Potential for Dentine Discoloration of Silver Diamino Fluoride Associated With Potassium Iodide

NCT04001959 | Unknown DMC

• 1 other identifier: 04243718.0.0000.5108
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this randomized clinical trial will be the comparison of dentine discoloration after treatment with: Silver Diamino Fluoride and Silver Diamino Fluoride associated with Potassium Iodide for caries lesions in posterior primary teeth. The study sample will consist of children presenting caries lesion in dentin, without reporting spontaneous pain. The children will be allocated into 2 groups that will correspond to the treatments with the use of SDF (Group 1), SDF + PI (Group 2). Treatment will be performed by trained and calibrated researchers. Examiners will be blind to the treatment received. Initially, data will be collected on socio-demographic aspects, characteristics of children, and clinical aspects. Clinical, photographic and initial evaluations will be performed after 1 week, 15 days, 1 and 2 months after treatment. The results obtained will be typed and organized in a database, using the software Statistical Package for Social Science (SPSS), version 22.0 and descriptive, bivariate analyzes will be performed.

Conditions

Dental Caries in Children

Keywords

Carostats; Clinical trial; Preventive dentistry; Preschoolers

Outcome Measures

Primary Outcomes (1)

• Dentin color change

  In all the consultations will be made photographic shoots of the tooth with purpose of comparison. Then all images will be downloaded to the computer and analyzed using the Windows program - Paint. The tooth will be analyzed on all its faces. The coloration will be evaluated in scores from 0 to 4 where 0 is white, 1 yellow, 2 light brown, 3 dark brown and 4 black.

  1 week, 15 days, 1 and 2 months

Secondary Outcomes (2)

• Clinical success based on the International System for Assessment and Detection of Caries (ICDAS)

  1 and 2 months

• Parental Satisfaction Scale

  1 and 2 months

Study Arms (2)

Silver Diamine Fluoride

ACTIVE COMPARATOR

Initially a prophylaxis will be done on the tooth to be treated with Robinson brush and prophylactic paste and then the relative isolation (with mouth openers and cotton rollers) and protection of the soft tissues with vaseline in the region to be treated to protect the surrounding tissues will be carried out. Next, dry the tooth for 30 seconds with air jet followed by a drop of 30% Diamino Fluoride Silver with a disposable applicator brush for 3 minutes and after that time washing for 1 minute.

Procedure: Silver Diamine Fluoride with Potassium Iodide

Silver Diamine Fluoride with Potassium Iodide

EXPERIMENTAL

Initially a prophylaxis will be done on the tooth to be treated with Robinson brush and prophylactic paste and then the relative isolation (with mouth openers and cotton rollers) and protection of the soft tissues with vaseline in the region to be treated to protect the surrounding tissues will be carried out. Then the tooth is dried for 30 seconds with an air jet and applied one drop of the Diamino 30% Silver Fluoride with a disposable applicator brush for 3 minutes and one drop of potassium iodide solution immediately on the surface treated with Diamino , until the formed creamy white color becomes transparent. After these steps have been completed, rinse with water for 1 minute.

Procedure: Silver Diamine Fluoride with Potassium Iodide

Interventions

Silver Diamine Fluoride with Potassium Iodide PROCEDURE

Dry the tooth for 30 seconds with air jet and apply one drop of Diamino 30% Silver Fluoride with a disposable applicator brush for 3 minutes and one drop of potassium iodide solution immediately on the treated surface, then wash.

Silver Diamine Fluoride; Silver Diamine Fluoride with Potassium Iodide

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children who have at least one vital deciduous tooth with a dentin cavitated lesion.
• Children whose parents / guardians agree to their child's participation in the study.

You may not qualify if:

• Child with systemic health impairment;
• Child who has already performed dental treatment on the tooth to be included in the research;
• Sensitivity to chemicals used;
• Tooth with spontaneous pain;
• Tooth with pulp wrapping;
• Radiographic evidence of pathological internal or external resorption of the root;
• Radiographic evidence of periapical lesion;

Sponsors & Collaborators

• Federal University of the Valleys of Jequitinhonha and Mucuri: lead

Study Sites (1)

Priscila Seixas Mourão

Diamantina, Minas Gerais, 39.100-00, Brazil

RECRUITING

MeSH Terms

Interventions

silver diamine fluoride; Potassium Iodide

Intervention Hierarchy (Ancestors)

Iodides; Iodine Compounds; Inorganic Chemicals; Potassium Compounds

Central Study Contacts

Priscila S Mourão, Graduated

CONTACT

+5538998262283; priscila.smourao@gmail.com

Marcos L Pinheiro, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Single
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, controlled study in which the variables were evaluated 1 week, 15 days, 1 and 2 months after the intervention. For the allocation of participants, a Randomization ratio of 1: 1 was performed.

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 28, 2019
• Study Start: May 2, 2019
• Primary Completion: July 1, 2019
• Study Completion: September 1, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)