| CTRI Number |
CTRI/2025/01/079306 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of composites in class I compound restorations |
|
Scientific Title of Study
|
A comparative evaluation of the clinical performance of bulk-fill and preheated bulk-fill composite resin in class I compound restorations by using custom shield technique A randomized controlled trial. |
| 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 Shilpa Nirankari |
| Designation |
post graduate student |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
Department Of Conservative Dentistry and Endodontics, Government Dental College and Hospital Nagpur,Medical Square, Hanuman Nagar, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
7773944365 |
| Fax |
|
| Email |
dinkykukreja16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjusha M Warhadpande |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
Department Of Conservative Dentistry and Endodontics, Government Dental College and Hospital Nagpur,Medical Square, Hanuman Nagar, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9834513896 |
| Fax |
|
| Email |
manjushawarhadpande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjusha M Warhadpande |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
Department Of Conservative Dentistry and Endodontics, Government Dental College and Hospital Nagpur,Medical Square, Hanuman Nagar, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9834513896 |
| Fax |
|
| Email |
manjushawarhadpande@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and hospital, medical square, hanuman nagar, nagpur, maharashtra,440003 |
|
|
Primary Sponsor
|
| Name |
Dr shilpa Nirankari |
| Address |
Department of conservative dentistry and endodontics, Government Dental College and Hospital Nagpur, Maharashtra,440003 |
| 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 Shilpa Nirankari |
Government dental college and hospital,Nagpur |
117, Post Graduate Section, Department of Conservative dentistry and Endodontics, Government Dental College and Hospital, Nagpur
Nagpur
MAHARASHTRA |
7773944365
dinkykukreja16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee, Government Dental College and Hospital,Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bulk-fill composite |
teeth with class I compound caries restored with bulk-fill composite resin by using custom shield technique will be evaluated for 12 months |
| Intervention |
Preheated bulk-fill composite |
Teeth with class I compound caries restored with preheated bulk-fill composite resin by using custom shield technique will be evaluated 12 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged between 18 to 60 years.
2.Patients with class I compound lesion in permanent molars with caries score 3 & 4 of ICDAS II criteria
|
|
| ExclusionCriteria |
| Details |
1.Patients with deep carious lesions.
2.Patients with compromised periodontal health.
3.Patients who is medically compromised.
4.Pregnant womens .
5.Patients with parafunctional habit.
6.Patients with malpositioned teeth.
7.Patients sensitive to local anaesthesia & latex.
8.Patients not willing to participate.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The clinical performance of bulk fill and Preheated bulk-fill composite resin in class I compound restorations will be evaluated by two evaluators according to the Modified USPHS criteria . |
baseline,6 months,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare clinical performance of bulk-fill and preheated bulk-fill composite resin in class I compound restorations with ‘custom shield technique’ |
baseline, 6 months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
05/02/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The massive introduction of various fluoridated agents appears to have altered the morphological factor in the development of dental caries. This led to hidden carious lesions which have an intact occlusal surface and hence are occult. Nowadays for restoring such carious lesions the earlier concept of prophylactic extension is being displaced by minimally invasive dentistry, which focuses on preserving the sound dental structure. The posterior composite resin restorations are the standard in modern dentistry, which is moving towards Biomimetic dentistry aiming to restore the natural contour & function of the original tooth & it is also important to achieve a harmonious occlusal & cusp fossa relationship in posterior tooth cavity restoration. The direct restorations are time-consuming, technically sensitive, and may not result in correct replication of the form and occlusion. Frequently, along with occlusal surfaces, the buccal and lingual surfaces can be affected by hidden caries and be lost during caries excavation. To resolve all these problems in the class I compound lesions, Gaetano Paolone and Salvatore Scolavino and the style Italiano team introduced the custom shield technique. This technique utilizes putty index for recording the height and anatomy of the buccal/palatal cusp before its reduction. Restoration of natural contours using bulk-fill composite resin becomes difficult because of more viscous nature. it does not get adapted properly to putty index. To improve the adaptation of viscous bulk-fill composite resin, preheating of bulk-fill composite resin is done. Pre-heating of bulk-fill and conventional restorative composites prior to photoactivation decreases polymerization-induced shrinkage forces without compromising the degree of conversion & improves marginal adaption. |