Assessment of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique

Not Applicable

• Conditions: Dental Caries; Primary Teeth; Dentin, Carious
• Interventions: Device: Hall technique; Device: Traditional technique

• Registration Number: NCT03433157
• Lead Sponsor: Hacettepe University

Brief Summary

The purpose of this study is to evaluate and compare the clinical performance of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique

Detailed Description

Stainless Stain Crowns (SSCs) will be placed on two primary molar teeth with proximal caries, in a split mouth design. 200 patients will be included in the study. The teeth will be randomized into two groups according to the technique.

Group 1: SSCs that will be placed using Traditional Technique Group 2: SSCs that will be placed using Hall Technique The cooperation of the child during the procedure will be assessed with Frankl scale. The crowns will be evaluated at baseline and 1., 6., 12., 18., 24. months. Radiographical evaluations will be at 6.,12. and 24. months. The data will be analysed statistically using chi square test and Log-Rank test and the Kaplan-Meier survival method will be used to estimate survival percentages.

Study Timeline

• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-14
• Study Start: 2019-08-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-12
• Last Update Posted: 2021-03-15
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients and parents of the patients who accept to participate and sign the informed consent
• Patients who have two first and/or second primary molars with caries affecting at least two surfaces
• Patients who are cooperative for the dental procedure

Exclusion Criteria

• Patients and parents of the patients who does not accept to participate and sign the informed consent
• Teeth that are previously restored
• Patients with a systemic disease,
• Patients who have orthodontic treatment
• Teeth which have a short period of time for succedaneous teeth to erupt
• Teeth which need vital or non-vital endodontic treatment
• Patients and/or parents who does not accept the esthetic appearance of SSC

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hall technique	Hall technique	SSCs placed on primary teeth using Hall technique
Traditional technique	Traditional technique	SSCs placed on primary teeth using Traditional technique

Primary Outcome Measures

Name	Time	Method
Clinical performance of Stainless Stain Crowns (SSCs) Placed Using the Hall Technique and Traditional Technique	2 years	Assessment of SSCs placed with two different techniques on primary molar teeth. The cooperation of children will be assessed with Frankl Scale (1:definitely negative, 2:negative, 3:positive, 4:definitely positive).; Evaluation criteria will be; * spontaneous pain (absent/present); * tenderness to percussion/palpation (absent/present); * mobility (no mobility/ 1mm/ 2mm/ 3mm mobility); * swelling (absent/present); * fistula (absent/present); * periapical/interradicular radiolucency (absent/present); * widened periodontal ligament (absent/present); * loss of lamina dura (absent/present); * internal/external root resorption (absent/present); * the marginal adaptation of each crown: good when the margins were sealed / poor when the margins were open; * retention of the crown (absent/ present); * fracture of the crown (absent/ present); * gingival health/gingivitis (absent/ present); * plaque around the crown (absent/ present)

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey