| CTRI Number |
CTRI/2023/09/057201 [Registered on: 01/09/2023] Trial Registered Prospectively |
| Last Modified On: |
01/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [dental] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical evaluation of class 2 restorations with bulk fill composite resins 1 year follow up |
|
Scientific Title of Study
|
CLINICAL EVALUVATION OF CLASS 2 RESTORATIONS WITH SELF ADHERING AND BULK FILL COMPOSITE RESINS A PROSPECTIVE RANDOMIZED CLINICAL STUDY:1 YEAR 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 |
VASANTHI DEEVI |
| Designation |
POST GRADUATE |
| Affiliation |
Drs SUDHA AND NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES |
| Address |
Drs SUDHA & NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
GANNAVARAM 521286
ANDHRA PRADESH
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9010811112 |
| Fax |
|
| Email |
vasanthideevi34@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 |
Drs SUDHA AND NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
GANNAVARAM 521286
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 |
Drs SUDHA AND NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES
GANNAVARAM 521286
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9440250244 |
| Fax |
|
| Email |
drkumarjanga@gmail.com |
|
|
Source of Monetary or Material Support
|
| VASANTHI DEEVI
Drs SUDHA AND NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES
Department of conservative dentistry and endodontics
GANNAVARAM |
|
|
Primary Sponsor
|
| Name |
Vasanthi Deevi |
| Address |
Drs SUDHA AND NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES
Department of conservative dentistry and endodontics
GANNAVARAM |
| 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 |
| VASANTHI DEEVI |
DRS SUDHA AD NAGESWARARAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES GANNAVARAM |
DEPARTMENT OF
CONSERVATIVE
DENTISTRY AND
ENDODONTICS
ROON NO 7
CHINNAOUTPALLI
GANNAVARAM MANDAL
Krishna
ANDHRA PRADESH |
9010811112
vasanthideevi34@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Class 2 dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Filtek |
Bulk fill composite
Palodent sectional matrix system |
| Intervention |
surefill one |
Self adhering composite with Palodent sectional matrix system |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
The Age between 18-50 years.
The patient should have one or two class 2 cavity in permanent tooth.
The Patient have no systemic disease.
The Patient should have good periodontal health.
Teeth to be restored should be symptomless and vital.
Teeth to be restored have antagonist teeth.
Teeth should have class 2 caries lesion with ICDAS score 3/ 4/5. |
|
| ExclusionCriteria |
| Details |
Xerostomia and bruxism.
Absence of adjacent and antagonist teeth.
Extremely poor oral hygiene.
Pregnant or lactating women.
Teeth that have any restorations, endodontic treatment.
The patients undergoing orthodontic treatment.
Mobile 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 |
| retention,colour match,marginal discoloration,secondary caries,wear,marginal adaptation. |
6months,12months |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
14/09/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/09/2023 |
| 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
|
Comparitive evaluation of bulk fill and self adhering composites with USPHS Criteria , a one year follow up study using the sectional matrix system |