| CTRI Number |
CTRI/2019/05/019132 [Registered on: 15/05/2019] Trial Registered Prospectively |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Success of pulpotomy performed with or without a pulp capping material in teeth with deep cavity |
|
Scientific Title of Study
|
Outcome of full pulpotomy performed with or without calcium silicate based cement in mature permanent teeth with mechanical pulp exposure- a split mouth study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archana Aravind |
| Designation |
Junior resident |
| Affiliation |
AIIMS |
| Address |
Department of Conservative Dentistry and Endodontics, Centre for Dental Education and Research,AIIMS,
Ansari Nagar
South DELHI
New Delhi-110029
India
Centre for Dental Education and Research, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9947663992 |
| Fax |
|
| Email |
archna.arvind@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajay Logani |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Department of Conservative Dentistry and Endodontics, Centre for Dental Education and Research,AIIMS,Ansari Nagar,
South DELHI
New Delhi-110029
Centre for dental education and research
AIIMS , new delhi
New Delhi
DELHI
110029
India |
| Phone |
9818936926 |
| Fax |
|
| Email |
apexlogani@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Ajay Logani |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Department of Conservative Dentistry and Endodontics, Centre for Dental Education and Research,AIIMS,Ansari Nagar,
South DELHI
New Delhi-110029
Centre for dental education and research
AIIMS , new delhi
New Delhi
DELHI
110029
India |
| Phone |
9818936926 |
| Fax |
|
| Email |
apexlogani@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, Third Floor, Centre for Dental Education
and Research, AIIMS, Ansari Nagar, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
Centre for Dental Education and Research |
| Address |
AIIMS, Ansari Nagar, New Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Archana Aravind |
Centre for Dental Education and Research |
Department of
Conservative Dentistry
and Endodontics,Third
Floor CDER, AIIMS,
New Delhi-110029
South
DELHI
New Delhi
DELHI |
9947663992
archna.arvind@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research,AIIMS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
full pulpotomy performed with an inert material (gelatin sponge) |
The patient will be requested to rinse the oral cavity with 10 ml. of 0.2% Chlorhexidine digluconate Inferior alveolar nerve block (IANB) will be administered to anesthetize the tooth. After 15minutes of IANB, the tooth will be subjected to EPT. A negative response would ensure the successful nerve block. Supplemental technique (Intraosseous injection/Intraligamentary/Intrapulpal injection) will be used to achieve anesthesia of the pulp in cause of failure of primary IANB. Once the anesthesia is achieved tooth will be isolated with rubber dam placement. The carious tooth structure will be removed and any missing proximal wall will be restored with composite. The access to pulp chamber will be gained using a round diamond bur operated at high speed under air water coolant. The inflamed coronal pulp tissue will be excised using a spoon excavator until the canal orifice.
Visual inspection will be done for the presence of bleeding pulp tissue from all canals to confirm the pulp vitality. A pellet moistened with 2.5% NaOCl will be applied at the orifices for 2 min with a dry pellet on top for control of bleeding and will be repeated if required up to 10 min; bleeding time will be recorded. Once the haemostasis will be achieved, an inert material (gelatin sponge) will be placed above the pulpal floor. Above that a layer of RMGIC will be placed and light cured for 20s. The teeth will be finally restored with resin composite following the standard protocol and manufactures instructions. Rubber dam will be removed and occlusion will be checked, finishing and polishing will be accomplished with the appropriate polishing cups, points or both after the necessary occlusion adjustment.
|
| Comparator Agent |
full pulpotomy performed with MTA |
The patient will be requested to rinse the oral cavity with 10 ml. of 0.2% Chlorhexidine digluconate. Inferior alveolar nerve block (IANB) will be administered to anesthetize the tooth. After 15minutes of IANB, the tooth will be subjected to EPT. A negative response would ensure the successful nerve block. Once the anesthesia is achieved tooth will be isolated with rubber dam placement. The carious tooth structure will be removed and any missing proximal wall will be restored with composite. The access to pulp chamber will be gained using a round diamond bur operated at high speed under air water coolant. The inflamed coronal pulp tissue will be excised using a spoon excavator until the canal orifice.
Visual inspection will be done for the presence of bleeding pulp tissue from all canals to confirm the healhy vital pulp. A pellet moistened with 2.5% NaOCl will be applied at the orifices for 2 min with a dry pellet on top for control of bleeding and will be repeated if required up to 10 min; bleeding time will be recorded. Once the haemostasis will be achieved, ProRoot MTA will be mixed according to manufacturer’s instructions and placed in a 2-3 mm layer above the pulp tissue and gently packed using a condenser. A layer of RMGIC will be placed over ProRoot MTA and light cured for 20s. The teeth will be finally restored with resin composite following the standard protocol and manufactures instructions. Rubber dam will be removed and occlusion will be checked, finishing and polishing will be accomplished with the appropriate polishing cups, points or both after the necessary occlusion adjustment
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy patient of either gender between 18-35 years of age group.
2.Teeth with definitive clinical diagnosis of mechanical pulp exposure with reversible/irreversible pulpitis without symptomatic apical periodontitis.
3.Positive response to cold and electric pulp testing.
4.The tooth is restorable.
5.Probing pocket depth and mobility are within normal limits.
|
|
| ExclusionCriteria |
| Details |
1.Teeth with definitive clinical diagnosis of irreversible pulpitis which are associated with periapical rarefaction.
2.Teeth with immature roots.
3.Teeth with cracks, cusp fractures.
4.Teeth with poor periodontal health, probing pocket depth >3mm, furcation involvement and radiographic horizontal or vertical interdental bone loss.
5.Presence of sinus tract or swelling or periapical pathology on an IOPA radiograph.
6.Patients with systemic conditions which could compromise the healing.
7.Patients not willing to participate in the study
8.Bleeding cannot be controlled within 10 mins with pressure pack.
9.Clinical diagnosis changes from symptomatic irreversible pulpitis to pulp necrosis
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate clinically and radiographically the outcome of full pulpotomy performed in mature permanent teeth with mechanical pulp exposure with use of,
a) Mineral Trioxide Aggregate
b) Inert Material ( Gelatin Sponge)
|
3months, 6months, 12months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate clinically and radiographically the outcome of full pulpotomy performed in mature permanent teeth with mechanical pulp exposure with use of,
a) Mineral Trioxide Aggregate
b) Inert Material ( Gelatin Sponge)
|
3months, 6months, 12months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/05/2019 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Pulpotomy is the removal of the coronal portion of a vital pulp as a means of preserving the vitality of the remaining radicular portion. There are many factors affecting the success of pulpotomy, one of most critical is the sealing ability of the materials used Inspite of having higher success rate, pulpotomy procedure is not performed routinely as that of non surgical endodontic therapy as these materials are very expensive and it may limit their use in both developing as well as developed countries.. So, in order to know the influence of calcium silicate based cements on the outcome of full pulpotomy a study was designed to evaluate clinically and radiographically the outcome of full pulpotomy performed in mature permanent teeth with mechanical pulp exposure with use of a) Mineral Trioxide Aggregate, b) Inert Material ( Gelatin Sponge) For this study, full pulpotomy will be performed on bilateral similar teeth with mechanical pulp exposure and a suitable pulp capping agent will be place dover the remaining pulp tissue in two groups as follows: Group- I: Pulpotomy performed with MTA Group- II: Pulpotomy performed with Inert material (Gelatin sponge) In both the groups post endodontic restoration will be completed with glass ionomer cemnt and composite resin. The patient followup will be done at 3, 6 and 12 months interval clinically and radiographically. Clinically presence or absence of symptoms will be assessed. The radiographs will be taken to observe the dentin bridge formation and to assess the periapical index(PAI) score. And the results will be statistically analyzed. |