| CTRI Number |
CTRI/2024/06/068318 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the clinical performance of Clark’s class II and conventional cavity design for resin -based composites. |
|
Scientific Title of Study
|
Clinical performance of Clarks and Conventional cavity design preparation for class II resin based composites: A Randomised Controlled 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 |
Deepti Goklani |
| Designation |
MDS Student |
| Affiliation |
JSS Dental College and Hospital, Mysore |
| Address |
Department of Conservative Dentistry and Endodontics, Room no. 7, JSS Dental College and Hospital, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
6386707081 |
| Fax |
|
| Email |
dgoks777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinutha Manjunath |
| Designation |
Reader |
| Affiliation |
JSS Dental College and Hospital, Mysore |
| Address |
Department of Conservative Dentistry and Endodontics, Room no. 7, JSS Dental College and Hospital, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
9886555462 |
| Fax |
|
| Email |
dr.vinutham@jssuni.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Deepti Goklani |
| Designation |
MDS Student |
| Affiliation |
JSS Dental College and Hospital, Mysore |
| Address |
Department of Conservative Dentistry and Endodontics, Room no. 7, JSS Dental College and Hospital, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
6386707081 |
| Fax |
|
| Email |
dgoks777@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Dental College and Hospital, Mysuru, Karnataka, India
Pincode - 570015 |
|
|
Primary Sponsor
|
| Name |
Deepti Goklani |
| Address |
Department of Conservative Dentistry and Endodontics, Room no. 7, JSS Dental College and Hospital, Mysuru |
| 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 Deepti Goklani |
JSS Dental College and Hospital, Mysuru |
JSS Dental College and Hospital, Room no. 7, Department of Conservative Dentistry and Endodontics, Mysuru
Mysore
KARNATAKA |
6386707081
dgoks777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
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 |
Clark’s Class II (saucer shaped) cavity preparation |
In this group, the prepared Clarks cavity will be restored with a layer of heated flowable resin composite followed by a layer of heated bulkfill resin composite (injection overmoulding technique) |
| Comparator Agent |
Conventional box/ slot class II cavity preparation |
In this group, the prepared cavity will be restored with the conventional bulkfill resin based composites following the traditional protocol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Class II Carious Pre-molars & Molars (i.e., with proximal caries alone or proximal and occlusal caries viz. MO or DO)
-Lesion extending into middle one-third of dentine (i.e., D2 according to the radiographic assessment of caries, determined by bitewing radiographs)
-Failed or fractured class II amalgam restoration
-Tooth with adjacent teeth
|
|
| ExclusionCriteria |
| Details |
-Medically compromised patients
-Prosthesis or previous extensive existing restoration
-Symptomatic irreversible pulpitis
-Tooth with any periapical pathology
-Worn out dentition
-Patients with parafunctional habits
|
|
|
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 |
| The restorations will be evaluated by a blinded assessor according to modified USPHS or Ryge criteria |
After 6 months, 12 months and 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
20/06/2024 |
| 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="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
|
Population (P) -Participants with class II carious pre-molars & molars (i.e., with proximal caries alone or proximal and occlusal caries viz. MO or DO with lesion extending into middle one-third of dentine (i.e., D2 according to the radiographic assessment of caries, determined by bitewing radiographs)
Intervention (I) - Preparation of Clark’s class II cavity design and restoration with dental resin composite.
Comparator (C) - Preparation of conventional class II cavity design and restoration with dental resin composite.
Outcome (O) - The restorations will be evaluated by a blinded assessor according to modified USPHS or Ryge criteria after 6 months, 12 months and 18 months. |