| CTRI Number |
CTRI/2025/05/086504 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying how a single-shade tooth-colored filling blends with natural teeth and if it causes discoloration at the edges. A Clinical trial |
|
Scientific Title of Study
|
Evaluation of the optical behaviour and marginal discoloration of a single shade resin composite with a chameleon effect - A Randomized clinical 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 BHARGAV PATEL |
| Designation |
PG Student |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
2nd Floor, Department of Conservative Dentistry and Endodontics,Government Dental College and Hospital, Pathikashram Road,Navagam Ghed
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9726695218 |
| Fax |
|
| Email |
bhargav.patel8328@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Leena Jobanputra |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
Department of Conservative Dentistry and Endodontics, Pathikashram Main road, Navagam, Jamnagar, Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9879503545 |
| Fax |
|
| Email |
lihiren@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Leena Jobanputra |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
Department of Conservative Dentistry and Endodontics, Pathikashram Main road, Navagam, Jamnagar, Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9879503545 |
| Fax |
|
| Email |
lihiren@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Jamnagar, Pathikashram Main Road, Navagam, Jamnagar, Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Dr BHARGAV PATEL |
| Address |
2nd Floor, Department of Conservative Dentistry and Endodontics,Government Dental College and Hospital,pathikashram Road,Navagam Ghed,Jamnagar Gujarat 361008 |
| 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 Bhargav Patel |
Government Dental College and Hospital, Jamnagar |
203, second floor, Department of Conservative Dentistry and Endodontics
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
9726695218
bhargav.patel8328@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, M.P. Shah Medical College and Guru Gobind Singh Hospital, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental Caries
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Class 1 control cavity Restoration with tetric n ceram resin composite |
After class 1 tooth preparation cavity etching with 37% phosphoric acid followed by bonding agent- 8th generation -followed by curing with blue phase curing light, restoration with increment wise tetric n ceram resin composite |
| Intervention |
Class 1 test cavity Restoration with omnichroma single shade composite |
After class 1 tooth preparation cavity etching with 37% phosphoric acid followed by bonding agent- 8th generation -followed by curing with blue phase curing light, restoration with tokuyama omnihroma single shade resin composite |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.The Age group of 18-45 years with excellent systemic health condition.
2.At least two molar or premolars with occlusal carious lesions where the size of the cavity was less than one-third of the inter- cuspal distance.
3.Absence of any signs of fistula, pulp exposure, periodontal tissue swelling or abnormal tooth mobility as determined by radiographs or clinical examination.
4.Patients who can maintain good oral hygiene.
5.Patients who consented to come for follow-up.
|
|
| ExclusionCriteria |
| Details |
1.Poor oral hygiene, recession, alveolar bone loss.
2.Heavy smokers, parafunctional habits such as bruxism or traumatic occlusion.
3.Natural opposing teeth with existing restorations.
4.Teeth with very deep carious lesion.
5.Patient taking antibiotic medications within the last 1 Week or the use of analgesics.
6.Medically compromised patients, pregnant women and therapeutic radiation to the head and neck region.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| USPHS CRITERIA, COLOR MATCHING |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| COLOR MATCHING |
1 year |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
16/06/2025 |
| 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
|
This study involves 35 patients, each receiving two Class I posterior composite restorations using a split-mouth design. One side will be treated with Omnichroma composite (test group), and the other with Tetric-N-Ceram (control group). A total of 70 cavities will be evaluated. Standard clinical procedures, including case history, radiographic and vitality assessments, and shade selection (for control group), will be performed. Cavities will be prepared, etched, bonded, and filled with designated materials using layered techniques. Restorations will be finished, and after 24 hours of rehydration, color match and stability will be assessed by three blinded evaluators using USPHS criteria and magnification tools. |