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

NCT ID: NCT06220383

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-05
• Study Completion Date: 2023-12-20

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.

Conditions

Child, Only; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Hall technique

Intervention Type: PROCEDURE

Prepless crown 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).

Group Type: ACTIVE_COMPARATOR

Conventional technique

Intervention Type: PROCEDURE

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

Interventions

Hall technique

Prepless crown technique

Intervention Type: PROCEDURE

Conventional technique

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

Funda Cagırır Dindaroglu

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Funda Çağırır Dindaroğlu

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022-TDU-DİŞF-0013

Identifier Type: -

Identifier Source: org_study_id