| CTRI Number |
CTRI/2025/03/082887 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between palodent and dual force sectional matrix system for proximal contact tightness of class II composite restorations |
|
Scientific Title of Study
|
Comparative evaluation of palodent and dual force sectional matrix systems on proximal contact tightness of class II composite restorations in adult human permanent molars- A randomised controlled 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 Karan Akude |
| Designation |
PG student |
| Affiliation |
Bharti vidyapeeth dental college and hospital, Navi mumbai |
| Address |
Room no 302, 3rd floor, Department of conservative dentistry and endodontics, Bharti vidyapeeth dental college and hospital, Sector 7 CBD belapur, Navi mumbai
Mumbai MAHARASHTRA 400614 India |
| Phone |
08329015699 |
| Fax |
|
| Email |
karanakude.98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashish Jain |
| Designation |
Head of Department |
| Affiliation |
Bharti vidyapeeth dental college and hospital, Navi mumbai |
| Address |
Room no 302, 3rd floor, Department of conservative dentistry and endodontics, Bharti vidyapeeth dental college and hospital, Sector 7 CBD belapur, Navi mumbai
Mumbai MAHARASHTRA 400614 India |
| Phone |
9869152905 |
| Fax |
|
| Email |
drakjain5@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ashish Jain |
| Designation |
Head of Department |
| Affiliation |
Bharti vidyapeeth dental college and hospital, Navi mumbai |
| Address |
Room no 302, 3rd floor, Department of conservative dentistry and endodontics, Bharti vidyapeeth dental college and hospital, Sector 7 CBD belapur, Navi mumbai
Mumbai MAHARASHTRA 400614 India |
| Phone |
9869152905 |
| Fax |
|
| Email |
drakjain5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Karan Akude
Room no 302, 3rd floor, Bharti vidyapeeth dental college and hospital, sector 7, CBD belapur, Navi mumbai 400614 |
|
|
Primary Sponsor
|
| Name |
Dr Karan Akude |
| Address |
Department of Conservative dentistry and endodontics, Bharti vidyapeeth dental college and hospital, Sector 7, CBD Belapur, Navi mumbai |
| 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 Karan Akude |
Bharati Vidyapeeth Dental College and Hospital |
Room no 302, 3rd floor, Department of conservative dentistry and endodontics, Bharti vidyapeeth dental college and hospital, Sector 7 CBD belapur, Navi mumbai Mumbai MAHARASHTRA |
8329015699
karanakude.98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for biomedical and health research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Class II caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dual Force Sectional Matrix System |
Dual force sectional matrix system is a new type of system which claims to provide tight proximal contact in class II composite restorations. Dual force sectional matrix system will be adapted to restore class II composite restorations and after 7 days, contact tightness score will be recorded |
| Comparator Agent |
Palodent Sectional Matrix System |
Palodent sectional matrix system will be adapted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Cooperative healthy patients who are willing to participate in the study and sign the consent form.
2. ICDAS score of 3,4, and 5 (clinically).
3. ICDAS score of RA2, RA3, RB4 (radiographically).
4. Patients in the age group of 18-50 years.
5. Fully erupted first and second molars in maxillary and mandibular arch.
|
|
| ExclusionCriteria |
| Details |
1. Diastema between posterior teeth.
2. Presence of fixed partial dentures.
3. Mobile teeth.
4. Grossly carious teeth.
5. Patients with Gingivitis and periodontitis.
6. Caries involving disto-occlusal surface of second molars in patients with absence of third molars.
7. In cases where isolation cannot be achieved.
8. Patients with high caries index.
|
|
|
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 |
| Proximal contact tightness score |
Proximal contact tightness score
after 7 days of restoration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
17/04/2025 |
| 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="0" Months="4" 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
crucial component of the masticatory system is the proximal contact.
Inappropriate contact can result in periodontal disorders and food impaction.
· During
amalgam restorations, condensation of amalgam creates tight proximal contact, but
when placing direct posterior composite restorations, it might be challenging
to establish tight proximal contact.
· One
of the primary motivations for creating high viscosity composites, or ceromers,
was the belief that applying pressure to the composite resin material would
have the same result.
· However,
because of the visco-elastic nature of composite resin materials, in vitro
investigations demonstrate that packing high-viscous composites does not
contribute to a tight proximal contact.
·
Therefore,
the knowledge and functioning of good matrix systems for class II composite
restorations is imperative to achieve good proximal contacts.
· Although
widely utilised in dentistry, traditional circumferential matrix system has
limitations when it comes to forming tight proximal contact. In light of this,
new alternative matrix systems have been introduced in market.
· Sectional
matrix methods combined with separation rings have been shown in recent in
vitro and in vivo experiments to produce proximal contact with a good tightness
in class II restoration.
· The Palodent sectional matrix system is
considered gold standard in restoring class II composite
restorations until now. However, newer sectional matrix system like Dual Force
claims to achieve tighter contacts with clinically and technologically advanced
rings, active wedges and ultra-wrap matrix bands.
·
To
best of our knowledge, no study was conducted to investigate proximal contact
tightness of class II composite restorations in adult permanent molars with
Palodent and Dual Force sectional matrix systems.
· Therefore, the objective of our randomised controlled
trial is to compare proximal contact tightness of class II composite
restorations in adult human permanent molars using Palodent and Dual Force
sectional matrix system. |