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

Quality of Life Clinical Trial

Official title:

Evaluation of The Effect of Crowns Applied wıth Hall Technique on Occlusion: Randomized Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06220383
• Other study ID #: 2022-TDU-DISF-0013
• Status: Completed
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: December 20, 2023

Study information

• Verified date: January 2024
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 20, 2023
• Est. primary completion date: October 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Child, Only
• Quality of Life

Intervention

Procedure:
• Hall technique
Prepless crown technique
• Conventional technique
1 or 1,5 mm preparation on mesial, distal and occlusal of the tooth

Locations

Country	Name	City	State
Turkey	Funda Çagirir Dindaroglu	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The measurement of intrusion of teeth with stainless steel crown applied with Hall technique using Gom Inspect	Intrusion scores in Hall technique 0-3, where 0 means no movement, 3 means intrusion	Immediately before the procedure and one month control
Primary	The measurement of intrusion of teeth with stainless steel crown applied with conventional technique using Gom Inspect	0-3, where 0 means no movement, 3 means extrusion	Immediately before the procedure and one month control
Primary	Change from measurement the distance between the cusps of canines with stainless steel crown applied with Hall technique using Exocad	0-2, where 0 means no movement, 2 means no closure	Immediately before the procedure and one month control
Primary	Change from measurement the distance between the cusps of canines with stainless steel crown applied with conventional technique using Exocad	0-2, where 0 means no movement, 2 means no closure	Immediately before the procedure and one month control
Secondary	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	Child sections have a possible range from 0 to 36. 0=Never or hardly ever 36= Occasionally, often, or very often	Immediately after the procedure and one month control
Secondary	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	Family sections have a possible range from 0 to 16. 0=Never or hardly ever 16= Occasionally, often, or very often	Immediately after the procedure and one month control