| CTRI Number |
CTRI/2026/02/104174 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing Contact and Shape of Children’s Back Teeth Fillings Using Different Dental tools |
|
Scientific Title of Study
|
Clinical And Radiographic assessment of proximal contacts and contours in class II restorations of primary molars using different matrix systems-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 |
DrVenigalla Susmitha |
| Designation |
First Year Post graduate |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no : 7,Department of Pediatric and preventive dentistry,Sibar Institute of Dental Sciences ,Takkellapadu,Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9059526731 |
| Fax |
|
| Email |
susmithavenigalla2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAvula Jogendra Sai Sankar |
| Designation |
Professor & Head |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no : 7,Department of Pediatric and preventive dentistry,Sibar Institute of Dental Sciences ,Takkellapadu,Guntur
Guntur
ANDHRA PRADESH
522509
India ,Takkellapadu,Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9346550646 |
| Fax |
|
| Email |
saisamata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVenigalla Susmitha |
| Designation |
First Year Post graduate |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no : 7,Department of Pediatric and preventive dentistry,Sibar Institute of Dental Sciences ,Takkellapadu,Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9059526731 |
| Fax |
|
| Email |
susmithavenigalla2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar Institute of Dental Sciences, Takkellapadu,Guntur, Andhra Pradesh, India - 522509 |
|
|
Primary Sponsor
|
| Name |
Dr.Venigalla Susmitha |
| Address |
Door no-8-198, Near Sachivalayam, Veerapuram,Piduguralla,Palnadu district ,Andhra Pradesh,522437 |
| 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 |
| DrVenigalla Susmitha |
Sibar Institute of Dental Sciences |
Room no : 7,Department of Pediatric and preventive dentistry
Guntur
ANDHRA PRADESH |
9059526731
susmithavenigalla2017@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sibar Institute of Dental Sciences,Guntur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Circumferential Tofflemire matrix system
2.TOR VM sectional matrix system
3.Unimatrix sectional matrix system |
Following class II cavity preparations in primary molars, each group will receive respective matrix systems. The restorations will be performed using class 9 glass ionomer cement. Post operatively the proximal contacts will be assessed clinically and contours will be assessed radiographically |
| Comparator Agent |
Circumferential Tofflemire matrix system |
Circumferential Tofflemire matrix system will be compared to TOR VM Sectional matrix and Unimatrix sectional matrix systems |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Deciduous molars in children aged 5-9 years with Class II supragingival cavities that involves marginal ridge.
Deciduous 1st molar with disto - occlusal cavity or 2nd molar with mesio - occlusal cavity.
Parent who have given consent to be part of the study
Subject who have given assent to be part of the study.
Availability of adjacent teeth for contact .
|
|
| ExclusionCriteria |
| Details |
Extensively damaged teeth.
Lesions extending below gingiva and without an adjacent tooth.
Teeth with pre-shedding mobility.
Uncooperative subjects.
Pulpally involved teeth.
Medically compromised subject.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
PROXIMAL CONTACTS(Clinical)
1.Optimum contacts - If dental floss could be passed with either little resistance or resistance equal to that of the natural teeth on the opposing side
2.Tight contacts - If dental floss was unable to pass at all or shredded
3.Open contacts - If the dental floss passes without any resistance |
Immediately after placing restoration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PROXIMAL CONTOURS(Radiographic)
1.Undercontour - Presence of undercontour in the region corresponding to the gingival wall
2.Overcontour - Presence of overcontour in the region corresponding to the gingival wall. |
Immediately after placing restoration |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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 4 |
|
Date of First Enrollment (India)
|
10/03/2026 |
| 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 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
|
This in vivo study involves the selection of primary molars based on
defined inclusion and exclusion criteria. Pre-operative periapical radiographs
are taken to assess the extent of caries, followed by Class II cavity
preparation. The teeth are randomly allocated into three groups based on the
matrix system used: Group I receives a circumferential Tofflemire matrix, Group II receives a TOR VM sectional contoured metal matrix, and Group III receives a Unimatrix
sectional metal matrix . After
isolation and pulpal protection, all cavities are restored with class 9 glass ionomer cement. Post-restoration finishing and polishing are performed,
followed by application of petroleum jelly and acquisition of standardized
postoperative bitewing radiographs. Proximal contacts are evaluated clinically
using dental floss according to FDI-based criteria, while proximal contours are
assessed radiographically using established criteria. Assessments are carried
out by the primary investigator, with random verification by a second
investigator to ensure reliability. |