Clinical Evaluation of SDF Combined With KI Versus SDF in Management of Class I Carious Lesions
Primary Purpose
Carious Lesion
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Silver Diamine Fluoride combined with Potassium Iodide.
Silver Diamine Fluoride.
High-Viscosity Glass Ionomer.
Sponsored by
About this trial
This is an interventional treatment trial for Carious Lesion
Eligibility Criteria
Inclusion Criteria:
- 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).
- Adults males or females.
- Age: 18-40 years old.
- Good Oral hygiene.
- Co-operative patients, approving to participate in the study.
- Teeth planned to be restored should be vital.
- Presence of favorable occlusion.
Exclusion Criteria:
- Patients having severe systemic diseases, allergies, or adverse medical histories.
- Patients complaining of sever or active periodontal disease.
- Lack of compliance.
- Teeth diagnosed with irreversible pulpitis.
- Non vital teeth.
- Heavy occlusion.
Sites / Locations
- Faculty Of Dentistry, Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Intervention 1
Intervention 2
The comparator
Arm Description
Silver Diamine Fluoride combined with Potassium Iodide (Riva Star), under High-Viscosity Glass Ionomer (EQUIA).
Silver Diamine Fluoride (SDF), under High-Viscosity Glass Ionomer (EQUIA).
High-Viscosity Glass Ionomer (EQUIA).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Esthetic: Tooth Color
by Easy Shade. measuring unit: ΔE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05485272
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
September 10, 2022 (Anticipated)
Study Completion Date
March 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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:
Recruitment of the patients and full examination with diagnosis.
Informed consent taking for the eligible participants to participate in the study.
Randomization and allocation into three groups.
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.
Baseline data collection of the clinical evaluation of the restorations using FDI criteria.
Follow up at 3, 6, and 12 months for data collection of the clinical evaluation of the restorations using FDI criteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carious Lesion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
The operator will not be blinded due to differences between both materials.
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention 1
Arm Type
Experimental
Arm Description
Silver Diamine Fluoride combined with Potassium Iodide (Riva Star), under High-Viscosity Glass Ionomer (EQUIA).
Arm Title
Intervention 2
Arm Type
Experimental
Arm Description
Silver Diamine Fluoride (SDF), under High-Viscosity Glass Ionomer (EQUIA).
Arm Title
The comparator
Arm Type
Active Comparator
Arm Description
High-Viscosity Glass Ionomer (EQUIA).
Intervention Type
Other
Intervention Name(s)
Silver Diamine Fluoride combined with Potassium Iodide.
Other Intervention Name(s)
Riva Star.
Intervention Description
Riva Star, Silver diamine fluoride 38% and potassium iodide, SDI, Bayswater, Australia.
Intervention Type
Other
Intervention Name(s)
Silver Diamine Fluoride.
Other Intervention Name(s)
SDF.
Intervention Description
A clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride.
Intervention Type
Other
Intervention Name(s)
High-Viscosity Glass Ionomer.
Other Intervention Name(s)
EQUIA
Intervention Description
A Glass Hybrid material.
Primary Outcome Measure Information:
Title
Biological Properties: (Postoperative hyper-sensitivity)
Description
will be ranked according to Federation Dentaire Internationale criteria (FDI). Scoring system (1,2,3,4,5) by patient interviewing
Time Frame
12 Months.
Secondary Outcome Measure Information:
Title
Functional Properties: (Radiographic examination and Patient's view) (Radiographic examination, and Patient's view)
Description
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
Time Frame
12 months.
Title
Esthetic: Tooth Color
Description
by Easy Shade. measuring unit: ΔE
Time Frame
12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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).
Adults males or females.
Age: 18-40 years old.
Good Oral hygiene.
Co-operative patients, approving to participate in the study.
Teeth planned to be restored should be vital.
Presence of favorable occlusion.
Exclusion Criteria:
Patients having severe systemic diseases, allergies, or adverse medical histories.
Patients complaining of sever or active periodontal disease.
Lack of compliance.
Teeth diagnosed with irreversible pulpitis.
Non vital teeth.
Heavy occlusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shorouk H Helmy, Master's
Phone
00201015775110
Email
shorouk.helmy@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shorouk H Helmy
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty Of Dentistry, Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shorouk H Helmy, Master's
Phone
00201015775110
Email
shorouk.helmy@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
after 1 year.
Learn more about this trial
Clinical Evaluation of SDF Combined With KI Versus SDF in Management of Class I Carious Lesions
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