| CTRI Number |
CTRI/2026/02/104248 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Adaptability and Success of Full Coverage Crowns on Children Teeth. |
|
Scientific Title of Study
|
BITE FORCE AND FUNCTIONAL CHANGES OF
PRIMARY MOLARS RESTORED WITH
PREFORMED STAINLESS-STEEL CROWNS AND
BIOFLX CROWNS USING DIGITAL OCCLUSAL
ANALYSIS: 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 |
Dr Anjana K S |
| Designation |
Post graduate |
| Affiliation |
Rajarajeswari Dental College and Hospital bangalore |
| Address |
Rajarajeswari Dental College and Hospital , Room no-6 Department of pediatric and preventive dentistrty .
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9108635473 |
| Fax |
|
| Email |
anjuanjanaks@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagarathna C |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Dental College and Hospital bangalore |
| Address |
Rajarajeswari Dental College and Hospital , Room no-6 Department of pediatric and preventive dentistrty .
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9845581779 |
| Fax |
|
| Email |
shaanrathna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjana K S |
| Designation |
Post graduate |
| Affiliation |
Rajarajeswari Dental College and Hospital bangalore |
| Address |
Rajarajeswari Dental College and Hospital , Room no-6 Department of pediatric and preventive dentistrty .
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9108635473 |
| Fax |
|
| Email |
anjuanjanaks@gmail.com |
|
|
Source of Monetary or Material Support
|
| RajaRajeswari Dental College and Hospital ,room no 6 Department of Pediatric and Preventive Dentistry ,No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074 |
|
|
Primary Sponsor
|
| Name |
Dr Anjana K S |
| Address |
Rajarajeswari Dental College and Hospital , Room no-6 Department of pediatric and preventive dentistrty .
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Anjana K S |
RajaRajeswari Dental College and Hospital |
Room no-6 ,Department of Pediatric and Preventive Dentistry No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Bangalore Rural
KARNATAKA |
9108635473
anjuanjanaks@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari Dental College 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, (2) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inter-group comparison among the three full-coverage crown techniques |
Each intervention group acts as a comparator to the other two groups. The following comparisons will be made
Occlusal load and bite force measurements recorded at T0 (baseline), T1 (immediate post-treatment), T2 (1 week), and T3 (1 month) using T Scan III will be statistically compared between groups to evaluate differences in bite strength and functional occlusion over time. |
| Intervention |
Placement of Stainless Steel Crowns using Hall Technique |
A total of 15 primary molars will receive Stainless-Steel Crowns using the Hall technique (without conventional tooth preparation). |
| Intervention |
Tooth preparation and placement of Bioflx Crowns |
A total of 15 primary molars will receive tooth preparation followed by placement of Bioflx crowns. |
| Intervention |
Tooth preparation and placement of Stainless Steel Crowns |
A total of 15 primary molars will receive conventional tooth preparation followed by placement of Stainless-Steel Crowns. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Children in good general health, aged between 6 to 9 years from either gender.
2.Presence of intact dentition with normal molar relation requiring unilateral placement of
full coverage restoration in the treatment plan.
3.Hall technique crowns
primary molar caries involving dentine, but not extending into the pulp with detectable cervical constriction and at least two surfaces and a part of the occlusal surface is left intact.
4.Conventional Stainless-steel crowns and Bioflx crowns
Primary molar having multi-surface caries.
Primary molar with wide proximal lesion.
Primary molar requiring pulp therapy.
5.No gingival inflammation, no periodontal diseases, no mobility of teeth, or apparent facial
asymmetry that could affect recordings.
6.No history of orthodontic treatment. |
|
| ExclusionCriteria |
| Details |
1.Children with special health care conditions.
2.Patients with TMJ disorders.
3.Children with malocclusion.
4.Children with developmental anomalies.
5.Children with parafunctional habits,e.g bruxism |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluation of bite force and fucntional changes of conventional stainless steel crowns,hall technique crowns and bioflx crowns |
baseline
immediately after crown cementation 1day.
1 week after crown cementation.
1 month after crown cementation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparision of bite force and functional changes of conventional stainless steel crowns , hall crowns and bioflx crowns |
baseline
immediately after crown cementation day 1
1 week after crown cementation
1 month after crown cementation |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
10/08/2026 |
| 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="2"
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
|
A total of 45 primary molars from children aged 6 to 9 years with extensive dental caries requiring full coverage restorations by using preformed crowns will be enrolled.Teeth will be allocated equally among following three groups n equals 15 each.
Group 1 Tooth preparation and placement of Stainless steel crowns SSC. Group 2 Placement of Stainless steel crowns using Hall technique. Group 3 Tooth preparation and placement of Bioflx crowns.
Evaluation of Bite force and functional changes of full coverage crowns
Determination of occlusal load in maximum intercuspal position using T Scan III
Baseline Pretreatment evaluation T0 Children selected for the present study will be requested to bite on back teeth together several times from a 15 to 20 mm mandibular opening and the bite force will be checked to confirm repeatability on the primary molar Four consecutive recordings of the patients maximum intercuspal position will be taken A single examiner will record all the four readings of bite at maximum intercuspal position for each subject using T scan.
Post treatment Immediately after the placement of full coverage crown T1 After the placement of the full coverage crown on the selected molar occlusal load at maximum intercuspal position will be recorded using T Scan III as mentioned in the baseline evaluation T0 and the readings are recorded for further evaluation.
Post treatment measurements after one week T2 After one week follow up the maximum intercuspal position will be measured as mentioned in the baseline evaluation T0 and readings are recorded for further evaluation.
Post treatment measurements after one month T3 After one month follow up the maximum intercuspal position will be measured and recorded using T scan as mentioned in the baseline evaluation T0.
The outcomes assessed at T0 T1 T2 and T3 will be analyzed and compared statistically to determine changes in bite strength and functional occlusion over the follow up period. |