| CTRI Number |
CTRI/2023/04/051969 [Registered on: 25/04/2023] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
REGENERATIVE POTENTIAL OF AMNIOTIC MEMBRANE, HYALURONIC ACID GEL AND MTA |
|
Scientific Title of Study
|
COMPARITIVE EVALUATION OF AMNION MEMBRANE, HYALURONIC ACID GEL AND MINERAL TRIOXIDE AGGREGATE AS DIRECT PULP CAPPING AGENTS USING CONE BEAM COMPUTED TOMOGRAPHY - A RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
YAMINI PRIYA P |
| Designation |
PG STUDENT |
| Affiliation |
TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL |
| Address |
304, TAMILNADU GOVERNMENT DENTAL COLLEGE LADIES HOSTEL, MUTHUSAMY SALAI, OPP. TO FORT RAILWAY STATION, CHENNAI
ESPLANADE, GEORGE TOWN, CHENNAI
Chennai
TAMIL NADU
600003
India |
| Phone |
8925359359 |
| Fax |
|
| Email |
yaminipriya996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR M KAVITHA |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of Conservative dentistry and Endodontics,
Tamilnadu Government dental college and hospital, Chennai
Chennai
ESPLANADE, GEORGE TOWN, CHENNAI
Chennai
TAMIL NADU
600003
India |
| Phone |
9841161131 |
| Fax |
|
| Email |
kavithaendo@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
YAMINI PRIYA P |
| Designation |
PG STUDENT |
| Affiliation |
TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL |
| Address |
TAMILNADU GOVERNMENT DENTAL COLLEGE LADIES HOSTEL, MUTHUSAMY SALAI, OPP. TO FORT RAILWAY STATION, CHENNAI
ESPLANADE, GEORGE TOWN, CHENNAI
Chennai
TAMIL NADU
600003
India |
| Phone |
8925359359 |
| Fax |
|
| Email |
yaminipriya996@gmail.com |
|
|
Source of Monetary or Material Support
|
| TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL, ESPLANADE, GEORGE TOWN, CHENNAI 600003 |
|
|
Primary Sponsor
|
| Name |
YAMINI PRIYA P |
| Address |
TAMILNADU GOVERNMENT DENTAL COLLEGE LADIES HOSTEL, MUTHUSAMY SALAI, CHENNAI 600003 |
| 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 YAMINI PRIYA |
TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, ROOM 110
Chennai
TAMIL NADU |
8925359359
yaminipriya996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AMNIOTIC MEMBRANE |
HUMAN AMNIOTIC MEMBRANE PROCURED FROM TATA MEMORIAL TISSUE BANK IS CUT INTO SPECIFIC SIZE AND PLACED ON EXPOSED PULP AND PATIENT IS FOLLOWED FOR 6 MONTHS |
| Intervention |
HYALURONIC ACID GEL |
COMMERCIALLY AVAILABLE HYALURONIC ACID GEL PLACED ON PULPAL EXPOSURE SITE AND FOLLOWED FOR 6 MONTHS |
| Comparator Agent |
MINERAL TRIOXIDE AGGREGATE |
COMMERCIALLY AVAILABLE MINERAL TRIOXIDE AGGREGATE POWDER IS MIXED WITH LIQUID AND PLACED ON PULPAL EXPOSURE SITE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients with asymptomatic maxillary and mandibular premolars and molars with radiographic evidence of deep caries approximating the pulp chamber
Absence of tenderness to percussion and positive response to cold and electric pulp testing
Periodontally healthy individuals
Patients with no systemic disease
Patients willing for voluntary participation and have signed the informed consent
Patients with good oral hygiene
|
|
| ExclusionCriteria |
| Details |
Symptomatic teeth
Evidence of periapical pathology
Negative response to pulp vitality testing
Patient with known systemic diseases
Teeth not conducive for rubber dam isolation
History of previous restorations
Periodontally compromised teeth
Pregnant women, in view of requirements for radiographs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ASYMPTOMATIC VITAL TOOTH WITH NORMAL PULPAL RESPONSE ON VITALITY TEST |
1, 3 AND 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REPARATIVE DENTIN BRIDGE FORMATION ASSESSED USING CBCT |
3 MONTHS |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2023 |
| 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="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
THIS RANDOMIZED CONTROLLED TRIAL IS TO COMPARE HUMAN AMNIOTIC MEMBRANE AND HYALURONIC ACID GEL WITH MINERAL TRIOXIDE AGGREGATE AS DIRECT PULP CAPPING AGENTS USING CONE BEAM COMPUTED TOMOGRAPHY CONDUCTED IN TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL AMONG 30 PATIENTS OF AGE GROUP 18 TO 30 WITH DEEP DENTAL CARIES APPOXIMATING PULP. THE PRIMARY OUTCOME SHOULD BE ASYMPTOMATIC VITAL TOOTH RESPONDING NORMALLY TO VITALITY TEST WITH SECONDARY OUTCOME REVEALING RADIOGRAPHIC EVIDENCE OF DENTIN BRIDGE FORMATION AT 3 AND 6 MONTHS AND CBCT EVALUATION AT 3 MONTHS |