| CTRI Number |
CTRI/2026/01/100382 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study comparing the contact and shape of tooth fillings made using three different matrix systems in back teeth. |
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Scientific Title of Study
|
Comparative Clinical Assessment of Proximal Contacts and Contours in Class II Posterior Restorations Using Three Matrix Systems: Randomised Clinical Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meenu Goyat |
| Designation |
Post Graduate |
| Affiliation |
Manipal College of Dental Science |
| Address |
Department of conservative dentistry and endodontics, room no .3,Kasturba Medical College, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8968218266 |
| Fax |
|
| Email |
meenugoyat17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Vinod rakesh jathanna |
| Designation |
associate professor |
| Affiliation |
Manipal College of Dental Science |
| Address |
Department of conservative dentistry and endodontics, room no.3,Kasturba Medical College, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8968218266 |
| Fax |
|
| Email |
vinod.jathanna@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Meenu Goyat |
| Designation |
Post Graduate |
| Affiliation |
Manipal College of Dental Science |
| Address |
Kasturba Medical College, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8968218266 |
| Fax |
|
| Email |
meenugoyat17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Science |
|
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Primary Sponsor
|
| Name |
Manipal College of Dental Science,Mangalore |
| Address |
Kasturba Medical College, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka 575001 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrMeenu Goyat |
Manipal College of Dental Science |
Department of conservative dentistry and endodontics, room no.3,Kasturba Medical College, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka,575001
Dakshina Kannada
KARNATAKA |
8968218266
meenugoyat17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,MCODS,Mangalore. |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tofflemire, Palodent V3, and Saddle Matrix Systems |
Standardized Class II cavities will be restored using composite resin under rubber dam isolation. Participants will be randomly assigned to Tofflemire, Palodent V3, or Saddle matrix systems. All restorations follow identical etching, bonding, incremental composite placement, and polishing protocols. Outcomes: proximal contact and contour (FDI criteria) and radiographic overhangs. |
| Comparator Agent |
Tofflemire circumferential matrix system |
Conventional circumferential Tofflemire matrix with wooden wedge and burnishing will serve as the control. Restorations will follow the same etching, bonding, composite placement, and polishing protocol as other groups. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
Participants will be eligible if
1.they are aged 18 years or older,
2.have fully erupted and occluding permanent posterior teeth with proximal contact present with compound Class II (MO or DO) 3.supragingival lesions involving one third or less of the intercuspal distance. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
Participants will be excluded if they:
1• Have complex Class II lesions, crowding/spacing, or tooth mobility
2• Present with periodontal disease
3• Have deep cavities or pulp involvement
4• Have previously restored adjacent proximal surfaces
5• Lack contact with the adjacent tooth
6.Do not provide informed consent
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Method of Generating Random Sequence
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Permuted block randomization, fixed |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1• Proximal contact tightness will be assessed using FDI criteria via the dental floss test and categorised as optimum, tight or open.
2• Radiographic evaluation of overhangs will be conducted using bitewing radiographs and classified as absent, positive or negative.
|
at baseline |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 1. The study will evaluate differences among the three matrix systems in terms of proximal contour accuracy(FDI .criteria), radiographic overhang formation,operator handling/ease of placement & patient comfort with floss passage & food impaction. |
Immediately post-restoration (single visit). |
|
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Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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 1 |
|
Date of First Enrollment (India)
|
16/01/2026 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Introduction:
Achieving proper proximal contact and contour in Class II composite restorations is essential for maintaining tooth stability and preventing food impaction. Composite resin materials and matrix design influence the final proximal contact quality. Traditional circumferential matrices often result in open contacts, whereas sectional and saddle matrices provide better separation and contour. This study aims to compare proximal contact tightness and contour accuracy using Tofflemire, Palodent V3, and Saddle matrix systems based on FDI criteria. Objectives:
Primary objective: To compare proximal contact tightness and proximal contour quality using the three matrix systems.
Secondary objective: To assess radiographic overhang formation among the three systems. Methods:
Trial design: Parallel arm randomized clinical trial with three groups.
Setting: Department of Conservative Dentistry and Endodontics, MCODS, Mangalore.
Participants: Adults aged 18 years and above with supragingival Class II lesions limited to one third intercuspal distance. Teeth must have an adjacent natural tooth with a contact point. Exclusion criteria include deep lesions, tooth mobility, periodontal disease, spacing, crowding, or existing adjacent restorations. Interventions:
Group 1: Tofflemire matrix system.
Group 2: Palodent V3 sectional matrix system.
Group 3: Saddle matrix system.
All teeth will be isolated using a rubber dam, prepared using standardized cavity procedures, bonded using total etch technique, restored with composite resin in increments, and finished and polished. Outcome Measures:
Primary outcomes include proximal contact tightness assessed by floss test and clinical FDI criteria, and radiographic presence of overhangs. Secondary outcomes include proximal contour accuracy and procedure-related ease. FDI Contact Criteria:
Optimum contact: Slight resistance.
Tight contact: Hard to pass floss.
Open contact: No resistance. Sample Size:
Twenty-one participants, seven per group. Randomization:
Block randomization with sequentially numbered opaque envelopes. Blinding:
Outcome assessor blinded. Operator and participants not blinded. Statistical Analysis:
Chi square test with significance at p less than 0.05. Ethics and Dissemination:
Ethics committee approval will be obtained. Data confidentiality will be maintained. Results will be shared through publications and scientific presentations.
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