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

Primary Purpose

Primary Teeth, Dental Caries, Dentin, Carious

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Hall technique

Traditional technique

About this trial

This is an interventional treatment trial for Primary Teeth focused on measuring stainless stain crowns, Hall technique, children

Eligibility Criteria

4 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hall technique

Traditional technique

Arm Description

SSCs placed on primary teeth using Hall technique

SSCs placed on primary teeth using Traditional technique

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT03433157

First Posted

February 8, 2018

Last Updated

March 12, 2021

Sponsor

Hacettepe University

1. Study Identification

Unique Protocol Identification Number

NCT03433157

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Enrolling by invitation

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Teeth, Dental Caries, Dentin, Carious

Keywords

stainless stain crowns, Hall technique, children

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hall technique

Arm Type

Experimental

Arm Description

SSCs placed on primary teeth using Hall technique

Arm Title

Traditional technique

Arm Type

Active Comparator

Arm Description

SSCs placed on primary teeth using Traditional technique

Intervention Type

Device

Intervention Name(s)

Hall technique

Intervention Description

Metal Stainless stain crown placed with Hall technique

Intervention Type

Device

Intervention Name(s)

Traditional technique

Intervention Description

Metal Stainless stain crown placed with Traditional technique

Primary Outcome Measure Information:

Title

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

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zafer C Cehreli

Organizational Affiliation

Hacettepe University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hacettepe University

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25987388

Citation

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.

Results Reference

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

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