Comparison of the Potential for Dentine Discoloration of Silver Diamino Fluoride and Silver Diamino Fluoride Associated With Potassium Iodide
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Dentin color change
Study Overview
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.
Detailed Description
Primary Objective:
To compare dentine discoloration in caries lesions in the deciduous dentition after Silver Diamino Fluoride treatment with and without association with Potassium Iodide (PI).
Secondary Objective:
To compare the effectiveness of the methods in the inactivation of active carious lesions Compare the inactivation time of the lesions between the groups Compare the presence of biofilm accumulation in the different comparing the differences in the effectiveness of the methods for inactivation of lesions on different surfaces.
Scratchs:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
Single
Eligibility Criteria
- Ages
- 1 Year to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
Arms & Interventions
Silver Diamine Fluoride
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.
Intervention: Silver Diamine Fluoride with Potassium Iodide (Procedure)
Silver Diamine Fluoride with Potassium Iodide
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.
Intervention: Silver Diamine Fluoride with Potassium Iodide (Procedure)
Outcomes
Primary Outcomes
Dentin color change
Time Frame: 1 week, 15 days, 1 and 2 months
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.
Secondary Outcomes
- 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)