| CTRI Number |
CTRI/2024/11/076302 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study To Assess The Clinical Performance Of Full Crown And Onlay Restorations Of Root Canal Treated Tooth-An 18 Months Follow-Up Study |
|
Scientific Title of Study
|
Comparative Evaluation Of The Clinical Performance Of Full Crown With That Of Onlay As Post Endodontic Restoration-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 |
Fathima Fasniyya VK |
| Designation |
Junior Resident |
| Affiliation |
Government Dental College Kozhikode |
| Address |
Department Of Conservative Dentistry And Endodontics Room No 60
Government Dental College Kozhikode
Kozhikode
Kerala
673008
Kozhikode
KERALA
673008
India |
| Phone |
7907733105 |
| Fax |
|
| Email |
fasniyashimil1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayasree S |
| Designation |
Professor And Head Of The Department |
| Affiliation |
Government Dental College Kozhikode |
| Address |
Department Of Conservative Dentistry And Endodontics Room No 60
Government Dental College Kozhikode
Kozhikode
Kerala
673008
Kozhikode
KERALA
673008
India |
| Phone |
9447276940 |
| Fax |
|
| Email |
jsree21@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayasree S |
| Designation |
Professor And Head Of The Department |
| Affiliation |
Government Dental College Kozhikode |
| Address |
Department Of Conservative Dentistry And Endodontics Room No 60
Government Dental College Kozhikode
Kozhikode
Kerala
673008
Kozhikode
KERALA
673008
India |
| Phone |
9447276940 |
| Fax |
|
| Email |
jsree21@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Dental College Kozhikode
Medical College Campus
Kozhikode
Kerala
India
673008 |
|
|
Primary Sponsor
|
| Name |
Fathima FasniyyaVK |
| Address |
Department Of Conservative Dentistry And Endodontics
Room No 60
Government Dental College Kozhikode
Kerala
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 |
| Fathima Fasniyya VK |
Government Dental College Kozhikode |
Department Of Conservative Dentistry And Endodontics
Government Dental College Kozhikode
Kerala
673008
Kozhikode
KERALA |
7907733105
fasniyashimil1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee 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 |
| Comparator Agent |
Full Crown |
Evaluation Of Clinical Performance Of Full Crown Restorations Of 60 Root Canal Treated Teeth Over A Period Of 18 Months |
| Intervention |
Onlay |
Evaluation Of Clinical Performance Of Onlay Restorations Of 60 Root Canal Treated Teeth Over A Period Of 18 Months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient 20-40 Age Group Including Male And Females
Patient With At Least One Proximal Surface Involvement With Intact Buccal And Lingual Surface
Systemically Healthy Individual Who Had At Least One Endodontically Treated Mandibular First Molar Teeth With No Clinical Signs And Symptoms Or
Periapical Pathology Good Bone Support
Teeth With Adequate Contact With Adjacent And Opposite Teeth
Patient With Good Oral Hygiene And Plaque Control
Those Who Willingness To Sign The Informed Consent
|
|
| ExclusionCriteria |
| Details |
Poor Oral Hygiene Or Para Functional Habits
Poor Periodontal Status
Those With No Opposing Teeth Or Adjacent Teeth
Patient With Systemic Disease
Any Gross Oral Pathologies
Pregnancy And Lactation
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative Evaluation Of The Clinical Performance Of Full Crown And Onlay As A Post Endodontic Restoration |
18 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluating The Clinical Performance Of Full Crown And Onlay Restorations Using Modified USPHS Criteria |
0 Months 6 Months 12 Months 18 Months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
08/11/2024 |
| 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 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 - 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 09-11-2026 and end date provided 09-11-2029?
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
|
Restoration Of Endodontically Treated Teeth Is Essential. Full Coverage Crowns Are The Golden Standard Post Endodontic Restoration Of Choice. Minimally Invasive Partial Coverage Restoration Like Onlays Are Restoration Which Involve The Proximal Surface Of Posterior Tooth And Caps All Of The Cusps .Onlay Conserve The Periradicular Dentine And Minimal Tooth Preparatioin. Purpose Of This Study To Compare The Clinical Performance Of Full Crown And Onlay As A Post Endodontic Restoration Over A Period Of 18 Months |