| CTRI Number |
CTRI/2025/07/090282 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study comparing how well two tools help fill gaps between teeth during dental fillings |
|
Scientific Title of Study
|
Comparative Evaluation of Proximal Contact Tightness in Class II Composite Resin Restoration Using Two Different Matrices: An In-Vivo Study |
| 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. Aditi Surana |
| Designation |
Post Graduate Trainee |
| Affiliation |
GNIDSR, KOLKATA |
| Address |
2nd floor, Dept of Conservative Dentistry and Endodontics, GNIDSR
157/F, Nilgunj Rd, Sahid Colony, Panihati, Kolkata, Khardaha, West Bengal 700114
North Twentyfour Parganas WEST BENGAL 700114 India |
| Phone |
09836071782 |
| Fax |
|
| Email |
aditisurana1998@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr. Priti D Desai |
| Designation |
Professor |
| Affiliation |
GNIDSR, KOLKATA |
| Address |
2nd floor, Department of Conservative Dentistry and Endodontics, GNIDSR
157/F, Nilgunj Rd, Sahid Colony, Panihati, Kolkata, Khardaha, West Bengal 700114
North Twentyfour Parganas WEST BENGAL 700114 India |
| Phone |
9831071362 |
| Fax |
|
| Email |
priti.desai@gnidsr.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr. Aditi Surana |
| Designation |
Post Graduate Trainee |
| Affiliation |
GNIDSR, KOLKATA |
| Address |
2nd floor, Dept of Conservative Dentistry and Endodontics, GNIDSR
157/F, Nilgunj Rd, Sahid Colony, Panihati, Kolkata, Khardaha, West Bengal 700114
North Twentyfour Parganas WEST BENGAL 700114 India |
| Phone |
09836071782 |
| Fax |
|
| Email |
aditisurana1998@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aditi Surana |
| Address |
Anand kunj building, flat 1c
17/2A Burdwan ROAD, Alipore, Kolkata, West bengal
pin code: 700027 |
| Type of Sponsor |
Other [Post graduate trainee] |
|
|
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 Aditi Surana |
Guru Nanak Institute of Dental Sciences and Research |
2nd floor, Dept of Conservative Dentistry and Endodontics, GNIDSR
157/F, Nilgunj Rd, Sahid Colony, Panihati, Kolkata, Khardaha, West Bengal 700114 North Twentyfour Parganas WEST BENGAL |
09836071782
aditisurana1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Guru Nanak Institute of Dental Sciences and Research Panihati, Kolkata 700114 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bioclear matrix |
For class II Carious restoration in posterior teeth, application of the Bioclear matrix system will be done. Using Bioclear forceps, twin ring with clear anatomically shaped mylar matrices will be applied and diamond wedge will be used to stabilize it in position
after which the restoration will be done.
After the restoration is completed, the bioclear matrix will be removed from the tooth on which it was applied following which the evaluation of proximal contact tightness will be done with three methods immediately with digital force gauge, dental floss, and IOPA Radiograph.
The interventional agent i.e. the bioclear matrix , will be placed onto the tooth for as long as the restoration is completed, which typically takes around 15 minutes. |
| Comparator Agent |
Sectional Matrix system |
For class II Carious restoration in posterior teeth, application of the Sectional matrix system will done. Sectional matrix retainer and ring will be applied. Here, plastic wedge will be used to stabilize it in position, after which the restoration will be done.
After the restoration is completed, evaluation of proximal contact tightness will be done with three methods immediately with digital force gauge, dental floss, and IOPA Radiograph
the comparator agent i.e. the sentional matrix used for the composite resin restoration in this group, will be placed onto the tooth until the restoration is completed, which takes around 10 minutes, after which it will be removed and the readings will be taken for evaluation of proximal contact tightness. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Class II carious lesion in posterior teeth ( 1st and 2nd premolars and molars) will be considered
2. Class II carious lesion with either mesial or distal or MOD (all will be included in this study)
3. Any Proximal lesions either Mesial, Distal, or MOD Lesions extending below the free gingival margin.
|
|
| ExclusionCriteria |
| Details |
1. Teeth with morphological variation
2. Severely damaged tooth
3. Tooth with severe attrition
4. Teeth with no adjacent tooth
5. Teeth with mobility
6. Teeth with poor periodontal health
7. Teeth with plunger cusps
8. Large carious lesion approaching pulp
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In the present study, proximal contact tightness will be measured in both groups and natural tooth will be recorded by using digital force gauge, waxed dental floss and digital radiograph. So, the expected outcome will be variations in evaluation by various methods and comparison amongst them. |
The evaluation of proximal contact tightness will be done at baseline after the restoration is completed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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)
|
09/09/2025 |
| 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)
Modification(s)
|
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
|
Maintaining proximal contact in dentition is a fundamental aspect of restorative dentistry that significantly influences oral health and longevity of dental restorations. Proximal contact refers to the relationship between adjacent teeth at their interproximal surfaces, playing a critical role in preventing food impaction, ensuring proper alignment, and supporting periodontal health. Failure to obtain tight proximal contacts can cause food impaction, resulting in caries or periodontal disease and possible movement of teeth. Therefore, effective management of these contacts is essential for aesthetic reasons and the functional stability of dental restorations. When restoring the proximal contact, the reconstruction of correct anatomical contour as well as the provision of appropriate proximal contact tightness is essential for periodontal health. Research work by Osborn and Dörfer et al,1961 laid the groundwork for understanding the importance of interproximal relationships in restorative dentistry and highlighted the need for precision during the restoration process. Their studies provided insights into the relationships between restoration materials, techniques, and the effectiveness of achieving optimal proximal contacts. They found that factors such as the type of material used, placement techniques, and the design of the restoration significantly influenced the quality of proximal contacts. To achieve proper proximal contact in direct composite resin restorations, the clinical procedure must compensate for the thickness of the matrix as well as the polymerization shrinkage of the composite resin. Both proximal contact tightness, PCT and proximal contours are two key factors that are related to the establishment of proximal surface. The PCT is regarded to be of a dynamic nature that could be influenced by the type, location and size of the tooth, the position of the patient on the dental chair being supine or upright, the degree of the mouth opening, accessibility to the region, restorative techniques, and the masticatory forces. At different times in one day, PCT has been shown to differ with the periodontal ligament’s fatigue and alterations in viscoelastic characteristics owing to the potential role of circadian rhythms. For placement of the composite resin, varied measures have already been made to sustain the anatomical structure of proximal contact area. Special instruments were utilized to achieve the optimal proximal contour such as diverse matrix systems, separation rings and wedges. There are many different types of matrix systems in the market specifically designed to be utilized with composite resin. To check PCT in this study, one of the methods used is a digital force gauge.The system used a 0.05-mm-thick metal strip inserted interdentally from an occlusal direction. The metal strip was connected to the digital force gauge. The tightness of the proximal contact was quantified as the maximum frictional force when the strip was slowly removed in a buccal-lingual direction. The maximum force was recorded on the screen of the gauge for each measurement when the gauge was switched to peak mode and the tightness was measured. The second method used for evaluation of PCT is by passing waxed floss between two teeth, but it is difficult to detect the proximal contact tightness by this method because this is a very subjective method rather than qualitative. The scoring criteria given by Dörfer et al(2001) is commonly used. Score 1 Open contact,when there is visible space between the two teeth. Score 2 is known as Optimum contact, when passing the floss requires some amount of pressure to pass through. Score 3 is tight contact: when the floss requires maximum pressure and does not pass through easily. The third method of evaluation is by radiograph analysis by observing presence of gaps or not. |