| CTRI Number |
CTRI/2024/06/069365 [Registered on: 21/06/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
study for checking clinical evaluation and patient acceptance by using three different matrix system for class II restoration in primary molars. |
|
Scientific Title of Study
|
Comparative analysis of clinical efficacy and patient acceptance using three different matrix systems for class II restoration in primary molars . |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayyanki Mounika |
| Designation |
Post graduate |
| Affiliation |
SRI SAI COLLEGE OF DENTAL SURGERY |
| Address |
Department of Pediatric and Preventive Dentistry Room No 9
1-2-64/1 and 2,kothrepally,opposite shiv sagar lake,Vikarabad,Telangana-501102 India
Hyderabad TELANGANA 501102 India |
| Phone |
7989582819 |
| Fax |
|
| Email |
ayyankimounika07@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr ziauddin mohammad |
| Designation |
PROFESSOR |
| Affiliation |
SRI SAI COLLEGE OF DENTAL SURGERY |
| Address |
Department of Pediatric and Preventive Dentistry Room No 9
1-2-64/1 and 2,kothrepally,opposite shiv sagar lake,Vikarabad,Telangana-501102 India
Hyderabad TELANGANA 501102 India |
| Phone |
9885998842 |
| Fax |
|
| Email |
drziamohammad@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr ziauddin mohammad |
| Designation |
PROFESSOR |
| Affiliation |
SRI SAI COLLEGE OF DENTAL SURGERY |
| Address |
Department of Pediatric and Preventive Dentistry Room No 9
1-2-64/1 and 2,kothrepally,opposite shiv sagar ,Vikarabad ,Telangana .
Hyderabad TELANGANA 501102 India |
| Phone |
9885998842 |
| Fax |
|
| Email |
drziamohammad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sai College of Dental Surgery,
Department of Pediatric and Preventive Dentistry, Room No 9,
1-2-64/1 and 2,kothrepally,opposite shiv sagar lake,Vikarabad,Telangana-501102 India |
|
|
Primary Sponsor
|
| Name |
Ayyanki mounika |
| Address |
Sri Sai College Of Dental Surgery
Department Of Pediatric And Preventive Dentistry Room No 9,
1-2-64/1&2,kothrepally,opposite shiv sagar lake,Vikarabad,Telangana -501102 India. |
| 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 Ayyanki Mounika |
SRI SAI COLLEGE OF DENTAL SURGERY |
Department of Pediatric And Preventive Dentistry Room no.9,1-2-64/1&2,kothrepally ,opposite shiv sagar lake , Vikarabad, Telangana 501102 Hyderabad
Telangana . Hyderabad TELANGANA |
7989582819
ayyankimounika07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE 2023-24 |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Restoring Class II With MODIFIED T -BAND |
Comparing clinical efficacy of restoration before and after using Modified T -BAND for class 2 preparation with aid of radiographic examination . |
| Intervention |
Restoring Class II With PRO MATRIX -CURVE |
Comparing clinical efficacy of restoration before and after using Pro matrix - curve for class 2 preparation with aid of radiographic examination |
| Intervention |
Restoring class II With T BAND
|
Comparing clinical efficacy of restoration before and after using T band for class 2 preparation with aid of radiographic examination |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children with class II caries limited to enamel or dentin and presence of adjacent teeth are included in the study.
No history of pain or swelling.
Children with positive and definitely positive behaviour are included in the study.
Both maxillary and mandibular primary first and second molars are included .
Proximal surfaces - DO of primary first molars and MO of primary second molars are included .
|
|
| ExclusionCriteria |
| Details |
Teeth with pre shedding mobility.
Extensively damaged teeth.
Children with partially or ectopically erupted primary molars.
Children with known systemic disorders. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of conventional T-band , modified T-band and (PRO MATRIX) Curve band on clinical and patient acceptance in restoration of class II cavity . |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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 |
|
Date of First Enrollment (India)
|
05/08/2024 |
| 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="7" 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
|
Primary teeth play a crucial role in mastication, speech development, and maintaining space for permanent dentition. Class II cavities, involving proximal surfaces, are one of the most common types of dental caries in primary dentition. The restoration of these cavities is essential to prevent further decay, maintain tooth function, preserve the arch length and promote oral health. Matrix bands are essential tools in class II restorations, providing support and shaping during placement of restorative material. However, achieving optimal contact points remains challenging, as inadequate contacts can lead to issues such as food impaction, periodontal problems, and tooth movement. These matrix systems are particularly useful for restoring cavities with missing proximal walls. The primary purpose of a matrix band is to compensate for missing walls and contain filling material. As matrix band systems have evolved, newer designs aim to improve usability and address shortcomings of older systems. Conventional T-band placement has been a longstanding technique in pediatric dentistry for restoring class II cavities. It involves the use of metal bands to achieve proper isolation and adaptation during the restoration process. However, this technique may have limitations. The modified design allows for better adaptation to the tooth surface, resulting in improved marginal seal and reduced risk of micro leakage. The modified T-band design provides increased stability during restoration procedures, minimizing the likelihood of displacement or movement during placement of restorative materials. In recent years, the (PRO MATRIX) Curve band system has gained popularity as an alternative to conventional T-bands. This system utilizes a flexible, contoured matrix that adapts closely to the tooth anatomy, providing improved isolation and contouring for composite restorations. (PRO MATRIX) Curve band aims to simplify the restoration process. |