resin. The subjects will be followed up at 6 and 12 months and teeth will be evaluated clinically and radiographically. The 12 month follow-up will be taken as endpoint for the study. Appropriate statistical test would be applied to the data generated. So far 50 patients have been enrolled and 6 months follow up has been completed for subjects recruited in the first 6 months. One year follow up will start in 3 months.
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