| CTRI Number |
CTRI/2024/11/076512 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study Of Direct And Indirect Filling Methods For The Decay On Smooth Surfaces Of The Teeth-An 18 Months Follow-Up Study |
|
Scientific Title of Study
|
Comparative Clinical Evaluation Of Class II Direct And Indirect Composite Restorations-An 18 Months Longitudinal 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 |
Dr Aneetta Joseph |
| Designation |
Junior resident |
| Affiliation |
Government dental college,Kozhikode |
| Address |
Junior resident,Room no:60,Department of conservative dentistry and endodontics,Government dental college,Kozhikode,Kerala
Kozhikode
KERALA
673008
India |
| Phone |
9995631053 |
| Fax |
|
| Email |
annumaria001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JAYASREE S |
| Designation |
Head of the department |
| Affiliation |
Government dental college,Kozhikode |
| Address |
Head of the department,Room no:60,Department of conservative dentistry and endodontics,Government dental college,Kozhikode,Kerala
Kozhikode
KERALA
673008
India |
| Phone |
9447276940 |
| Fax |
|
| Email |
jsree21@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr JAYASREE S |
| Designation |
Head of the department |
| Affiliation |
Government dental college,Kozhikode |
| Address |
Head of the department,Room no:60,Department of conservative dentistry and endodontics,Government dental college,Kozhikode,Kerala
Kozhikode
KERALA
673008
India |
| Phone |
9447276940 |
| Fax |
|
| Email |
jsree21@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Govt.Dental College,Kozhikode,
Calicut Medical College Po,
Kerala, India - 673008.
|
|
|
Primary Sponsor
|
| Name |
Dr Aneetta Joseph |
| Address |
Junior resident,Room no:60,Department of conservative dentistry and endodontics,Government dental college,Kozhikode,Calicut medical college po,Kerala,India,673008 |
| 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 Aneetta Joseph |
Government dental college Kozhikode |
Room No:60,Department Of Conservative Dentistry And Endodontics,Government Dental College,Kozhikode,Calicut Medical College Po,Kozhikode, Kerala,India,673008
Kozhikode
KERALA |
9995631053
annumaria001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE GOVERNMENT DENTAL COLLEGE KOZHIKODE |
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 |
Direct Composite Restorations |
Evaluation Of Clinical Performance Of Class II Direct Restorations Over A Period Of 18 Months |
| Comparator Agent |
Inirect Composite Restorations |
Evaluation Of Clinical Performance Of Class II Indirect Restorations Over A Period Of 18 Months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Moderate to deep class II cavities with ICDAS clinical scoring 4 and 5 and with Radiographic scoring RB 4
Cavities with isthmus size at least half of the inter cuspal distance
No clinical signs and symptoms of pulpal or periapical pathology
The carious tooth should have adjacent and antagonistic teeth
In occlusion to antagonistic teeth
Good oral hygiene
|
|
| ExclusionCriteria |
| Details |
Patients with Severe systemic diseases and allergies,
Severe periodontal problems and subgingival caries,
Parafunctional habits like bruxism or clenching,
Restricted mouth opening |
|
|
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 |
Comparative clinical evaluation of class II direct and indirect composite
restorations over a period of 18 months. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluating the clinical performance of direct and indirect restoration methods using revised FDI criteria,at the end of 1 month,6 months and 18 months |
1 month to 18 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/11/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - Requested data will be mailed
- For how long will this data be available start date provided 01-11-2026 and end date provided 01-11-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Proximal surfaces are the second, following the occlusal surfaces as being the most exposed places to the carious process.A successful class II restoration always remains a nightmare to the dentist as it requires proper interproximal contacts and contours, and marginal adaptation which is necessary for a healthy periodontium.Adhesive restorative materials like COMPOSITE RESINS have strong bond to enamel and dentin facilitating proper contacts and contours.The polymerization shrinkage, improper marginal sealing, post operative sensitivity, recurrent caries are some of the challenges that have to be addressed in direct technique.The remains of uncured resin in deeper portions of cavity elute further and cause severe pulpal irritation in direct composite restorations.Indirect resin composite restorations mitigate some of the drawbacks of the direct technique and theoretically ensure a relatively longer life span of the restorations.There are only fewer data available on clinical comparison between direct and indirect class II composite restorations.Hence this study is intended to compare the clinical performance of direct and indirect class II composite restorations using the FDI criteria as the main evaluation tool |