Evaluation of The Effect of Crowns Applied With Hall Technique on Occlusion

Not Applicable

Completed

• Conditions: Quality of Life; Child, Only
• Interventions: Procedure: Hall technique; Procedure: Conventional technique

• Registration Number: NCT06220383
• Lead Sponsor: Izmir Katip Celebi University

Brief Summary

This study aims to evaluate and compare the change on occlusion after placing stainless steel crowns (SCC) using Hall technique and conventional technique in children between the ages of 5-8. In addition, the investigators planned to analyze the change in oral health-related quality of life between SCC applied with the Hall technique and SCC applied with the conventional method, before and after clinical application.

Detailed Description

First, the participants who met the inclusion criteria were included in 2 study groups according to age, gender, dental experience, tooth number, applied stainless steel crown technique, Decayed, Missing due to caries, and Filled teeth in the permanent teeth/decayed, missing due to caries, and filled teeth in the deciduous teeth (DMFT/dmft index) values and International Caries Detection and Assessment System (ICDAS II) and radiographic evaluation criteria. In the experimental group, stainless steel crowns were placed on the teeth of 39 participants using the Hall technique. In the control group, stainless steel crowns were placed on the teeth of 39 participants using conventional technique.

Study Timeline

• Study Start: 2022-10-05
• Primary Completion: 2023-10-12
• Study Completion: 2023-12-20
• Status Verified: 2024-01
• Study First Submitted: 2024-01-14
• Study First Submitted QC: 2024-01-14
• Study First Posted: 2024-01-23
• Last Update Submitted: 2024-01-28
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Subjects with American Society of Anesthesiologists score I (ASA I),
• Subjects with Frankl's behavior rate III (positive) and IV (definitely positive),
• Clinically, Black class II enamel-dentin caries in the upper jaw primary second molar is; ICDAS II Scale score 4, score 5 and the accepted values in the evaluation of radiographic dental caries are D1-RA3, D2-RB4, D3-RC5,
• Antagonist of the tooth planned to be processed,
• Lamina dura and periodontal space can be observed normally
• There is permanent tooth germ underneath or the position is normal.

Exclusion Criteria

• Allergic to the local anesthetics or sulfites,
• Had teeth with pain or sepsis,
• Were uncooperative during clinical examination,
• TMJ disorder,
• Had parafunctional habit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hall technique	Hall technique	In the Hall technique method, an orthodontic separator was placed 2 days before the procedure to create distance for the crown in the mesial and distal contact areas of the tooth on which the crown will be placed. A stainless steel crown was cemented on the tooth with glass ionomer cement without local anesthesia, caries cleaning or any preparation. The participant was asked to close the teeth tightly for 2-3 minutes.
Conventional technique	Conventional technique	In the conventional technique, after the area to be anesthetized was dried, topical anesthetic solution (Locanest 10% spray lidocaine, Avixa, Turkey) was applied to the mucosa with a cotton pellet for one minute. For infiltrative anesthesia, 4% articaine solution (Ultracaine DS Forte ampoule, Sanofi-Aventis GmbH, Germany) containing 1 ml of 1:100,000 epinephrine was applied. Preparation was made on the mesial, distal and occlusal sides of the tooth. The decay was cleaned and the cavity was filled with glass ionomer cement (Ketac Molar Easymix, 3M™ ESPE™, St. Paul, MN, USA). The stainless steel crown was bonded with glass ionomer cement (Ketac Cem Easymix, 3M™ ESPE™, St. Paul, MN, USA).

Primary Outcome Measures

Name	Time	Method
The measurement of intrusion of teeth with stainless steel crown applied with Hall technique using Gom Inspect	Immediately before the procedure and one month control	Intrusion scores in Hall technique 0-3, where 0 means no movement, 3 means intrusion
The measurement of intrusion of teeth with stainless steel crown applied with conventional technique using Gom Inspect	Immediately before the procedure and one month control	0-3, where 0 means no movement, 3 means extrusion
Change from measurement the distance between the cusps of canines with stainless steel crown applied with conventional technique using Exocad	Immediately before the procedure and one month control	0-2, where 0 means no movement, 2 means no closure
Change from measurement the distance between the cusps of canines with stainless steel crown applied with Hall technique using Exocad	Immediately before the procedure and one month control	0-2, where 0 means no movement, 2 means no closure

Secondary Outcome Measures

Name	Time	Method
Measuring the impact of stainless steel crowns on oral health and quality of life in children section with the Early Childhood Oral Health Impact Scale	Immediately after the procedure and one month control	Child sections have a possible range from 0 to 36. 0=Never or hardly ever 36= Occasionally, often, or very often
Measuring the impact of stainless steel crowns on oral health and quality of life in parents section with the Early Childhood Oral Health Impact Scale	Immediately after the procedure and one month control	Family sections have a possible range from 0 to 16. 0=Never or hardly ever 16= Occasionally, often, or very often

Trial Locations

Locations (1)

Funda Çağırır Dindaroğlu; 🇹🇷 İzmir, Turkey