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

Phase 3

Recruiting

Conditions: Dental caries on pit and fissure surface, (2) ICD-10 Condition: K026||Dental caries on smooth surface,

Brief Summary: A randomized controlled trial with parallel design was adopted to compare the effectiveness of application of 38% silver diamine fluoride with atraumatic restorative treatment in cavitated permanent teeth to atraumatic restorative treatment. The study population consist of 220 adult patients from Dental college between the age group of 18 to 65 years. Each participant will be randomly allocated to either the intervention group or the control group on a computer based random generation method. The intervention arm includes the application of 38% SDF along with ART. The statistical analysis will be done using chi-squared test and Kaplan-Meier survival analysis will be conducted on the censored data for survival of the restoration.

Recruitment & Eligibility

Inclusion Criteria

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.
Patients understand the significance of SDF and ART treatment to prevent tooth decay.
Patients are willing to attend the follow up visits as required for the trial.
The Patient will be enrolled irrespective of special needs if the subject is willing and able to comply with all the trial requirements.
Patients with absence of periodontal disease.

Exclusion Criteria

Patient with stomatitis or ulcerative gingivitis.
Serious non-communicable medical conditions including cardiac failure, poor glycaemic control.
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.
Known silver allergy.

Primary Outcome Measures

Name	Time	Method
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.	7th day, 30th day and 180th day

Secondary Outcome Measures

Name	Time	Method
patient satisfaction, and acceptability of the application of the SDF.	7th day, 30th day and 180th day

Locations (1): Amrita School of Dentistry
🇮🇳
Ernakulam, KERALA, India
Amrita School of Dentistry
🇮🇳Ernakulam, KERALA, India
Anju Varughese
Principal investigator
7907431129
ann.wez0306@gmail.com