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

NCT04196829 | Unknown Phase 4

• 1 other identifier: SDF staining potential
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

• staining potential

  change in color of carious lesion using spectrophotometer with unit of measurement percent

  base line and Immediately after material application

Secondary Outcomes (1)

• caries arresting effect

  3 months, 6 moths, 9 months, 12 months

Other Outcomes (1)

• post operative pain

  3 months, 6 moths, 9 months, 12 months

Study Arms (2)

silver diamine fluoride ⁄ potassium Iodide

EXPERIMENTAL

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

Drug: silver diamine fluoride ⁄ potassium Iodide

silver diamine fluoride

ACTIVE COMPARATOR

38% silver diamine fluoride

Drug: Silver Diamine Fluoride

Interventions

silver diamine fluoride ⁄ potassium Iodide 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

Also known as: SDF / KI

silver diamine fluoride ⁄ potassium Iodide

Silver Diamine Fluoride 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 .

Also known as: SDF

silver diamine fluoride

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children with carious primary anterior teeth.
• Children with no spontaneous pain

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

silver diamine fluoride

Study Officials

• Mariam Aly, Phd

  Lecturer, Faculty of Dentistry, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in pediatric dentistry and dental public health, faculty of dentistry, Cairo university

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: December 12, 2019
• Study Start: January 2, 2020
• Primary Completion: August 12, 2021
• Study Completion: October 1, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Locations

EG (1)