Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04710927
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2020-12-27
Brief Title:
Silver Diamine Fluoride and Papain-Based Gel for Management of MIH-affected Molar in Paediatric Patients
Sponsor:
University of Malaya
Organization:
University of Malaya
Study Overview
Official Title:
The Use of Silver Diamine Fluoride and Papain-Based Gel for Management of MIH-affected Molar in Paediatric Patients A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Molar incisor hypomineralization MIH is a developmental defect of enamel affecting the first permanent molar and frequently the incisors with a prevalence of 16-169 in Malaysia They presented with many problems such as hypersensitivity increase susceptibility of caries need for recurrent complex dental treatment and difficulty to achieve pain control Silver Diamine Fluoride is a new form of topical fluoride that has been extensively used and recommended for the management of caries in children and adolescents The influence of organic material removal from artificial dentine lesions by means of surface pre-treatment with deproteinizing agent show favoring result of its use on subsequent remineralization with and without fluoride The purpose of this trial is to study the clinical outcome of SDF and papain based gel on hypomineralized teeth restored with HVGIC
Detailed Description:
This is a three-arm parallel randomized controlled trial and will be performed in participants between the age of 5 to 15 years presented with hypomineralised molar of MIH in origin
Clinical assessment radiograph and photographs will be taken for assessment Patients that fulfilled the inclusion criteria will be invited to the study After that the patient will be explained and a Patient Information Sheet PIS will be given Once consent obtained and the patient randomly allocated for the treatment group treatment will be done as below
For group 1 any caries if present will be removed using a hand instrument The tooth then will be filled with High Viscous Glass Ionomer Cement HVGIC following the manufacturers instruction If the participant is assigned to group 2 after caries has been removed using a hand instrument silver diamine fluoride SDF will be applied for 1 minute on the affected area prior to restoration with HVGIC following the manufacturers instruction If the participant is assigned to group 3 papain-based gel Papacare Duo will be applied as a deproteinizing agent caries will be removed using a hand instrument if present Then silver diamine fluoride will be applied for 1 minute on the affected area prior to restoration with HVGIC following the manufacturers instruction
The patient will be followed up after 6 and 12 months The teeth and restoration will be assessed clinically by an assessor that is not involved in the provision of treatment Sign and symptom of pain tenderness to percussion presence of swelling or fistula the scale of sensitivity using Schiff Cold Air Sensitivity Scale SCASS quality if restorative assessment using Atraumatic Restorative Treatment ART Index
Clinical assessment radiograph and photographs will be taken for assessment Patients that fulfilled the inclusion criteria will be invited to the study After that the patient will be explained and a Patient Information Sheet PIS will be given Once consent obtained and the patient randomly allocated for the treatment group treatment will be done as below
For group 1 any caries if present will be removed using a hand instrument The tooth then will be filled with High Viscous Glass Ionomer Cement HVGIC following the manufacturers instruction If the participant is assigned to group 2 after caries has been removed using a hand instrument silver diamine fluoride SDF will be applied for 1 minute on the affected area prior to restoration with HVGIC following the manufacturers instruction If the participant is assigned to group 3 papain-based gel Papacare Duo will be applied as a deproteinizing agent caries will be removed using a hand instrument if present Then silver diamine fluoride will be applied for 1 minute on the affected area prior to restoration with HVGIC following the manufacturers instruction
The patient will be followed up after 6 and 12 months The teeth and restoration will be assessed clinically by an assessor that is not involved in the provision of treatment Sign and symptom of pain tenderness to percussion presence of swelling or fistula the scale of sensitivity using Schiff Cold Air Sensitivity Scale SCASS quality if restorative assessment using Atraumatic Restorative Treatment ART Index
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None