| CTRI Number |
CTRI/2019/01/016939 [Registered on: 07/01/2019] Trial Registered Prospectively |
| Last Modified On: |
28/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different techniques of filling the cavitated or fractured tooth |
|
Scientific Title of Study
|
Comparative clinical evaluation of incrementally-filled and bulk-filled composites- a split mouth randomized 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 |
Dr Karuna Y M |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Dental Sciences, Mangalore |
| Address |
Assistant Professor, Department of Pedodontics and Preventive Dentistry, Light House Hill, MCODS, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7907196265 |
| Fax |
|
| Email |
karuna.ym@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karuna Y M |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Dental Sciences, Mangalore |
| Address |
Assistant Professor, Department of Pedodontics and Preventive Dentistry, Light House Hill, MCODS, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7907196265 |
| Fax |
|
| Email |
karuna.ym@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karuna Y M |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Dental Sciences, Mangalore |
| Address |
Assistant Professor, Department of Pedodontics and Preventive Dentistry, Light House Hill, MCODS, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7907196265 |
| Fax |
|
| Email |
karuna.ym@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences, Mangalore |
|
|
Primary Sponsor
|
| Name |
Manipal College of Dental Sciences Mangalore |
| Address |
Light House Hill road, Mangalore 575001 |
| Type of Sponsor |
Other [Private Dental College] |
|
|
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 Karuna YM |
Department of Conservative dentistry and Department of Paedodontics, Room Number 3 and 5 |
Manipal College of Dental Sciences, Light House Hill Road, Mangalore
Dakshina Kannada
KARNATAKA |
7907196265
karuna.ym@manipal.edu |
|
|
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 |
those who seek treatment for dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bulk Filled composite |
teeth indicated will be restored using bulk fill composite technique and material |
| Comparator Agent |
Incrementally filled composite restoration |
indicated teeth will be filled using incremental fill technique and material |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients/ parents of patients who have given the informed consent
2. Patients having minimum two anterior teeth which require large direct composite restorations to be done either due to caries (not involving pulp) or Elli’s class II fractures.
3. Patients in good in general health
4. A history of regular dental attendance and who were agreeable to return for the evaluation (assessment) appointment |
|
| ExclusionCriteria |
| Details |
1. Teeth with any signs/symptoms of pulpitis/ periapical/ periodontal infections.
2. Patients with a history of any adverse reaction to the class of restorative materials used in the study.
3. Differently abled patients due to underlying systemic/ physical or psychological disabilities. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical success rate of the restoration |
Clinical success rate of the restoration will be assessed after 6 months and after 12 months of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Less chair side time and cost effectiveness |
restoration will be assessed after 6 months and 12 months of restoration |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/01/2019 |
| Date of Study Completion (India) |
23/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Implications of the study: Bulk filling composites are definitely a boon to restorative dentistry, specially the pediatric dentistry as they save a lot of chairside time, thereby enhancing the quality treatment time for both patient and the clinician. However, bulk fill composites are relatively novel and performance of the same under clinical conditions is unknown. If through this In vivo follow up study, if bulk fill composites prove to be equally or more efficacious than the incrementally filled composites, we may opt for bulk fill composites in most of the clinical scenario. |