Clinical evaluation of two composite materials in primary molars

Phase 3

Not yet recruiting

Conditions: Dental caries on pit and fissure surface,

Registration Number: CTRI/2025/05/086641

Lead Sponsor: Dr Mary Verghese

Brief Summary: The title of the study is "A Comparative clinical evaluation of a bioactive restorative material versus bulk- fill composite, for a one year- A randomized clinical trial. The aim of the study is to evaluate the clinical performance of bioactive composite with that of conventional bulk fill composite in class I carious lesion of primary molars at the end of year using FDI criteria. Th objective is to assess the clinical performance i.e. functional, esthetic, and biological properties of bioactive bulk-fill composite restoration with that of the conventional bulk -fill composite restoration in class I carious lesion of primary molars using FDI criteria at the end of one year. It is a double blinded randomized clinical trial which consists of two groups i.e. test group and the control group. The total sample size is 42 teeth, each group consists of 21 teeth. The procedure done for the test group is bioactive bulk fill composite placed in class I carious lesion in primary molars, the procedure done for control group is bulk - fill composite placed in class I carious lesion in primary molars. The inclusion criteria include healthy children of age group 5-9 years with a behavior rating scale of 3 and 4 according to Frankl with class I carious lesion, and caries of ICDAS score of 4 and 5. Exclusion criteria include uncooperative children with systemic disease, developmental defects, teeth with discoloration pathological mobility and teeth with pulpal exposure or indicated for extraction. The clinical evaluation of the materials is done by 3, 6, 12 months recall using FDI criteria i.e. functional, biological, esthetic properties.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 42

Inclusion Criteria

Healthy children Behavior rating of 3 or 4 according to the Frankl scale Both male and female, aged between 5-9yrs Caries lesions of class I The caries had to be an ICDAS score of 4 & 5.

Exclusion Criteria

Presence of systemic diseases.
Uncooperative children Teeth with discoloration Developmental defects Pathological mobility.
Pulp exposure or indication for endodontic treatment or extraction.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
clinical performance i.e., functional esthetic and biological properties of the restorative materials using FDI criteria	3months \| 6months \| 12 months

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Sri Venkateshwaraa Dental College
🇮🇳
Pondicherry, PONDICHERRY, India
Sri Venkateshwaraa Dental College
🇮🇳Pondicherry, PONDICHERRY, India
Dr Mary Verghese
Principal investigator
9840176057
mjnmary174@gmail.com