| CTRI Number |
CTRI/2024/05/066677 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Tooth Treatments for Kids: Minimal vs Standard Methods in Baby Teeth |
|
Scientific Title of Study
|
A Comparative Evaluation of Conservative and Conventional Access Cavity Preparation in Primary Molars – A Randomized Clinical 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 |
SHALINI B |
| Designation |
PG STUDENT |
| Affiliation |
|
| Address |
Room No.4, Department of Pediatric and Preventive Dentistry, Sri Ramachandra Dental College and Hospital, Mount Poonamallee Road, Sri Ramachandra nagar, Iyyappanthangal, Chennai - 600116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
|
| Fax |
|
| Email |
d1123003@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Selvakumar |
| Designation |
Associate Professor |
| Affiliation |
SRI RAMACHANDRA DENTAL COLLEGE AND HOSPITAL |
| Address |
Room No.4, Department of Pediatric and Preventive Dentistry, Sri Ramachandra Dental College and Hospital, Mount Poonamallee Road, Sri Ramachandra nagar, Iyyappanthangal, Chennai - 600116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9840275503 |
| Fax |
|
| Email |
selvakumaarh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHALINI B |
| Designation |
PG STUDENT |
| Affiliation |
SRI RAMACHANDRA DENTAL COLLEGE AND HOSPITAL |
| Address |
Room No.4, Department of Pediatric and Preventive Dentistry, Sri Ramachandra Dental College and Hospital, Mount Poonamallee Road, Sri Ramachandra nagar, Iyyappanthangal, Chennai - 600116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9003149005 |
| Fax |
|
| Email |
d1123003@sriher.edu.in |
|
|
Source of Monetary or Material Support
|
| The trial will receive essential equipment and supplies, including dental instruments, imaging devices (e.g., intraoral radiography), and materials for cavity preparation and restoration, from the Department of Pediatric and Preventive Dentistry at Sri Ramachandra Dental College and Hospital. |
|
|
Primary Sponsor
|
| Name |
SHALINI B |
| Address |
Room No.4, Department of Pediatric and Preventive Dentistry, Sri Ramachandra Dental College and Hospital, Mount Poonamallee Road, Sri Ramachandra nagar, Iyyappanthangal, Chennai - 600116 |
| 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 |
| SHALINI B |
Sri Ramachandra Dental College and Hospital |
Room No.4, Department of Pediatric and Preventive Dentistry, No. 1, Mount Poonamallee Road, Sri Ramachandra nagar, Iyyappanthangal, Chennai - 600116
Thiruvallur
TAMIL NADU |
9003149005
d1123003@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR NON-MEDICAL PG AND UG STUDENTS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conservative access cavity preparation in primary molars |
Using radiographs, the outline of the conservative cavity will be determined by a line drawn from the outer canal surface at the primary canal curve through the outer canal surface at the level of furcation. This will be replicated while performing on patients. The access cavities will be prepared using a sterile medium-size round bur and non-end cutting bur (Mani Inc., Utsunomiya, Japan) in a high-speed handpiece. The canals will be identified using DG16 endodontic explorer. Root canal patency will be obtained using a K-File of size 10. The canals will be prepared using a nickel-titanium Pedoflex rotary file system of file sizes 20 (yellow) and 25 (red) of length 16mm and 4% taper using an endodontic motor. The canals will be irrigated with 0.9% normal saline and 2.5% sodium hypochlorite (Prime Dental Products Pvt. Ltd., Mumbai, India) using SuperEndo Sonic Flush Irrigator between the use of each instrument to eliminate debris. The final irrigation will be carried out with 17% EDTA. Canals will be dried using sterile paper points and will be filled with calcium hydroxide and iodoform (Metapex) followed by restoration with Type IX glass ionomer cement and a preformed Stainless steel crown.
|
| Comparator Agent |
Conventional access cavity preparation in primary molars |
Using radiographs, the outline of the conventional cavity will be a line drawn parallel to the external surface of the pulp chamber to the curvature of the primary canal with respect to maximum curvature. This will be replicated while performing on patients. The access cavities will be prepared using a sterile medium-size round bur and non-end cutting
bur (Mani Inc., Utsunomiya, Japan) in a high-speed handpiece. The canals will be identified
using DG16 endodontic explorer. Root canal patency will be obtained using a K-File of size
10. The canals will be prepared using a nickel-titanium Pedoflex rotary file system of file sizes 20 (yellow) and 25 (red) of length 16mm and 4% taper using an endodontic motor.
The canals will be irrigated with 0.9% normal saline and 2.5% sodium hypochlorite (Prime
Dental Products Pvt. Ltd., Mumbai, India) using SuperEndo Sonic Flush Irrigator between the
use of each instrument to eliminate debris. The final irrigation will be carried out with 17% EDTA. Canals will be dried using sterile paper points and will be filled with calcium hydroxide and iodoform (Metapex) followed by restoration with resin composite.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
-Children aged 6-10 who require endodontic treatment.
-Primary molars with occlusal caries and intact marginal ridges (only for conservative
access cavity design)
-No tooth mobility
-Radiographically, caries involving pulp
|
|
| ExclusionCriteria |
| Details |
-Patients unwilling to participate.
-Grossly mutilated crown.
-Root resorption of more than one-third of the root
-Children with underlying systemic conditions, special healthcare needs and known
haematological/craniofacial disorders
-Children allergic to local anaesthetic agents.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Determining the success/failure of endodontic
treatment after a 12-month period. The success of
the restoration will be assessed for marginal integrity, the presence of secondary caries, and any instances of fractured restoration.
Simultaneously, stainless steel crowns (SSCs) will be evaluated to identify any instances of perforation and crown loss.
|
Clinical and radiographical
evaluation will be conducted at intervals of 1, 3, 6, and 12 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determining the success of restoration and stainless steel crowns |
Clinical and radiographical
evaluation will be conducted at intervals of 1, 3, 6, and 12 months.
|
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 2 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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-identification.
- 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 (Others) -
- By what mechanism will data be made available?
Response (Others) - The data will be used to present at the conferences or conventions that are a part of the PG curriculum
- For how long will this data be available start date provided 04-04-2024 and end date provided 04-10-2026?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized, parallel-group clinical trial comparing the clinical and radiographic outcomes of endodontic treatment with conventional and conservative access cavities in primary molars among children undergoing pulp therapy. Pediatric patients reporting to the Department of Pediatric and Preventive Dentistry, SRIHER, who meet the inclusion criteria will be recruited. Children who meet the inclusion criteria will be randomly allocated to either of the 2 groups based on the randomization list. Study group (Group A): Conservative endodontic access cavity restored with resin composite. Control group (Group B): Conventional endodontic access cavity restored with Type IX glass ionomer cement followed by Stainless steel crown. The primary outcome of this study will be determining the success/failure of endodontic treatment after 12 months. To be categorized as having overall success, the evaluated tooth must demonstrate both clinical and radiographic success. Clinical and radiographical evaluation will be conducted at intervals of 1, 3, 6, and 12 months. Additionally, the success of the restoration and stainless steel crowns will be evaluated.
|