Clinical Evaluation of SDF Combined With KI Versus SDF in Management of Class I Carious Lesions

Clinical Evaluation of Silver Diamine Fluoride Combined With Potassium Iodide Versus Silver Diamine Fluoride in Management of Class I Carious Lesions Over a Period of 12 Months Follow-up: A Randomized Controlled Clinical Trial

To evaluate the clinical performance of High-Viscosity Glass Ionomer (EQUIA) versus Silver Diamine Fluoride combined with Potassium Iodide (Riva Star) and Sliver Diamine Fluoride (SDF) under High-Viscosity Glass Ionomer (EQUIA) in deep class I carious lesions, over a period of one year follow-up. The null hypothesis tested in this study, that in deep class I carious lesions, the High-Viscosity Glass Ionomer (EQUIA) versus Silver Diamine Fluoride combined with Potassium Iodide (Riva Star) and Sliver Diamine Fluoride (SDF) under High-Viscosity Glass Ionomer (EQUIA) will show the same clinical performance.

Study Overview

• Status: Recruiting
• Conditions: Carious Lesion
• Intervention / Treatment: Other: Silver Diamine Fluoride combined with Potassium Iodide.; Other: Silver Diamine Fluoride.; Other: High-Viscosity Glass Ionomer.

Detailed Description

A sample of adults with an age range of 18-40 years old, having a permanent molar with deep class I carious lesions, according to the international caries detection and assessment system (ICDAS), occlusal caries that scored 4 (underlying dark shadow from dentin), or 5 (Distinct cavity with visible dentin), will be selected from the patients attending at the Conservative and Esthetic Dentistry Department Clinic, Faculty of Dentistry, Cairo University, and those who meet the study inclusion criteria will be recruited.

All selected 42 permanent molars will be randomly equally allocated into three groups according to the material used. Group I (n=14) Silver Diamine Fluoride combined with Potassium Iodide (Riva Star) under High-Viscosity Glass Ionomer (EQUIA), Group II (n=14) Silver Diamine Fluoride (SDF) both under High-Viscosity Glass Ionomer (EQUIA), and Group III (n=14) High-Viscosity Glass Ionomer (EQUIA).

Steps in Short:

1. Recruitment of the patients and full examination with diagnosis.
2. Informed consent taking for the eligible participants to participate in the study.
3. Randomization and allocation into three groups.
4. Application of the intervention 1; Silver Diamine Fluoride combined with Potassium Iodide (Riva Star). Intervention 2; Silver Diamine Fluoride (SDF). Both under High-Viscosity Glass Ionomer (EQUIA). The comparator; High-Viscosity Glass Ionomer (EQUIA). All materials were manipulated according to the manufacturers' instructions.
5. Baseline data collection of the clinical evaluation of the restorations using FDI criteria.
6. Follow up at 3, 6, and 12 months for data collection of the clinical evaluation of the restorations using FDI criteria.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shorouk H Helmy, Master's; Phone Number: 00201015775110; Email: shorouk.helmy@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of Dentistry, Cairo University
    • Contact: Shorouk H Helmy, Master's; Phone Number: 00201015775110; Email: shorouk.helmy@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with deep class I carious lesions in molars, according to the international caries detection and assessment system (ICDAS), occlusal caries that scored 4 (underlying dark shadow from dentin), or 5 (Distinct cavity with visible dentin).
2. Adults males or females.
3. Age: 18-40 years old.
4. Good Oral hygiene.
5. Co-operative patients, approving to participate in the study.
6. Teeth planned to be restored should be vital.
7. Presence of favorable occlusion.

Exclusion Criteria:

1. Patients having severe systemic diseases, allergies, or adverse medical histories.
2. Patients complaining of sever or active periodontal disease.
3. Lack of compliance.
4. Teeth diagnosed with irreversible pulpitis.
5. Non vital teeth.
6. Heavy occlusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention 1; Silver Diamine Fluoride combined with Potassium Iodide (Riva Star), under High-Viscosity Glass Ionomer (EQUIA).	Other: Silver Diamine Fluoride combined with Potassium Iodide.; Riva Star, Silver diamine fluoride 38% and potassium iodide, SDI, Bayswater, Australia.; Other Names: Riva Star.
Experimental: Intervention 2; Silver Diamine Fluoride (SDF), under High-Viscosity Glass Ionomer (EQUIA).	Other: Silver Diamine Fluoride.; A clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride.; Other Names: SDF.
Active Comparator: The comparator; High-Viscosity Glass Ionomer (EQUIA).	Other: High-Viscosity Glass Ionomer.; A Glass Hybrid material.; Other Names: EQUIA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological Properties: (Postoperative hyper-sensitivity)	will be ranked according to Federation Dentaire Internationale criteria (FDI). Scoring system (1,2,3,4,5) by patient interviewing	12 Months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Properties: (Radiographic examination and Patient's view) (Radiographic examination, and Patient's view)	will be ranked according to Federation Dentaire Internationale criteria (FDI). Scoring system (1,2,3,4,5) by standardized periapical digital radiographs taken by parallel technique and by patient interviewing	12 months.
Esthetic: Tooth Color	by Easy Shade. measuring unit: ΔE	12 months.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Shorouk H Helmy, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): September 10, 2022
• Study Completion (Anticipated): March 2, 2023

Study Registration Dates

• First Submitted: July 30, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: 14422019469442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: after 1 year.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No