| CTRI Number |
CTRI/2025/09/095244 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Two Types of Tooth-Colored Filling materials in the teeth of Children |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical Performance of Universal versus Conventional Composite Resin Restoration in Primary Molars-A Split mouth 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 Koya Naga Venkata Siva Kumari |
| Designation |
First Year Post Graduate |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Pedodontics and Preventive Dentistry, Second Floor, Block - III, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh - 534202
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9014525472 |
| Fax |
|
| Email |
sivakumari.koya1707@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Penmatsa Chaitanya |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Pedodontics, Vishnu Dental College,
Bhimavaram,
West Godavari District,
Andhra Pradesh - 534202
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9909217142 |
| Fax |
|
| Email |
drchaitanyamds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Penmatsa Chaitanya |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Pedodontics, Vishnu Dental College,
Bhimavaram,
West Godavari District,
Andhra Pradesh - 534202
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9909217142 |
| Fax |
|
| Email |
drchaitanyamds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College,
Bhimavaram,
West Godavari District,
Andhra Pradesh - 534202 |
|
|
Primary Sponsor
|
| Name |
Dr Koya Naga Venkata Siva Kumari |
| Address |
Department of Pedodontics and Preventive Dentistry, Second Floor, Block - III, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh - 534202 |
| 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 Koya Naga Venkata Siva Kumari |
Vishnu Dental College |
Department of Pedodontics and Preventive Dentistry, Second Floor, Block - III, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh - 534202
West Godavari
ANDHRA PRADESH |
9014525472
sivakumari.koya1707@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instutional Ethics Committee Vishnu Dental College |
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 |
Between Omnichroma and Tetric-N-Ceram |
Using a Split -Mouth Design Primary Molar on one side of the arch will be restored with Omnichroma and molar on other side of arch with Tetric-N-Ceram |
| Intervention |
Restoration in Primary Molar |
Caries involving Pit and Fissures in Primary Molars |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Primary molars with occlusal caries in 4-9 years old children.
2.Co-operative children.
3.Children who are willing to be a part of the study.
|
|
| ExclusionCriteria |
| Details |
1.Medically compromised patient.
2.Teeth with development defects.
3.Teeth that are unrestorable.
4.Teeth with signs and symptoms of pain or swelling.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical Performance of Restorative Material using USPHS criteria. |
6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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)
|
06/10/2025 |
| 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="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-split Mouth design to evaluate the clinical performance of Universal Composite and Conventional Composite resin Restoration in occlusal carious primary molars among 4-9 yr old children. Children coming to out patient block in Department of Pedodontics and Preventive Dentistry will be recruited and screened. Based on inclusion and exclusion criteria ,4-9 years old children (n=43), with occlusal caries in primary molars. Written informed consent will be obtained from parents. using computer generated sequence random allocation of teeth will be done and divided into 2 groups .Group-1 Omnichroma n=(43) and Grop-2 Tetric-N-Ceram n =(43). Caries excavation will be done using high speed airotor handpiece and BR-45 round bur. Isolation will be done using cotton rolls and high volume suction device .Acid Etching for 15 seconds will be carried out with 37 % phosphoric acid then rinsed with water for a minute and dried. Application of bonding agent will be done and light cured for 20 seconds. The cavity will be restored with composite material and light cured for 20 seconds. Post operative occlusal evaluation will be done using articulating paper. Fine adjustments will be made if required using finishing bur. Clinical performance of restoration will be evaluated at 6 and 12 months using modified USPHS criteria and scored as alpha, bravo ,Charlie for the following parameters which include Color stability, Marginal adaptation ,Secondary caries ,Post operative sensitivity ,Retention, Anatomical form. |