| CTRI Number |
CTRI/2026/03/105706 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Stainless steel crowns and Composite onlays in patients with Molar incisor hypomineralisation |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF STAINLESS STEEL CROWNS AND COMPOSITE ONLAYS ON PERMANENT FIRST MOLARS AFTER ROOT CANAL TREATMENT IN PATIENTS WITH MOLAR INCISOR HYPOMINERALIZATION: AN IN-VIVO STUDY. |
| Trial Acronym |
Stainless steel crown and Composite onlay |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Brinda BK |
| Designation |
Postgraduate |
| Affiliation |
Al Azhar Dental College |
| Address |
Al Azhar Dental College
Perumpillichira PO
Thodupuzha
Idukki
Idukki
KERALA
685605
India |
| Phone |
8075726903 |
| Fax |
|
| Email |
brindabkallikodan1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bijimole Jose |
| Designation |
Head of the Department |
| Affiliation |
Al Azhar Dental College |
| Address |
Al Azhar Dental College
Perumpillichira PO
Thodupuzha
Idukki
Idukki
KERALA
685605
India |
| Phone |
9446209105 |
| Fax |
|
| Email |
bijijose7812@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Brinda BK |
| Designation |
Postgraduate |
| Affiliation |
Al Azhar Dental College |
| Address |
Al Azhar Dental College
Perumpillichira PO
Thodupuzha
Idukki
Idukki
KERALA
685605
India |
| Phone |
8075726903 |
| Fax |
|
| Email |
brindabkallikodan1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Al Azhar Dental College
Perumpillichira PO
Thodupuzha
Idukki
Kerala
India
685605 |
|
|
Primary Sponsor
|
| Name |
Brinda BK |
| Address |
Al Azhar Dental College
Perumpillichira PO
Thodupuzha
Idukki
Kerala
685605
Idukki |
| 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 Brinda BK |
Al Azhar Dental College |
Department of Paedodontics
Al Azhar Dental College
Perumpillichira PO
Thodupuzha
Idukki
Idukki
KERALA |
08075726903
brindabkallikodan1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Al Azhar Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Molar incisor hypomineralisation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
composite onlay |
After root canal procedure for children with molar incisor hypomineralisation, the root canal treated molar will be restored with composite onlay for the intervention group |
| Comparator Agent |
Stainless steel crown |
After root canal procedure for children with molar incisor hypomineralisation, the root canal treated molar will be restored with stainless steel crown for the control group |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Children who require root canal treatment on permanent first molars with severe hypomineralisation |
|
| ExclusionCriteria |
| Details |
Children under mild stages of hypomineralisation on permanent first molars not involving the pulp.
Children with signs of fluorosis, tetracycline staining, amelogenesis imperfecta, and generalised enamel hypoplasia.
Children who are allergic to metals |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess marginal adaptation, retention, aesthetics, wear resistance and gingival health for molar with stainless steel crowns and composite onlays in children with molar incisor hypomineralisation |
At baseline, 6 months and 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess marginal adaptation, retention, aesthetics, wear resistance & gingival health for molar with stainless steel crowns & composite onlays in children with molar incisor hypomineralisation |
At baseline, 6 months & 1 year |
|
|
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 3 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| 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)
|
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
|
This in-vivo randomized controlled trial evaluates the clinical performance of stainless steel crowns and composite onlays in permanent first molars affected by molar incisor hypomineralization after root canal treatment. Thirty children aged 8–13 years will be randomly allocated into two groups (n=15 each): Group A receiving stainless steel crowns and Group B receiving composite onlays. Sample size was calculated using comparison of two proportions formula with 80% power and 95% confidence level. Outcomes including retention, marginal adaptation, aesthetics, wear resistance (Modified USPHS criteria) and gingival health (Gingival Index) will be assessed at baseline, 6 months, and 1 year and statistically analyzed. |