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

NCT06220383 | Completed DMC

• 1 other identifier: 2022-TDU-DİŞF-0013
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Child, Only; Quality of Life

Keywords

Hall technique; Paediatric dentistry; Stainless Steel

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Hall technique

EXPERIMENTAL

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.

Procedure: Hall technique

Conventional technique

ACTIVE COMPARATOR

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).

Procedure: Conventional technique

Interventions

Hall technique PROCEDURE

Prepless crown technique

Hall technique

Conventional technique PROCEDURE

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

Conventional technique

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Funda Çağırır Dindaroğlu

Izmir, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization was performed by a computer-generated random sorting sequence
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled, double-blind clinical trial

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 23, 2024
• Study Start: October 5, 2022
• Primary Completion: October 12, 2023
• Study Completion: December 20, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

TU (1)