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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03433157
• Other study ID #: Hall vs SSC
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 2024

Study information

• Verified date: March 2021
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dentin, Carious
• Primary Teeth

Intervention

Device:
• Hall technique
Metal Stainless stain crown placed with Hall technique
• Traditional technique
Metal Stainless stain crown placed with Traditional technique

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Innes NP, Stewart M. The Hall Technique, a Simplified Method for Placing Stainless Steel Crowns on Primary Molars, may be as Successful as Traditionally Placed Crowns. J Evid Based Dent Pract. 2015 Jun;15(2):70-2. doi: 10.1016/j.jebdp.2015.03.008. Epub 2015 Mar 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 years