| CTRI Number |
CTRI/2025/02/080563 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the effectiveness of different materials to protect and heal the tooths inner tissue (the pulp) when its exposed during treatment of deep cavities |
|
Scientific Title of Study
|
Comparing the Efficacy of Various Direct Pulp Capping Agents on Dentin Bridge Formation – A Clinical Study.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Agarwal Namrata |
| Designation |
Post graduate |
| Affiliation |
Army college of Dental Sciences |
| Address |
Room-9, Department of Conservative Dentistry and Endodontics, Army College of Dental Sciences, Jai Jawahar Nagar, CRPF Road,
Secunderabad
Telangana
Medchal
TELANGANA
500087
India |
| Phone |
08197196704 |
| Fax |
|
| Email |
dr.namrataagarwalendo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mamta Kaushik |
| Designation |
Head of Department and Principle- Army College of Dental Sciences |
| Affiliation |
Army college of Dental Sciences |
| Address |
Room-9, Department of Conservative Dentistry and Endodontics, Army College of Dental Sciences, Jai Jawahar Nagar, CRPF Road,
Secunderabad
Telangana
Medchal
TELANGANA
500087
India |
| Phone |
08197196704 |
| Fax |
|
| Email |
mamkaushik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Agarwal Namrata |
| Designation |
Post graduate |
| Affiliation |
Army college of Dental Sciences |
| Address |
Room-9, Department of Conservative Dentistry and Endodontics, Army College of Dental Sciences, Jai Jawahar Nagar, CRPF Road,
Secunderabad
Telangana
TELANGANA
500087
India |
| Phone |
08197196704 |
| Fax |
|
| Email |
dr.namrataagarwalendo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 9, Department of conservative Dentistry and Endodontics
Army College of Dental Sciences,
CRPF road, Secunderabad, Telangana 500087 |
| Safe Endo MTA |
|
|
Primary Sponsor
|
| Name |
Agarwal Namrata |
| Address |
Room-9, Department of Conservative Dentistry and Endodontics, Army college of Dental Sciences, Secunderabad, Telangana 500087 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr Agarwal Namrata |
Army college of Dental Sciences |
Room-9, Department of Conservative Dentistry and Endodontics, Army college of Dental Sciences, Secunderabad, Telangana 500087
Medchal
TELANGANA |
08197196704
dr.namrataagarwalendo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Army college of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asymptomatic or Symptomatic reversible pulpitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MTA |
Caries excavation followed by application of MTA/Propolis hydrogel/simvastatin hydrogel/platelet rich fibrin on the exposed pulp and evaluation after 3months,6months and 12months
|
| Intervention |
Platelet rich fibrin |
Caries excavation followed by application of MTA/Propolis hydrogel/simvastatin hydrogel/platelet rich fibrin on the exposed pulpand evaluation after 3months,6months and 12months
|
| Intervention |
Propolis hydrogel
|
Caries excavation followed by application of MTA/Propolis hydrogel/simvastatin hydrogel/platelet rich fibrin on the exposed pulp and evaluation after 3months,6months and 12months
|
| Intervention |
Simvastatin hydrogel |
Caries excavation followed by application of MTA/Propolis hydrogel/simvastatin hydrogel/platelet rich fibrin on the exposed pulpand evaluation after 3months,6months and 12months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Asymptomatic maxillary and mandibular molars with caries.
No tenderness to percussion.
Ideal periodontal probing depth of 2 to 3 mm.
Normal response to cold and electric pulp testing.
Radiographic evidence of deep caries approximating the pulp chamber with no evidence of thickening/ widening of periodontal ligament.
Absence of furcation radiolucencies and periapical pathology.
|
|
| ExclusionCriteria |
| Details |
Symptomatic teeth (history of spontaneous pain).
Radiographic evidence of periapical changes or pathology.
Negative response to pulp sensibility testing.
History of systemic diseases.
Tooth not conducive for rubber dam isolation.
History of previous restoration in the tooth under consideration for pulp capping.
Periodontally compromised teeth.
Patients with bleeding disorders.
Patients with unsatisfactory oral hygiene maintenance.
Pregnant and lactating females.
Uncooperative patients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The volume of dentin bridge formed after direct pulp capping with Platelet RichFibrin, Propolis extract, Simvastatin gel and MTA |
3months,6months,12months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical response to the direct pulp capping agents |
3months,6months,12 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
27/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The participants reaching the inclusion criteria are selected. After obtaining informed consent, the direct pulp capping procedure is initiated with the administration of local anesthesia and the placement of rubber dam isolation. Carious lesions are thoroughly excavated, and upon pulp exposure, if hemostasis is achieved, appropriate pulp capping agents are applied. There are four pulp capping agents- MTA , Platelet rich fibrin, Simvastatin hydrogel and Propolis hydrogel. For preparation of PRF- The patients’ blood will be collected without
anticoagulant and the tube will be placed immediately after
collection into the centrifuge for 12mins at 2700 rpm. The intermediate layer obtained will be placed on the pulp exposure. For preparation of propolis hydrogel- Maceration of 500 grams of raw propolis will be
done with 500ml of 96 % ethanol in a closed container for 14 days. The brown extract obtained will be mixed with poloxamar and methylcellulose to form a hydrogel For preparation of simvastatin hydrogel- Pure simvastatin will be obtained. 1.2% Simvastatin hydrogel will be prepared by mixing with poloxamar and methylcellulose.
The pulp capping agents will be placed on the exposed pulp, a layer of glass ionomer cement will be applied and permanent restoration will be done with composite.
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