- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04196829
Staining Potential and Caries Arresting Effect of Silver Diamine Fluoride⁄Potassium Iodide and Silver Diamine Fluoride
September 2, 2021 updated by: Mariam Mohsen Aly, Cairo University
Comparative Evaluation of Staining Potential and Caries Arresting Effect of Silver Diamine Fluoride⁄Potassium Iodide and Silver Diamine Fluoride in Carious Primary Anterior Teeth
the main objective of this study is to evaluate staining potential and Caries Arresting Effect of silver diamine fluoride⁄potassium Iodide and silver diamine fluoride in carious anterior primary teeth
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Despite increased attention on caries prevention, not all children receive preventive treatments and large numbers still experience tooth decay.
Primary care providers have had little option other than invasive and costly specialist treatment in the hospital under general anesthesia.
In this context, there is interest in simple treatments to halt progress of carious lesions after tooth decay onset.
Among these simple treatments is silver diamine fluoride (SDF) treatment.
The major drawback to SDF treatment has been its black staining, which has limited its use.
To counter the staining, researchers have tested SDF treatment immediately followed with application of saturated solution of potassium iodide (KI).
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 3 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children with carious primary anterior teeth.
- Children with no spontaneous pain
Exclusion Criteria:
- Tooth mobility
- Signs of pulpal or periapical infection
- Severe medical conditions that would not allow management in the clinic
- Sensitivity to silver or other heavy-metal ions
- Presence of any gingival or perioral ulceration or stomatitis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: silver diamine fluoride ⁄ potassium Iodide
38% silver diamine fluoride and a saturated solution of potassium iodide
|
The affected tooth surface will be gently cleaned and dried with cotton gauze.
The gingival tissue of the tooth will be protected with petroleum jelly.
An applicator will be dipped into the SDF and 3-4 mg applied to the lesion with microbrush which will be used to paint solution over carious lesion then we will wait for 1 minute till absorption .
Then after SDF application KI will be applied using a separate microbrush which will be saturated by the solution and will be used to paint solution over carious lesion , no rinse will be performed and special instructions will be given following application
Other Names:
|
Active Comparator: silver diamine fluoride
38% silver diamine fluoride
|
The affected tooth surface will be gently cleaned and dried with cotton gauze.
The gingival tissue of the tooth will be protected with petroleum jelly.
An applicator will be dipped into the SDF and 3-4 mg applied to the lesion with microbrush which will be used to paint solution over carious lesion then we will wait for 1 minute till absorption .
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
staining potential
Time Frame: base line and Immediately after material application
|
change in color of carious lesion using spectrophotometer with unit of measurement percent
|
base line and Immediately after material application
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
caries arresting effect
Time Frame: 3 months, 6 moths, 9 months, 12 months
|
evaluating hardness of carious lesion by tactile examination using probe, binary (soft or hard)
|
3 months, 6 moths, 9 months, 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post operative pain
Time Frame: 3 months, 6 moths, 9 months, 12 months
|
asking the patient, Binary (present or absent)
|
3 months, 6 moths, 9 months, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mariam Aly, Phd, Lecturer, Faculty of Dentistry, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2020
Primary Completion (Actual)
August 12, 2021
Study Completion (Anticipated)
October 1, 2021
Study Registration Dates
First Submitted
December 8, 2019
First Submitted That Met QC Criteria
December 10, 2019
First Posted (Actual)
December 12, 2019
Study Record Updates
Last Update Posted (Actual)
September 10, 2021
Last Update Submitted That Met QC Criteria
September 2, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDF staining potential
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dental Caries in Children
-
Stephanie ShimizuUniversity of Southern CaliforniaRecruitingDental Caries in Children | Dental Caries | Dental Caries Class IIUnited States
-
Oral Health Centre of Expertise in Eastern NorwayPublic Dental Service, Hedmark; Public Dental Service, Oppland; Public Dental...Active, not recruitingDental Caries in Children | Dental Caries Pit and FissureNorway
-
Children's Hospital ColoradoRecruitingDental Caries in Children | Dental DiseasesUnited States
-
University of GlasgowMinistry of Health, Saudi ArabiaRecruiting
-
University of Sao PauloNot yet recruitingDental Caries in Children | Dental CariesBrazil
-
Suez Canal UniversityCompletedDental Caries in ChildrenEgypt
-
Advantage Silver Dental Arrest, LLCActive, not recruitingDental Caries in ChildrenUnited States Minor Outlying Islands
-
Al-Azhar UniversityActive, not recruitingDental Caries in ChildrenEgypt
-
Ahram Canadian UniversityCompletedDental Caries in ChildrenEgypt
-
TC Erciyes UniversityCompleted
Clinical Trials on silver diamine fluoride ⁄ potassium Iodide
-
Nourhan M.AlyAlexandria UniversityCompletedIndirect Pulp Capping | Tertiary DentineEgypt
-
Cairo UniversityRecruiting
-
Federal University of the Valleys of Jequitinhonha...UnknownDental Caries in ChildrenBrazil
-
Advantage Dental Services, LLCCompleted
-
University of ManitobaChildren's Hospital Research Institute of ManitobaCompletedEarly Childhood CariesCanada
-
Dina Bassam Mohamed AhmedCompleted
-
The University of Hong KongCompleted
-
University of MichiganUniversity of Iowa; NYU Langone Health; National Institute of Dental and Craniofacial...CompletedCavities of TeethUnited States
-
Ain Shams UniversityCompleted