Staining Potential and Caries Arresting Effect of Silver Diamine Fluoride⁄Potassium Iodide and Silver Diamine Fluoride

NCT ID: NCT04196829

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2021-10-31

Brief Summary

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

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).

Conditions

Dental Caries in Children

Study Design

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

Study Groups

silver diamine fluoride ⁄ potassium Iodide

38% silver diamine fluoride and a saturated solution of potassium iodide

Group Type: EXPERIMENTAL

silver diamine fluoride ⁄ potassium Iodide

Intervention Type: DRUG

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

silver diamine fluoride

38% silver diamine fluoride

Group Type: ACTIVE_COMPARATOR

Silver Diamine Fluoride

Intervention Type: DRUG

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 .

Interventions

silver diamine fluoride ⁄ 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

Intervention Type: DRUG

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 .

Intervention Type: DRUG

Other Intervention Names

SDF / KI; SDF

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mariam Mohsen Aly

lecturer in pediatric dentistry and dental public health, faculty of dentistry, Cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariam Aly, Phd

Role: PRINCIPAL_INVESTIGATOR

Lecturer, Faculty of Dentistry, Cairo University

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

SDF staining potential

Identifier Type: -

Identifier Source: org_study_id