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

Sponsor

Hacettepe University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03433157

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Primary Teeth Dental Caries Dentin, Carious	Device: Hall technique Device: Traditional technique	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe University	Ankara		Turkey	06100

Sponsors and Collaborators

Hacettepe University

Investigators

Principal Investigator: Zafer C Cehreli, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Zafer Cavit Cehreli, DDS, PhD, Principal Investigator, Hacettepe University

ClinicalTrials.gov Identifier:

NCT03433157

Other Study ID Numbers:

Hall vs SSC

First Posted:

Feb 14, 2018

Last Update Posted:

Mar 15, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zafer Cavit Cehreli, DDS, PhD, Principal Investigator, Hacettepe University

stainless stain crowns

Hall technique

children

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Mar 15, 2021