Clinical trial NCT05485272: Clinical Evaluation of SDF Combined With KI Versus SDF in Management of Class I Carious Lesions
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carious Lesion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 3-arm randomized clinical trial. Randomization will be done according to a check list including the number of participants divided into 3 groups of 14 patients (42 total) according to interventions/Control assessment methods.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biological Properties: (Postoperative hyper-sensitivity)
timeFrame: 12 Months.
Secondary outcomes:
measure: Functional Properties: (Radiographic examination and Patient's view) (Radiographic examination, and Patient's view)
timeFrame: 12 months.
measure: Esthetic: Tooth Color
timeFrame: 12 months.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty Of Dentistry, Cairo University
Study officials:
affiliation: Cairo University
name: Shorouk H Helmy
role: PRINCIPAL_INVESTIGATOR
References: