| CTRI Number |
CTRI/2022/07/043762 [Registered on: 06/07/2022] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating and comparing two agents namely- Silver Diamine Fluoride (SDF) and Universal Bonding Agent (UBA) in reducing dental caries and dental hypersensitivity in decayed hypoplastic (weak) permanent molar teeth. |
|
Scientific Title of Study
|
Comparative evaluation of Silver Diamine Fluoride (SDF) and Universal Bonding Agent (UBA) in reducing dental caries and dental hypersensitivity in cariously affected (ICDAS 1-4) Molar Incisor Hypoplastic (MIH) permanent molar teeth. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CHERANJEEVI JAYAM |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
All India Institute Of Medical Sciences Mangalagiri |
| Address |
DEPARTMENT OF DENTISTRY, ROOM NO 441, 4TH FLOOR, OPD BUILDING, AIIMS, MANGALAGIRI, GUNTUR DISTRICT, ANDHRA PRADESH.
DEPARTMENT OF DENTISTRY, ROOM NO 441, 4TH FLOOR, OPD BUILDING, AIIMS, MANGALAGIRI, GUNTUR DISTRICT, ANDHRA PRADESH.
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8894337313 |
| Fax |
|
| Email |
cheranjeevij@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
CHERANJEEVI JAYAM |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
All India Institute Of Medical Sciences Mangalagiri |
| Address |
DEPARTMENT OF DENTISTRY, ROOM NO 441, 4TH FLOOR, OPD BUILDING, AIIMS, MANGALAGIRI, GUNTUR DISTRICT, ANDHRA PRADESH.
DEPARTMENT OF DENTISTRY, ROOM NO 441, 4TH FLOOR, OPD BUILDING, AIIMS, MANGALAGIRI, GUNTUR DISTRICT, ANDHRA PRADESH.
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8894337313 |
| Fax |
|
| Email |
cheranjeevij@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
CHERANJEEVI JAYAM |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
All India Institute Of Medical Sciences Mangalagiri |
| Address |
DEPARTMENT OF DENTISTRY, ROOM NO 441, 4TH FLOOR, OPD BUILDING, AIIMS, MANGALAGIRI, GUNTUR DISTRICT, ANDHRA PRADESH.
DEPARTMENT OF DENTISTRY, ROOM NO 441, 4TH FLOOR, OPD BUILDING, AIIMS, MANGALAGIRI, GUNTUR DISTRICT, ANDHRA PRADESH.
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8894337313 |
| Fax |
|
| Email |
cheranjeevij@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTIONAL SOURCE- ALL INDIA INSTITUTE OF MEDICAL SCIENCES MANGALAGIRI |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES MANGALAGIRI |
| Address |
DEPARTMENT OF DENTISTRY, 441, 4TH FLOOR, OPD BUILDING, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, MANGALAGIRI, GUNTUR, ANDHRA PRADESH |
| Type of Sponsor |
Government medical college |
|
|
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 |
| CHERANJEEVI JAYAM |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES MANGALAGIRI |
440, DEPARTMENT OF DENTISTRY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES MANGALAGIRI
Guntur
ANDHRA PRADESH |
8894337313
cheranjeevij@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS MANGALAGIRI INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K004||Disturbances in tooth formation, (2) ICD-10 Condition: K026||Dental caries on smooth surface, (3) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Silver Diamine Fluoride |
Application of Silver Diamine Fluoride in a hypoplastic (MIH) decayed permanent teeth to arrest progression. |
| Intervention |
Universal bonding agent |
Application of any commercially available Universal Bonding Agent on hypoplastic (MIH) decayed permanent teeth to arrest progression. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
children aged 6- 14 years of age
MIH teeth with ICDAS- 2 score containing first digit 0, second digit scores of 1-4 |
|
| ExclusionCriteria |
| Details |
1. Teeth that have undergone any kind of restoration coded as per ICDAS restoration/ sealant code 1 to 9 (first digit)
2. history of spontaneous or elicited pain from caries.
3. pathological tooth mobility
4. signs of pulpal infection
5. children with severe medical conditions.
6. hereditary developmental defects like amelogenesis imperfecta or dentinogenesis imprefecta.
7. teeth with fluorotic hypoplasia
8. known allergies or sensitivities to dental materials used in the study (like SDF/ UBA)
9. definitely uncooperative children (Frankl definitely negative) |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessing for caries arrest:
Positive outcomes - Dark, hard, and black lesions with no pain or infection
Negative outcomes -Progression of the lesion, a yellow, brown, soft lesion with or without pain or infection.
Assessing dental hypersensitivity: (Schiff Cold Air Sensitivity Scale (SCASS) and / or VAS scores will used to assess the presence of hypersensitivity).
Positive outcomes – Improvement in SCASS and / or VAS scores
Negative outcomes- No improvement or worsening of SCASS and / or VAS scores
|
Children shall be followed-up and re-evaluated using ICDAS-2 scale after 3 weeks, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| aesthetic outcome: Likert-scale questionnaire shall be used in children to know outcome. |
Children shall be followed-up and re-evaluated using ICDAS-2 scale after 3 weeks, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="178"
Sample Size from India="178"
Final Enrollment numbers achieved (Total)= "220"
Final Enrollment numbers achieved (India)="220" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2022 |
| Date of Study Completion (India) |
01/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Submitted for peer review |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study is a Randomized, Parallel Group
Trial Evaluating and comparing two agents namely- Silver Diamine Fluoride (SDF)
and Universal Bonding Agent (UBA) in reducing dental caries and dental
hypersensitivity in decayed hypoplastic (weak) permanent molar teeth. Both
agents shall be applied in children aged 6- 14 years in MIH teeth with ICDAS scores
1-4. Participant and Outcome Assessor Blinded and same children will be
assessed for continuation/ arrest of dental caries and dentinal
hypersensitivity at regular intervals of 3 weeks, 3 months, 6 months and 9
months. The primary outcome measures of the study are caries arrest, assessed
by changes in color and texture, and a decrease in dental hypersensitivity
measured by predefined SCASS and VAS scores. The results indicated that out of 243
teeth, 212 teeth (111 belonging to the SDF group and 101 belonging to the UBA
group) were available for follow-up at the end of the 9-month follow-up period.
The ICDAS categorization and Schiff Cold Air Sensitivity Scale (SCASS) of the
available 212 teeth were recorded. The study also included intra- and
inter-group comparison of both agents pre-operatively and post-operatively at 9
months, which was summarized. The statistical analysis showed no statistically
significant reduction in the ICDAS scores for both the SDF and UBA groups.
However, there was a statistically significant reduction in the sensitivity
score (Schiff score) between the pre- and post-values for both the SDF and UBA
groups.
The rate of reduction between the study
groups showed no statistical difference, indicating that both had a similar
effect. |