| CTRI Number |
CTRI/2026/03/106337 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing Two Different Materials For Front Tooth Repairs To See Which One Looks Better And Lasts Longer. |
|
Scientific Title of Study
|
Comparative Evaluation Of Colour Matching And Stability Of Two Commercially Available Composite Resin As Direct Veneer In Maxillary Anterior Teeth - 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 |
Thakshak N |
| Designation |
UG Student (CRRI) |
| Affiliation |
SRM Kattankulathur Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics,
SRM Kattankulathur Dental College and Hospital,
Tamil Nadu – 603203, India.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
6382645529 |
| Fax |
|
| Email |
thakshak14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thakshak N |
| Designation |
UG Student (CRRI) |
| Affiliation |
SRM Kattankulathur Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics,
SRM Kattankulathur Dental College and Hospital,
Tamil Nadu – 603203, India.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
6382645529 |
| Fax |
|
| Email |
thakshak14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Thakshak N |
| Designation |
UG Student (CRRI) |
| Affiliation |
SRM Kattankulathur Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics,
SRM Kattankulathur Dental College and Hospital,
Tamil Nadu – 603203, India.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
6382645529 |
| Fax |
|
| Email |
thakshak14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chancellor Research Fellowship
SRM Medical College Hospital And Research Centre
SRM Nagar, Potheri, Chengalpattu
Tamil Nadu - 603203
India |
|
|
Primary Sponsor
|
| Name |
SRM Kattankulathur Dental College |
| Address |
SRM Nagar
Potheri, Chengalpattu
Tamil Nadu, 603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 S Aravinthan |
SRM Kattankulathur Dental College and Hospital |
Room No 105, Clinical Block
Department of Conservative Dentistry and Endodontics
Kancheepuram
TAMIL NADU |
9095370301
aravints1@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Multi-shade composite |
Direct composite veneer restoration using a multi-shade universal composite (Neo Spectra ST) in maxillary anterior teeth applied, following minimal tooth reduction and standard adhesive protocols |
| Intervention |
Single-shade composite |
Direct composite veneer restoration using a single shade universal composite (Omnichroma) in maxillary anterior teeth applied, following minimal tooth reduction and standard adhesive protocols |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Vital teeth
No prior restorations on the tooth and adjacent tooth
Good oral hygiene
Patients requiring veneer restorations in maxillary anterior teeth due to
Uncomplicated crown fracture
Mild to moderate fluorosis
Spacing in anterior teeth
Peg laterals
|
|
| ExclusionCriteria |
| Details |
Non vital teeth
Teeth with severe discoloration
Patients with bruxism or para functional habits or restorations in adjacent teeth
Severe periodontal disease
Patients with multiple carious lesion
Patients with attrition or abrasion or abfraction
Patient not signing consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Initial shade matching outcome measured using a spectrophotometer to obtain (Delta E) values |
7 days and 1 month post-restoration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical evaluation of color stability using a spectrophotometer ((Delta E) values) |
3 months, 6 months and 12 months |
| Subjective visual shade match score provided by blinded evaluators |
1 week, 3 months, 6 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/03/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Title: Comparative Evaluation Of Colour Matching And Stability Of Two Commercially Available Composite Resin As Direct Veneer In Maxillary Anterior Teeth - A Randomized Clinical Trial
Background: Patients increasingly seek aesthetic restorations that blend naturally with their teeth. Direct veneers are a common solution for correcting discoloration, spacing, and minor fractures.
Primary purpose: Clinical evaluation and comparison of colour matching capability and colour stability of two commercially available composite resin systems — a single-shade composite (Omni Chroma, Tokuyama) and a multi-shade composite (Neo Spectra ST, Dentsply) when used as direct veneers for maxillary anterior teeth.
Study Hypothesis: The null hypothesis for this study is that there will be no significant difference in the color matching and color stability between the single-shade and multi-shade composite resin systems. Conversely, the alternate hypothesis is that a significant difference will exist between the two materials.
Methodology: This is a double-blinded randomized clinical trial involving 50 restorations in patients aged 18 to 40 years. Participants requiring veneers in maxillary anterior teeth due to crown fractures, mild fluorosis, spacing, or peg laterals are included. The sample is divided into two groups:
Group I: Single-shade composite (Omni Chroma, Tokuyama).
Group II: Multi-shade composite (Neo Spectra ST, Dentsply).
Evaluation and Follow-up: The initial shade matching will be evaluated using a spectrophotometer to record Delta E values and a visual shade match score by blinded evaluators. Colour stability will be compared during follow-up visits at 3 months, 6 months, and 12 months. The study seeks to determine if technological advancements in single-shade composites translate to superior clinical performance and longevity compared to traditional multi-shade systems.
|