Evaluation Of Fluoride Uptake By Dentine Following Silver Diamine Fluoride Under Resin Modified Glass Ionomer Restoration In Carious Primary Molars

NCT ID: NCT04777968

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-02-01

Brief Summary

Dental caries is one of the most common oral diseases of childhood and is considered as a major public health problem especially in areas with poor access to dental care. In a recent cross sectional study carried out in Egypt on 1000 child aged from 3-6 years, it was found that 61.4% of these children had dental caries. In order to avoid serious complications of untreated dental caries such as pain, infections, emergency visits and possibly hospitalization , an effective low cost treatment should be identified particularly in areas with poor dental access.

Studies have proven that silver diamine fluoride (SDF) is a topical fluoride that has the ability to effectively arrest and prevent dental caries.

Detailed Description

It was concluded that fluoride uptake into dentine from conventional GI restorations was not affected in the presence of SDF and KI. It was also mentioned that the results may be different if conditioning is applied not etching and recommended this for future investigation.

Aim: Therefore, the aim of this study is to determine whether carious primary molars treated with SDF and Potassium iodide (KI) prior to placing resin modified glass ionomer (RMGI) restorations will affect the fluoride uptake into primary dentine or not.

Study Setting:

• The study was conducted in Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry, Cairo University, Egypt.
• Energy Dispersive X-ray analysis with Scanning Electron Microscope (SEM/EDX) measurement analysis was conducted at the National Research Center (NRC), Egypt.

Freshly extracted discarded primary molars were collected from outpatient clinic of Pediatric Dentistry Department, Faculty of Dentistry, Cairo University at the end of every day.

• Teeth were then sectioned through the center of the carious lesion mesiodistally using a slow-speed cutting saw with coolant (Isomet 4000, USA) forming two similar halves, so that the 20 molars were sectioned to 40 halves.
• Each tooth was placed in a separate container with its 2 halves.
• Teeth containers were then randomly allocated either to the control or intervention group.

Control Group: One half empty and the other half with Resin Modified Glass Ionmer (RMGI) only.

Intervention Group : One half empty and the other half SDF+KI+RMGI

• After dehydration, teeth were mounted on stubs using double-sided carbon tape, and sputter coated with gold for 20 s using a Turbo molecular pumped coater (QUORUM 150T ES, Laughton, United Kingdom) .
• Teeth were then placed in SEM/EDX for fluoride measurement by weight percentage.

Data showed parametric distribution so; it was represented by mean and standard deviation (SD) values. Independent and paired t-tests were used for inter and intragroup comparisons respectively. The significance level was set at p ≤0.05 within all tests. Statistical analysis was performed with R statistical analysis software version 4.0.3 for windows (R Core Team, 2020).

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group (A) : RMGI restoration without SDF and KI.

• RMGI restoration without SDF and KI.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group (B): Pretreatment with SDF and KI prior to RMGI restoration.

• Pretreatment with SDF and KI prior to RMGI restoration.

Group Type: EXPERIMENTAL

Silver diamine fluoride

Intervention Type: DRUG

a layer of 38% SDF solution was topically applied to the cavity using a micro brush, immediately followed by a saturated Potassium Iodide KI solution using a micro brush also, then a creamy white precipitate was immediately formed, KI was applied until the white precipitate turned clear.

Interventions

Silver diamine fluoride

a layer of 38% SDF solution was topically applied to the cavity using a micro brush, immediately followed by a saturated Potassium Iodide KI solution using a micro brush also, then a creamy white precipitate was immediately formed, KI was applied until the white precipitate turned clear.

Intervention Type: DRUG

Other Intervention Names

SDF and KI

Eligibility Criteria

Inclusion Criteria

• • Carious primary extracted molars.

• Presence of occlusal or proximal caries.
• Caries extending to dentine.

Exclusion Criteria

• • Presence of restorations.

• Presence of pit and fissure sealant.
• Hypolpastic teeth.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Associate Professor Dr. Rania Abdallah Nasr

Associate Professor Dr. Rania Nasr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rania Nasr, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Cairo University, Egypt

Locations

Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University

Cairo, , Egypt

Faculty of Dentistry, Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

19739

Identifier Type: -

Identifier Source: org_study_id