An interventional study of Hall technique and Conventional technique in Child, Only and Quality of Life, sponsored by Izmir Katip Celebi University. Completed at 1 site in Turkey. Open to participants aged 5 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Treatment
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.
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.
Izmir Katip Celebi University is the lead sponsor of 191 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
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
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
Prepless crown technique
1 or 1,5 mm preparation on mesial, distal and occlusal of the tooth
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Immediately before the procedure and one month control
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
Time frame: 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
Time frame: Immediately after the procedure and one month control
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Izmir Katip Celebi University