| CTRI Number |
CTRI/2025/07/091278 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [ new technique of restoration of teeth is compared with the conventional technique] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
study to evaluate efficient composite restoration technique |
|
Scientific Title of Study
|
Evaluation of bite force between conventional direct composite restoration technique and occlusal stamp technique- a comparative 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 |
Dr Dhanya Joseph Madassery |
| Designation |
Post Graduate student |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Pediatric and Preventive Dentistry
The Oxford Dental College Bommanahalli NH 44 Hongasandra Bengaluru Karnataka 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
8289915515 |
| Fax |
|
| Email |
dhanyarejo14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhusudhan KS |
| Designation |
Reader |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Pediatric and Preventive Dentistry
The Oxford Dental College Bommanahalli NH 44 Hongasandra Bengaluru Karnataka 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
9886035137 |
| Fax |
|
| Email |
sudhannks@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhusudhan KS |
| Designation |
Reader |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Pediatric and Preventive Dentistry
The Oxford Dental College Bommanahalli NH 44 Hongasandra Bengaluru Karnataka 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
9886035137 |
| Fax |
|
| Email |
sudhannks@gmail.com |
|
|
Source of Monetary or Material Support
|
| The oxford dental college and hospital
Bommanahalli, NH 44, Hongasandra, Bengaluru, Karnataka 560068 |
|
|
Primary Sponsor
|
| Name |
Dr Dhanya Joseph Madassery |
| Address |
The Oxford Dental College
Bommanahalli, NH 44, Hongasandra, Bengaluru, Karnataka 560068 |
| 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 Dhanya Joseph Madassery |
The Oxford Dental College |
Room No.8
Department of Pediatric and Preventive Dentistry
The Oxford Dental College Bommanahalli NH 44 Hongasandra Bengaluru Karnataka 560068
Bangalore
KARNATAKA |
08289915515
dhanyarejo14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
composite resin restoration |
occlusal stamp technique |
| Intervention |
composite resin restoration for carious lesions |
conventional technique |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged between 7years to 14 years.
2. Patients with bilateral class 1 cavity (ICDAS code 2 to 4) on permanent mandibular first molar.
|
|
| ExclusionCriteria |
| Details |
1. Patients with TMJ disorders, craniomandibular dysfunction
2. Patients with intellectual disability
3. Patients with acute pain or abscess
4. Patients with nonocclusion in the posterior region
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The occlusal stamp technique is more accurate than the conventional technique |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time required for finishing & polishing in both the techniques |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
17/08/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Imbalances in occlusal forces due to poor dental restoration result in mal- aligned teeth and difficulties in speech and mastication. The main objective is to compare and evaluate the bite force after the fabrication of composite restorations using occlusal stamp technique and conventional technique. Initially, bite force of the involved teeth is recorded bilaterally using an occlusal bite force meter. The first phase of making the occlusal matrix (stamp) involves cleaning and drying of the occlusal surface. Flowable composite is applied over the occlusal surface and an applicator tip wet with bonding agent is embedded in the composite and light cured, removed off the occlusal surface and used as occlusal stamp. The caries is excavated, cavity prepared, acid etched, bonded, packed with composite. After the last 1-2mm thick increment of composite resin into the cavity, prior to curing, a Teflon tape is placed over the increment, the fabricated occlusal stamp is pressed against the surface to allow the stamp to adapt to the uncured composite. Teflon tape followed by excess composite is removed and light cured. Prior to finishing and polishing and after polishing, the occlusal bite force is recorded. On the contralateral side, composite is restored using conventional technique and bite force recorded similar to the occlusal stamp technique. The hypothesis of the study is that the occlusal stamp technique will give a better occlusal anatomy than the conventional technique |