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A study to assess the effectiveness of a silver and fluoride containing re-mineralizing agent on arresting the progression of tooth decay.

Phase 3
Conditions
Health Condition 1: K025- Dental caries on pit and fissure surfaceHealth Condition 2: K026- Dental caries on smooth surface
Registration Number
CTRI/2021/12/038816
Lead Sponsor
Amrita School of dentistry
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Male or Female individuals, between the age of 18 to 65 years, with either one of these caries: Class 1 Caries (only occlusal surface involved in posterior teeth) or Class 2 Caries (occlusal and proximal surface of posterior teeth), without involving the pulp.

2. Patients understand the significance of SDF and ART treatment to prevent tooth decay.

3. Patients are willing to attend the follow up visits as required for the trial.

4. The Patient will be enrolled irrespective of special needs if the subject is willing and able to comply with all the trial requirements.

5. Patients with absence of periodontal disease.

Exclusion Criteria

1. Patient with stomatitis or ulcerative gingivitis.

2. Developmental abnormalities of enamel and dentin.

3. Serious non-communicable medical conditions including cardiac failure, poor glycaemic control.

4. Cavitated teeth missing greater than a third of the coronal tooth structure or having pulpal involvement. The pulp exposed tooth, obvious discoloration, premature hypermobility, and presence of a periapical abscess or a sinus, will be regarded as a tooth with pulpal involvement.

5. Known silver allergy.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The objective of the clinical trial is to compare the effect of application of 38% SDF along with atraumatic restorative treatment against atraumatic restorative treatment alone in arresting active occlusal carious lesions on permanent teeth. It also intends to compare the survival of the restoration.Timepoint: 7th day, 30th day and 180th day
Secondary Outcome Measures
NameTimeMethod
patient satisfaction, and acceptability of the application of the SDF.Timepoint: 7th day, 30th day and 180th day
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