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

NCT03433157 | Unknown

• 1 other identifier: Hall vs SSC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Primary Teeth; Dental Caries; Dentin, Carious

Keywords

stainless stain crowns; Hall technique; children

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Hall technique

EXPERIMENTAL

SSCs placed on primary teeth using Hall technique

Device: Hall technique

Traditional technique

ACTIVE COMPARATOR

SSCs placed on primary teeth using Traditional technique

Device: Traditional technique

Interventions

Hall technique DEVICE

Metal Stainless stain crown placed with Hall technique

Hall technique

Traditional technique DEVICE

Metal Stainless stain crown placed with Traditional technique

Traditional technique

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related 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. No abstract available.

  PMID: 25987388 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Zafer C Cehreli

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 14, 2018
• Study Start: August 1, 2019
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)