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Completed

NCT Number: NCT06220383

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

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.

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Key information

Conditions

Child, Only Quality of Life

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Funda Çağırır Dindaroğlu

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hall technique

Procedure

Prepless crown technique

Conventional technique

Procedure

1 or 1,5 mm preparation on mesial, distal and occlusal of the tooth

Primary outcomes

  1. The measurement of intrusion of teeth with stainless steel crown applied with Hall technique using Gom Inspect

    Time frame: Immediately before the procedure and one month control

    Intrusion scores in Hall technique 0-3, where 0 means no movement, 3 means intrusion

  2. The measurement of intrusion of teeth with stainless steel crown applied with conventional technique using Gom Inspect

    Time frame: Immediately before the procedure and one month control

    0-3, where 0 means no movement, 3 means extrusion

  3. Change from measurement the distance between the cusps of canines with stainless steel crown applied with Hall technique using Exocad

    Time frame: Immediately before the procedure and one month control

    0-2, where 0 means no movement, 2 means no closure

  4. Change from measurement the distance between the cusps of canines with stainless steel crown applied with conventional technique using Exocad

    Time frame: Immediately before the procedure and one month control

    0-2, where 0 means no movement, 2 means no closure

Secondary outcomes

  1. 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

    Time frame: 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

  2. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2024
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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