Evaluation of the attachment of caries associated bacteria to two different types of crowns in children

Not yet recruiting

Conditions: Dental Caries

Registration Number: CTRI/2020/07/026487

Lead Sponsor: Self

Brief Summary: Purpose and Aim

Plaque accumulation on the surface of dental restorations leads to the development of secondary caries or new caries or gingival and periodontal inflammation. Hence, there is a need to assess which restorations favours or disfavour accumulation of plaque. Therefore, the aim of the present study is to evaluate and compare the adhesion of S Mutans and S Sobrinus to the preformed stainless-steel crowns and zirconia crowns in children aged 5-9 years

Methodology

the present study will be a single centered, two arm, explanatory, equivalence randomized clinical trial with split mouth study design and balanced allocation ratio of 1:1. 35 Children (35 teeth for stainless steel crowns and 35 teeth for zirconia crowns) who requires endodontic treatment of two carious primary molars and who met all the inclusion criteria will be included. The participants will be allotted to either of the two groups based on block randomization. A centralized assignment will be used as an allocation concealment mechanism to prevent selection bias. After that, endodontic treatment will be performed under local anaesthesia and the tooth is restored either with preformed stainless-steel crowns or zirconia crowns. Plaque samples will be collected from the buccal cervical surface of the crowns at 1 month, 3 months and 6 months of follow up and sent for bacterial analysis through PCR.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

Children and parents willing to participate in the study Children aged 6 to 9 years with two carious primary molars which requires endodontic therapy contralaterally The primary tooth should be having at least two third of the roots Children with Frankâ€™s behaviour rating 3 & 4.

Exclusion Criteria

Children with systematic health problems, periodontal disease, a unilateral chewing habit, or allergies to local anesthetics and/or nickel were excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the adhesion of Streptococcus Mutans and Sobrinus to preformed zirconia and stainless steel crowns	1 week \| 1 month \| 3 months \| 6 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the adhesion of different serotypes of Streptococcus Mutans to preformed zirconia and staineless steel crowns	1 week

Trial Locations

Locations (1): AMEs Dental College and Hospital
🇮🇳
Raichur, KARNATAKA, India
AMEs Dental College and Hospital
🇮🇳Raichur, KARNATAKA, India
Dr T Namratha
Principal investigator
9704058513
namratha.tharay@yahoo.com