| CTRI Number |
CTRI/2026/01/102593 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical evaluation of proximal restorations with bulk fill and fiber reinforced composites 1 year follow up |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF PROXIMAL RESTORATIONS WITH PREHEATING BULK FILL AND FIBER REINFORCED COMPOSITES A RANDOMIZED CLINICAL TRIAL 1YEAR FOLLOW UP |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TAMANAMPUDI LAKSHMI MANJUSHA |
| Designation |
POST GRADUATE |
| Affiliation |
Drs Sudha and Nageswara rao siddhartha institute of dental sciences |
| Address |
Department of conservative dentistry and endodontics room no 7 Chinnaoutpalli Gannavaram mandal Krishna district
Department of conservative dentistry and endodontics room no 7 Chinnaoutpalli Gannavaram mandal Krishna district
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9494173063 |
| Fax |
|
| Email |
manjushareddy01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J RAVI KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
Drs Sudha and Nageswara rao siddhartha institute of dental sciences |
| Address |
Department of conservative dentistry and endodontics room no 7 Chinnaoutpalli Gannavaram mandal Krishna district
Department of conservative dentistry and endodontics room no 7 Chinnaoutpalli Gannavaram mandal Krishna district
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9440250244 |
| Fax |
|
| Email |
drkumarjanga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr J RAVI KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
Drs Sudha and Nageswara rao siddhartha institute of dental sciences |
| Address |
Department of conservative dentistry and endodontics room no 7 Chinnaoutpalli Gannavaram mandal Krishna district
Department of conservative dentistry and endodontics room no 7 Chinnaoutpalli Gannavaram mandal Krishna district
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9440250244 |
| Fax |
|
| Email |
drkumarjanga@gmail.com |
|
|
Source of Monetary or Material Support
|
| TAMANAMPUDI LAKSHMI MANJUSHA Drs Sudha and Nageswara rao siddhartha institute of dental sciences Department of conservative dentistry and endodontics Chinnaoutpalli Gannavaram mandal Andhra Pradesh India 521286 |
|
|
Primary Sponsor
|
| Name |
TAMANAMPUDI LAKSHMI MANJUSHA |
| Address |
Drs Sudha and Nageswara rao siddhartha institute of dental sciences Department of conservative dentistry and endodontics Chinnaoutpalli Gannavaram mandal Andhra Pradesh India 521286 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 TAMANAMPUDI LAKSHMI MANJUSHA |
Drs Sudha and Nageswara rao siddhartha institute of dental sciences |
Department of conservative dentistry and endodontics Room no 7 Chinnaoutpalli Gannavaram mandal
Krishna
ANDHRA PRADESH |
9494173063
manjushareddy01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Drs SUDHA AND NAGESWARA RAO RAO INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K02||Dental caries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GC Ever X Posterior |
Fiber reinforced composite with Garrison Composi - tight 3D fusion sectional matrix system 1 year follow up |
| Intervention |
Parkell Predicta bioactive Bulk fill |
Bulk fill composite with Garrison Composi - tight 3D fusion sectional matrix system 1 year follow up |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Aged between (18–60) years old
Having single primary ICDAS score 4
D3 radiographic score
Proximal cavities with vital carious premolars and molar with sound adjacent and opposing teeth will be selected |
|
| ExclusionCriteria |
| Details |
Pathologic Pulpal diagnosis with pain non vital teeth
Exceeds 4 mm in depth
Periodontal problems
Bruxism & xerostomia
Fractured or visibly cracked teeth
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| USPHS CRITERIA |
Base line, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Marginal adaptation
Marginal discoloration
Postoperative sensitivity
Secondary caries
Surface texture
Anatomical form
Color match
Retention
|
Base line, 6 months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
22/02/2026 |
| 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
|
Comparative evaluation of preheated bulk fill and fiber reinforced composites in proximal cavities using USPHS Criteria , a one year follow up study using the sectional matrix system And the purpose of the study was There are several in vitro studies demonstrating the benefits of preheated composites and There are limited clinical trails investigating the impact of preheating of bulkfill and fiber reinforced composites and it was valuable to assess and compare the clinical performance of posterior restorations with preheated bulk fill and fiber reinforced versus non preheated bulk fill and fiber reinforced composites
|