| CTRI Number |
CTRI/2024/07/071687 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To evaluate effectiveness of 38 percent silver diamine fluoride in arresting dental caries of permanent teeth using atraumatic restorative treatment (ART) and conventional GIC restoration An interventional study |
|
Scientific Title of Study
|
To evaluate application of 38 percent silver diamine fluoride in arresting dental caries of permanent teeth using atraumatic restorative treatment ART and conventional GIC restoration An interventional 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 |
Nandani Tiwari |
| Designation |
PG 2nd year |
| Affiliation |
Government College of Dentistry, Indore,MP |
| Address |
Room number 13, Department of Public Health Dentistry, Government College of dentistry ,Indore
Near MY hospital
Indore
MADHYA PRADESH
452001
India |
| Phone |
7020926675 |
| Fax |
|
| Email |
nandyt18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vrinda Saxena |
| Designation |
Professor, Head of department, Govt College of dentistry, Indore |
| Affiliation |
Government college of dentistry ,Indore |
| Address |
Room number13 , Department of Public Health Dentistry , Government College of dentistry ,Indore
Near MY hospital
Indore
MADHYA PRADESH
452001
India |
| Phone |
9981175126 |
| Fax |
|
| Email |
dr.vrinda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vrinda Saxena |
| Designation |
Professor, Head of department, Govt College of dentistry, Indore |
| Affiliation |
Government college of dentistry ,Indore |
| Address |
Room number 13, Dept of Public Health Dentistry , Government College of Dentistry ,Indore
Near MY hospital
MADHYA PRADESH
452001
India |
| Phone |
9981175126 |
| Fax |
|
| Email |
dr.vrinda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Nandani Tiwari
Room number 13, Dept of Public Health Dentistry, Government College of Dentistry, Indore, MP, India , Pin code : 452001 |
|
|
Primary Sponsor
|
| Name |
Dr Nandani Tiwari |
| Address |
Room number 13, Dept of Public Health Dentistry, Government College of Dentistry, Indore, MP, India , Pin code : 452001 |
| 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 |
| Dr Nandani Tiwari |
Government College of Dentistry, Indore |
Room number 13, Dept of Public Health Dentistry , Indore, Govt College of Dentistry, Indore
Indore
MADHYA PRADESH |
7020926675
nandyt18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,GDC ,Indore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 Atraumatic restorative treatment with 38% SDF application.
Group 2 Conventional GIC restoration with 38% SDF application |
In Group 1 after caries excavation , 38% Sliver diamine fluoride will be applied to arrest caries over which GIC restoration will be done using ART and will be followed for 7 days . 30 days , 3 months and 6 months to evaluate survival of restoration and arrest of caries.
In Group 2 after caries excavation , 38% Sliver diamine fluoride will be applied to arrest caries over which conventional GIC restoration will be done and will be followed for 7 days . 30 days , 3 months and 6 months to evaluate survival of restoration and arrest of caries. |
| Comparator Agent |
Group 3 Atraumatic Restorative Treatment without 38% SDF application.
Group 4 Conventional GIC restoration without 38% SDF application |
In Group 3 after caries excavation , 38% Sliver diamine fluoride will not be be applied to arrest caries over which only GIC restoration will be done using ART and will be followed for 7 days . 30 days , 3 months and 6 months to evaluate survival of restoration and arrest of caries.
In this Group 4 after caries excavation , 38% Sliver diamine fluoride will not be applied to arrest caries, only conventional GIC restoration will be done and will be followed for 7 days . 30 days , 3 months and 6 months to evaluate survival of restoration and arrest of caries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Any individuals, between the age of 18 to 65 years, with Class 1 occlusal caries of posterior teeth, without involving the pulp.
2.Patients who are willing to attend the follow-up visit as required for the study.
3.Patients understand the significance of SDF for the treatment and prevention of tooth decay and giving consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients with developmental abnormalities of enamel and dentin.
2.Patient with systemic illness.
3.Patients with known silver allergic reactions.
4.Pulp-exposed tooth, or any kind of iatrogenic deep dentinal pulpal exposure.
5.Pregnant and lactating women will not be included in study.
6.Patients with symptomatic oral mucosal lesions.
7.Patients with periodontal disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of survival of the restoration clinically using criteria and codes on follow up of 7th, 30th days , 3 months , 6 months.
And at the end of 6th month radiograph taken to assess the caries arrest using baseline radiograph will be done. |
Analysis of survival rate and caries arrest in 4 groups will be compared at baseline, 7 days, 30 days , 3 months and 6 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the cost effectiveness after completion of study |
After 6 months , 1 year |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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 4 |
|
Date of First Enrollment (India)
|
12/08/2024 |
| 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="2"
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 - NO
|
|
Brief Summary
|
This novel approach brings together the capability of Silver Diamine Fluoride (SDF) to kill bacteria with that of Glass ionmer cement (GIC) restoration to seal the tooth and cut off nutrients needed for bacterial growth. As SDF could enhance cariostatic action and prolong the survival of restoration in oral health care settings for resource management in cost effective way. To evaluate clinical performance and longevity of SDF applied GIC restorations and assess survival rate using ART and conventional GIC method over a period of 6 months for prevention and arrest of caries. Parallel arm RCT will be conducted - the patients will be randomized into 4 groups and accordingly intervention will be given. The follow up will be done for 6 months. Individual between 18 to 65 years with class 1 caries of the permanent posterior teeth. Study will be conducted at department of Public Health Dentistry Government college of dentistry , Indore, India. |