Clinical trial NCT06220383: Evaluation of The Effect of Crowns Applied With Hall Technique on Occlusion
Official title: Evaluation of The Effect of Crowns Applied wıth Hall Technique on Occlusion: Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child, Only
Quality of Life
Keywords: Hall technique
Paediatric dentistry
Stainless Steel
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 78
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled, double-blind clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The measurement of intrusion of teeth with stainless steel crown applied with Hall technique using Gom Inspect
timeFrame: Immediately before the procedure and one month control
measure: The measurement of intrusion of teeth with stainless steel crown applied with conventional technique using Gom Inspect
timeFrame: Immediately before the procedure and one month control
measure: Change from measurement the distance between the cusps of canines with stainless steel crown applied with Hall technique using Exocad
timeFrame: Immediately before the procedure and one month control
measure: Change from measurement the distance between the cusps of canines with stainless steel crown applied with conventional technique using Exocad
timeFrame: Immediately before the procedure and one month control
Secondary outcomes:
measure: 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
timeFrame: Immediately after the procedure and one month control
measure: 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
timeFrame: Immediately after the procedure and one month control
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Funda Çağırır Dindaroğlu
Study officials:
References: