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

Hacettepe University200 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Primary Teeth Dental Caries Dentin, Carious

Interventions

Hall techniqueDEVICE

Metal Stainless stain crown placed with Hall technique

Traditional techniqueDEVICE

Metal Stainless stain crown placed with Traditional technique

Eligibility

Sex: ALLMin age: 4 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

Clinical performance of Stainless Stain Crowns (SSCs) Placed Using the Hall Technique and Traditional Technique

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)

Time frame: 2 years

Data from ClinicalTrials.gov

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