| CTRI Number |
CTRI/2020/11/029420 [Registered on: 27/11/2020] Trial Registered Prospectively |
| Last Modified On: |
31/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
contact evaluation of two matrix systems |
|
Scientific Title of Study
|
Comparative evaluation of proximal contact tightness of class 2 cavities restored using different matrix systems: A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chinta Priyanka Reddy |
| Designation |
Post graduate student |
| Affiliation |
Drs sudha and nageswararao siddhartha institute of dental sciences |
| Address |
Department of conservative dentistry and endodontics
Drs sudha and nageswararao siddhartha institute of dental sciences
Chinnoutpally
Gannavaram mandal
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9493672455 |
| Fax |
|
| Email |
saipriyanka.chinta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tanikonda Rambabu |
| Designation |
HOD and Professor |
| Affiliation |
Drs sudha and nageswararao siddhartha institute of dental sciences |
| Address |
Department of conservative dentistry and endodontics
Drs sudha and nageswararao siddhartha institute of dental sciences
Chinnoutpally
Gannavaram mandal
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9440364064 |
| Fax |
|
| Email |
rambabumds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chinta Priyanka Reddy |
| Designation |
Post graduate student |
| Affiliation |
Drs sudha and nageswararao siddhartha institute of dental sciences |
| Address |
Department of conservative dentistry and endodontics
Drs sudha and nageswararao siddhartha institute of dental sciences
Chinnoutpally
Gannavaram mandal
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9493672455 |
| Fax |
|
| Email |
saipriyanka.chinta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Drs Sudha and Nageswara Rao Siddhartha Institute of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
Chinta Priyanka Reddy |
| Address |
Ch.Priyanka Reddy
Post graduate student
Department of conservative dentistry and endodontics
Drs sudha and nageswararao siddhartha institute of dental sciences
Chinnoutpally
Gannavaram mandal
|
| 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 |
| Chinta Priyanka Reddy |
Drs sudha and nageswar rao siddhartha institute of dental sciences |
Department of Conservative Dentistry and Endodontics
First Floor
Room no 7
Krishna
ANDHRA PRADESH |
09493672455
saipriyanka.chinta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Drs Sudha and Nageswara rao siddhartha institute of dental sciences |
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 |
bioclear matrix |
Sectional matrix band is placed after excavation of caries and is restored.The time duration for this entire process will be approximately 1-1.5 hrs. |
| Comparator Agent |
palodent v3 |
sectional matrix band is placed after excavation of the caries and the tooth is restored.the time duration for this entire process will be approximately 1-1.5 hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Class II dental caries
2. Adjacent and opposing teeth should be present
|
|
| ExclusionCriteria |
| Details |
1.Deep dentinal caries
2.Subgingival caries
3.Tooth with poor periodontal health
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| contact tightness evaluation |
immediately and one week after restoration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not appicable |
not applicable |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2020 |
| Date of Study Completion (India) |
28/05/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Sixty posterior tooth with carious lesion involving the proximal walls will be taken in to the study. In this study the samples will be randomized and will be divided into groups based on the matrix system with which the tooth structure will be reconstructed.In the group 1 the samples after carious excavation will be restored by placing bioclear matrix band and in group 2 the samples will be restored by placing palodent v3 matrix band.After the restoration the contact tightness will be evaluated by radiographic and floss method immediately and 1week after restoration by blinded investigator. |