CTRI Number |
CTRI/2022/06/043411 [Registered on: 22/06/2022] Trial Registered Prospectively |
Last Modified On: |
22/05/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparing two techniques of minimally invasive method of stainless steel crown in children. |
Scientific Title of Study
|
Clinical evaluation of preformed stainless-steel crowns placed with modified versus standard hall technique in management of occluso-proximal dentinal caries in primary molars. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Rini C |
Designation |
PG student |
Affiliation |
SGT university |
Address |
Room no.6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurgaon.
Gurgaon HARYANA 122505 India |
Phone |
9953249879 |
Fax |
|
Email |
dr.rinichacko@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shalini Garg |
Designation |
Professor |
Affiliation |
SGT University |
Address |
Room no.6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurgaon
Gurgaon HARYANA 122505 India |
Phone |
9215668621 |
Fax |
|
Email |
shalini_fdsc@sgtuniversity.org |
|
Details of Contact Person Public Query
|
Name |
Rini C |
Designation |
PG Student |
Affiliation |
SGT university |
Address |
Room no.6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurgaon
Gurgaon HARYANA 122505 India |
Phone |
9953249879 |
Fax |
|
Email |
dr.rinichacko@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
SGT University |
Address |
Faculty of Dental Science, SGT University, Gurugram-122505 |
Type of Sponsor |
Research institution and hospital |
|
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 |
Rini C |
SGT University |
Room no.6, Department of Pediatric and Preventive Dentistry, Faculty of Dental sciences, Chandu Budhera, Gurugram Gurgaon HARYANA |
9953249879
dr.rinichacko@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SRI GURUGOBIND SINGH TRICENTENARY UNIVERSITY, GURGAON |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Dental Caries |
Patients |
, (1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Clinical evaluation of preformed stainless-steel crowns placed with modified versus standard hall technique in management of occluso-proximal dentinal caries in primary molars. |
Comparative assessment of occlusion by modified (with proximal slicing) versus standard hall technique (non-invasive) and to assess child’s intraoperative behaviour, chair time and clinical success after placement of preformed stainless-steel crown with occluso-proximally carious primary molars over a period of 03 months. |
Comparator Agent |
nil |
nil |
Intervention |
Randomized Clinical trial |
Comparative assessment of occlusion by modified (with proximal slicing) versus standard hall technique (non-invasive) and to assess child’s intraoperative behaviour, chair time and clinical success after placement of preformed stainless-steel crown with occluso-proximally carious primary molars over a period of 03 months. |
|
Inclusion Criteria
|
Age From |
4.00 Year(s) |
Age To |
9.00 Year(s) |
Gender |
Both |
Details |
1. A case of Occluso-proximal dentinal caries in primary molar
2. The lesion ICDAS should not be less than 4 and more than 5.
3. Radiographic examination should not show caries involvement more than half of dentinal shadow.
4. The occlusal surface should not be involved more than half of total dimension (occlusal table).
|
|
ExclusionCriteria |
Details |
1. Sign and Symptoms of irreversible pulpitis.
2. Peri apical/ inter radicular Radiographic changes due to caries.
3. Patient with severe occlusal discrepancies.
4. Pre-treated, restorative treatment done on the tooth.
|
|
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 |
Clinical evaluation of preformed stainless-steel crowns placed with modified versus standard hall technique in management of occluso-proximal dentinal caries in primary molars. |
Clinical evaluation immediately, at1 week,1month,2month, 3month, and 6month for all the cases. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To evaluate clinical success and effectiveness on occurrence of new caries. |
Clinical evaluation and patient acceptance at 6months and 12months |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
22/06/2022 |
Date of Study Completion (India) |
21/06/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
21/06/2023 |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
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
|
The hall technique is minimally invasive type of caries management technique for treating occluso-proximal carious primary molars. The hall technique has biological principle as it can arrest caries and protect the tooth until it sheds. The essential layer in the biofilm responsible for caries progression (superficial plaque layer), is left and sealed along with the caries. As a response the composition of the plaque biofilm will be altered to a less cariogenic flora. Using hall technique, the crown is cemented without local anaesthesia, caries removal or tooth preparation. As occlusal reduction is not done in standard hall technique, there will be discrepancy in the occlusion and occlusal vertical dimension. In modified hall technique the occlusion might settle faster as compared to standard halls technique due to minimal occlusal reduction done prior to the placement of Preformed Stainless Steel Crown (PMC). In intraoperative stage, patient acceptance regarding pain and anxiety can be recorded using self-reported Wong Baker Faces Pain Rating Scale. Children have to select from six faces which represent closely to how they felt at the time of assessment and Frankl scores can also be evaluated. This study aims to assess the occlusion after placement of preformed stainless-steel crown in occluso–proximally carious primary molars by modified versus standard hall technique over period of 12months and also to assess the child’s intraoperative behaviour acceptance after placement of preformed stainless-steel crown.
|