| CTRI Number |
CTRI/2024/11/076900 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find out the pain and discomfort after giving crown by two different technique Halls technique vs Conventional technique |
|
Scientific Title of Study
|
Assessment of post-operative discomfort and effect on occlusion after placing Stainless Steel Crown by Halls technique vs Conventional technique: A Randomised Control 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 |
Dr K Madhumita |
| Designation |
Junior Resident Academic |
| Affiliation |
All India Institute of Medical Sciences, Deoghar. |
| Address |
Unit of Pediatric and Preventive Dentistry, Department of Dentistry, All India Institute of Medical Sciences, Deoghar, Devipur, Jharkhand.
Deoghar
JHARKHAND
814152
India |
| Phone |
9047494928 |
| Fax |
|
| Email |
madhumitakumararaja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok kumar |
| Designation |
Head and Professor |
| Affiliation |
All India Institute of Medical Sciences, Deoghar. |
| Address |
Department of Dentistry, All India Institute of Medical Sciences, Deoghar, Devipur, Jharkhand.
Deoghar
JHARKHAND
814152
India |
| Phone |
9971903750 |
| Fax |
|
| Email |
ashok.dentistry@aiimsdeoghar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok kumar |
| Designation |
Head and Professor |
| Affiliation |
All India Institute of Medical Sciences, Deoghar. |
| Address |
Department of Dentistry, All India Institute of Medical Sciences, Deoghar, Devipur, Jharkhand.
Deoghar
JHARKHAND
814152
India |
| Phone |
9971903750 |
| Fax |
|
| Email |
ashok.dentistry@aiimsdeoghar.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Deoghar, Devipur, Jharkhand-814152. |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Deoghar. |
| Address |
Unit of Pediatric and Preventive Dentistry, All India Institute of Medical Sciences, Deoghar,Devipur, Jharkhand-814152. |
| 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 |
| DrK Madhumita |
All India Institute of Medical sciences, Deoghar. |
Unit of Pediatric and Preventive Dentistry, Department of Dentistry, All India Institute of Medical Sciences, Deoghar, Devipur, Jharkhand - 814152.
Deoghar
JHARKHAND |
9047494928
madhumitakumararaja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC OF ALL INDIA INSTITUTE OF MEDICAL SCIENCES DEOGHAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
DENTAL CARIES WITH ICDAS SCORE 4 AND 5 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL SSC TECHNIQUE |
3M STAINLESS STEEL CROWN PLACEMENT AFTER TOOTH PREPARATION IN CARIOUS TEETH HAVING ICDAS SCORE 4 AND 5.
Assessment of pain and discomfort for a period of 1 year. |
| Intervention |
HALLS TECHNIQUE |
3M Stainless steel crown placement without tooth preparation in the carious teeth having ICDAS score 4 and 5. Assessment of pain and occlusal discomfort for period of 1 year. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
I. Cooperative Children of age between 4-8 years with Frankle Rating 3 and 4.
II. First/Second deciduous molar teeth with occlusal and proximal caries diagnosed using the International Caries Detection, and Assessment System (ICDAS) with criteria codes 4 and 5
III. Tooth with no symptom of pain.
IV. Fully erupted tooth
|
|
| ExclusionCriteria |
| Details |
I. Any signs or symptoms of pulpal or periapical pathology.
II. Medically compromised Children.
III. Uncooperative children.
IV. Inadequate crown structure unable to retain the crown.
V. Bruxism
VI. Tooth with abnormal mobility
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the presence of patient discomfort, and pain in the tooth and Temporomandibular Joint (TMJ) after placing Stainless Steel Crown (SSC) using Hall technique versus Conventional technique.
2. To evaluate effects on occlusion such as overbite, midline deviations, and intraoral Occluso-vertical dimension.
|
Clinical parameters will be evaluated at pre-op, immediate post-op, day after, 1st week, 2nd week, 3rd week, and 4th week post-operatively or at weekly intervals till occlusal settlement. Then at 3 months, 6 months, and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the marginal adaptability of the SSC crown using an Intraoral Periapical (IOPA) Radiograph.
2. To evaluate the treatment time for placing SSC in both Halls & Conventional techniques.
3. To evaluate the gingival health after SSC crown placement.
|
Marginal adaptability will be assessed using an IOPA X-ray immediately post-op. Loe & Silness Gingival index will evaluate gingival health preoperatively, baseline,after 1day, 1 week, 2nd week, 3rd week, 4th week, 3,6,and 12 month |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
25/11/2024 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Participants of dental caries ICDAS Scores 4 and 5 between the age group of 4-8 years will be divided into control and intervention groups. The control group will receive a 3M stainless steel crown after crown preparation. The intervention group will receive a 3M stainless steel crown without crown preparation. Clinical (pain in teeth and TMJ, overbite, intraoral vertical dimension, and midline deviation) and radiological (marginal adaptability) will be assessed in these patients with stainless steel crowns(SSCs) while using two different techniques. Clinical parameters will be evaluated at pre-op, immediate post-op, day after, 1st week, 2nd week, 3rd week, and 4th week post-operatively or at weekly intervals till occlusal settlement. Then at 3 months, 6 months, and 12 months. Marginal adaptability will be assessed using an IOPA X-ray immediately post-op. Loe and Silness Gingival index will be evaluated gingival health postoperatively and at every visit. |