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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Dental Caries; Primary Teeth; Dentin, Carious
• Intervention / Treatment: Device: Hall technique; Device: 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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hall technique; SSCs placed on primary teeth using Hall technique	Device: Hall technique; Metal Stainless stain crown placed with Hall technique
Active Comparator: Traditional technique; SSCs placed on primary teeth using Traditional technique	Device: Traditional technique; Metal Stainless stain crown placed with Traditional technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Zafer C Cehreli, Hacettepe University

Publications and helpful links

General Publications

• 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. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 12, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: children; Hall technique; stainless stain crowns
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: Hall vs SSC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No