| CTRI Number |
CTRI/2024/08/072965 [Registered on: 23/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare and evaluate the various caries removal methods followed by the application of Silver Diamine Fluoride |
|
Scientific Title of Study
|
Comparative Evaluation of Selective Caries Removal Techniques Followed by SDF Application In Primary Molars - An In Vivo 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 |
Dr Meenu Bhola |
| Designation |
Professor and Head |
| Affiliation |
Baba Farid University of health sciences, Faridkot |
| Address |
Dasmesh Institute of Research and Dental Sciences, talwandi Road, Faridkot
Faridkot PUNJAB 151203 India |
| Phone |
9888023400 |
| Fax |
|
| Email |
meenubhola@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shreya |
| Designation |
Post-graduate Student |
| Affiliation |
Baba Farid University of health sciences, Faridkot |
| Address |
Dasmesh Institute of Research and Dental Sciences, talwandi Road, Faridkot
Faridkot PUNJAB 151203 India |
| Phone |
9877380938 |
| Fax |
|
| Email |
dr.shreyagargg@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shreya |
| Designation |
Post-graduate Student |
| Affiliation |
Baba Farid University of health sciences, Faridkot |
| Address |
Dasmesh Institute of Research and Dental Sciences, talwandi Road, Faridkot
Faridkot PUNJAB 151203 India |
| Phone |
9877380938 |
| Fax |
|
| Email |
dr.shreyagargg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dasmesh Institue of Research and Dental Sciences, Talwandi Road, Faridkot, Punjab, India
pincode 151203 |
|
|
Primary Sponsor
|
| Name |
Dr Shreya |
| Address |
Dasmesh Institute of Research and Dental Sciences, talwandi Road, Faridkot, Punjab, India
pincode 151203 |
| 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 Shreya |
Dasmesh Institue of Research and Dental Sciences, Talwandi Road, Faridkot |
Department of Pediatric and Preventive Dentistry Faridkot PUNJAB |
9877380938
dr.shreyagargg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caries removal using chemo-mechanical caries removing agent followed by SDF application and GIC restoration |
The chemo-mechanical caries removing gel (Dengen Dental Carie Fix Caries
Removing Gel) will be applied to the lesion. After 30 seconds (as per the manufacturer’s instructions), the gel will be removed using a moistened cotton pellet, and softened carious dentin will be removed using a spoon excavator. If necessary, a second application can be performed in areas where the caries are hard, to soften the caries for easier removal. Once again, the gel will be removed using a moistened cotton pellet and the remaining caries will be excavated using a spoon excavator. Caries excavation will be considered complete when no caries can be detected with tactile method. |
| Comparator Agent |
Caries removal using Hand Instruments followed by SDF application and GIC restoration |
The affected tooth will be visually inspected or probed, to determine the extent of decay. Then, the caries will be excavated using a sharp spoon excavator in gentle scraping motions to scoop out the soft, decayed dentin. Caries excavation will be considered complete when no caries can be detected with tactile method |
| Intervention |
Caries removal using polymer bur followed by SDF application and GIC restoration |
Caries will be excavated using polymer bur (SS White Smart Burs II). The polymer bur will be mounted on a low-speed contra-angled handpiece. Caries will be removed in a circular motion starting from the centre of the lesion towards the periphery. Caries removal will continue until polymer bur becomes dull after repeated contact with healthy dentin and becomes visibly abraded and blunt. Cutting will be done till no more softened dentin is present. Additional polymer burs can be used until caries are completely removed. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.Children with written informed consent
2.Healthy children from 4 to 8 years of age
3.Cooperative child
4.Children with asymptomatic carious lesions in primary molars extending into the dentin (ICDAS score 4 OR 5)
5.Teeth that are restorable
6.No clinical evidence of pulpal degeneration (pain on percussion, history of swelling, sinus tract) |
|
| ExclusionCriteria |
| Details |
1.Uncooperative children
2.Medically compromised patients
3.Teeth with a history of spontaneous pain or pulpal degeneration
4.Grossly decayed teeth
5.Teeth with radiographic signs of internal / external resorption or furcation involvement
6.Teeth near physiological exfoliation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To clinically and radiographically evaluate the efficacy of caries removal using hand instruments,chemo-mechanical caries removing agent, and smart burs followed by SDF application and GIC restoration in deep carious primary molars.
|
evaluation will be done immediately after procedure and at 1, 3, 6, and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time taken to complete procedure |
immediately after procedure |
| pain perception by patient using Wong Baker FACES Pain Rating Scale |
immediately after procedure |
| Score for Caries Excavation based on Ericson D et al. Criteria (1999) |
at baseline |
| clinical evaluation : pain (on percussion), fistula, sinus opening & pathological mobility |
at baseline, 1 month, 3 months, 6 months & 9 months
|
| radiogarphic evaluation for pathologica root resorption, normal periodontal ligament space & absence of periapical and/or bifurcation radiolucency |
at baseline, 1 month, 3 months, 6 months & 9 months |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/09/2024 |
| 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="2" Months="0" 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.shreyagargg@gmail.com].
- For how long will this data be available start date provided 04-01-2025 and end date provided 04-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Preoperative clinical and radiographic examinations will be done to ensure proper case selection. The involved tooth will be isolated with cotton rolls and a saliva ejector. The working time will be calculated from the beginning of caries excavation in all three groups, using a stopwatch. GROUP I (Caries removal using Hand Instruments followed by SDF application): The affected tooth will be visually inspected or probed, to determine the extent of decay. Then, the caries will be excavated using a sharp spoon excavator in gentle scraping motions to scoop out the soft, decayed dentin. Caries excavation will be considered complete when no caries can be detected with tactile method. GROUP II (Caries removal using chemo-mechanical caries removing agent followed by SDF application): The chemo-mechanical caries removing gel (Dengen Dental Carie Fix Caries Removing Gel) will be applied to the lesion. After 30 seconds (as per the manufacturer’s instructions), the gel will be removed using a moistened cotton pellet, and softened carious dentin will be removed using a spoon excavator. If necessary, a second application can be performed in areas where the caries are hard, to soften the caries for easier removal. Once again, the gel will be removed using a moistened cotton pellet and the remaining caries will be excavated using a spoon excavator. Caries excavation will be considered complete when no caries can be detected with tactile method. GROUP III (Caries removal using polymer bur followed by SDF application): Caries will be excavated using polymer bur (SS White Smart Burs II). The polymer bur will be mounted on a low-speed contra-angled handpiece. Caries will be removed in a circular motion starting from the centre of the lesion towards the periphery. Caries removal will continue until polymer bur becomes dull after repeated contact with healthy dentin and becomes visibly abraded and blunt. Cutting will be done till no more softened dentin is present. Additional polymer burs can be used until caries are completely removed. Caries excavation will be evaluated using Ericson D et al. scale (1999). Caries excavation will be followed by the application of 38% Silver Diamine Fluoride solution (FAgamin). It will allow the removal of gross debris, allowing SDF to be in maximum contact with the affected dentin surface. Before the application of SDF, a protective coating of petroleum jelly will be applied to surrounding soft tissues to avoid their discoloration. One drop of SDF will be placed in a plastic dappen dish and will be applied to the excavated area with an applicator tip for 1 minute, using a gentle flow of compressed air until the liquid is dry. The remaining tooth structure will be restored with GC Gold Label Universal Restorative Cement. Time taken in caries excavation followed by SDF application during each procedure will be compared. Patient acceptance will be assessed using the Wong-Baker Faces Pain Scale which can easily be understood by children as it consists of a series of faces depicting different levels of pain, ranging from a smiling face representing “no hurt†with a score of 0 and to a crying face indicating “hurts worst†with a score of 10. After the completion of the treatment, patients will be recalled after 1, 3, 6, and 9 months. Clinical and radiographic outcomes of the procedure will be recorded during each visit. |