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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Child, Only
• Intervention / Treatment: Procedure: Hall technique; Procedure: Conventional technique

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey
    • Funda Çağırır Dindaroğlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Procedure: Conventional technique; 1 or 1,5 mm preparation on mesial, distal and occlusal of the tooth
Experimental: 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.	Procedure: Hall technique; Prepless crown technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Actual): October 12, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: January 14, 2024
• First Submitted That Met QC Criteria: January 14, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hall technique; Paediatric dentistry; Stainless Steel
• Other Study ID Numbers: 2022-TDU-DİŞF-0013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No