Evaluation of the Occlusal Effects of the Hall Technique and Investigation of Children's Satisfaction

NCT06012409 | Completed

• 1 other identifier: DHF-21008
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The Hall Technique (HT) is a non-invasive, easily applicable minimally invasive dentistry approach for managing dental caries in children. It involves placing a preformed metal crown over a tooth with decay, to seal it in and stop the decay from progressing. However, it alters the occlusion as no tooth substance is removed to make space for the crown. Objective: This study, aims to evaluate the effects of Hall Technique on occlusion in children, to assess whether there are any adverse effects on the temporomandibular joint and masseter muscles, related to changes on occlusion and to evaluate the children's perceptions of the crowns. Materials and Methods: A total of 37 children aged 5-9 years, who have not been treated with the Hall Technique previously and who have dentinal caries that did not reach the pulp (affecting the occlusal or the occluso-proximal surfaces) in their primary molars, will be invited to participate in the study. At the first visit, clinical examination will be carried out and intraoral impressions will be taken for pre-treatment evaluation. The occlusal vertical dimension of the teeth will be measured clinically with callipers. Temporomandibular joint and masseter muscles will be examined clinically. Then, the Hall Technique crown will be placed to treat the carious tooth, the impressions taken again, and measurements repeated. At one and three months following treatment with the crown, the participant will have the measurements repeated. The child and parent will complete a questionnaire after 3 months on their perception of the crown. In the data analysis, frequency, percentage, mean and standard deviation analyses will be used for demographic data and description of the clinical data. In numerical data analysis, t-test or Mann-Whitney U test will be used according to the data distribution. Geomagic software will be used to analyse sequential study models of the teeth to measure relative changes in the tooth positions over time.

Conditions

Dental Caries in Children

Keywords

Dental Caries; Children; Occlusion

Outcome Measures

Primary Outcomes (4)

• Digital Occlusal Analysis

  3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).

  Baseline

• Digital Occlusal Analysis

  3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).

  Immediately After Treatment

• Digital Occlusal Analysis

  3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).

  1 Month

• Digital Occlusal Analysis

  3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).

  3 Month

Secondary Outcomes (14)

• Occlusal Vertical Dimension (OVD) Measurements

  Baseline

• Occlusal Vertical Dimension (OVD) Measurements

  Immediately After Treatment

• Occlusal Vertical Dimension (OVD) Measurements

  1 month

• Occlusal Vertical Dimension (OVD) Measurements

  3 month

• Detect any negative effects on the TMJ

  Baseline

Interventions

Hall Technique Prefabricated Metal Crown DEVICE

The Hall Technique is a type of minimally invasive dental treatment. Hall Technique involves sealing the carious lesion under a Prefabricated Metal Crown to stop its progression preventing pain and/or infection.This makes the technique less invasive and it can be more acceptable to children than a traditional filling involving injections and drilling.

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be selected and recruited from children attending for routine dental care at Aydin Adnan Menderes University Paediatric Dentistry Clinic. Children and their parents will be invited to participate and will be included in the study after they have the study discussed with them and they agree to participate, giving informed consent. Children should meet the inclusion criteria, and/or be none of the exclusion criteria

Children are eligible for inclusion if: * they are 5 to 9 years old; * they fit the clinical criteria to receive a HTPMC to manage primary molars carious lesions; * they have antagonist primary molar * they have not had a HTPMC fitted before; * their parents can understand what is involved in the study and have signed and given assent to participate; * they can cooperate with dental care including having a dental impression taken; and * their parents are willing and able to bring them to the follow-up appointments 4, and 12 weeks after the treatment. Children will be excluded from the study if: * They do not have a parental agreement to participate; or * They have self-reported occlusal parafunctional habits (e.g. bruxism, constantly open mouths).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead
• Cardiff University: collaborator

Study Sites (1)

Melis AKYILDIZ

Efeler, Aydın, 09100, Turkey (Türkiye)

Location

Related Publications (8)

• Uribe SE, Innes N, Maldupa I. The global prevalence of early childhood caries: A systematic review with meta-analysis using the WHO diagnostic criteria. Int J Paediatr Dent. 2021 Nov;31(6):817-830. doi: 10.1111/ipd.12783. Epub 2021 Apr 30.

  PMID: 33735529 BACKGROUND

• Klingberg G, Broberg AG. Dental fear/anxiety and dental behaviour management problems in children and adolescents: a review of prevalence and concomitant psychological factors. Int J Paediatr Dent. 2007 Nov;17(6):391-406. doi: 10.1111/j.1365-263X.2007.00872.x.

  PMID: 17935593 BACKGROUND

• Innes NP, Evans DJ, Stirrups DR. The Hall Technique; a randomized controlled clinical trial of a novel method of managing carious primary molars in general dental practice: acceptability of the technique and outcomes at 23 months. BMC Oral Health. 2007 Dec 20;7:18. doi: 10.1186/1472-6831-7-18.

  PMID: 18096042 BACKGROUND

• van der Zee V, van Amerongen WE. Short communication: Influence of preformed metal crowns (Hall technique) on the occlusal vertical dimension in the primary dentition. Eur Arch Paediatr Dent. 2010 Oct;11(5):225-7. doi: 10.1007/BF03262751.

  PMID: 20932395 BACKGROUND

• Abu Serdaneh S, AlHalabi M, Kowash M, Macefield V, Khamis AH, Salami A, Hussein I. Hall technique crowns and children's masseter muscle activity: A surface electromyography pilot study. Int J Paediatr Dent. 2020 May;30(3):303-313. doi: 10.1111/ipd.12611. Epub 2020 Jan 24.

  PMID: 31894621 BACKGROUND

• Shih YC, Yang R, Zou J. Assessment of occlusion and temporomandibular joint after placing preformed metal crowns on all primary molars in children. Int J Paediatr Dent. 2022 Nov;32(6):915-924. doi: 10.1111/ipd.12970. Epub 2022 May 18.

  PMID: 35484864 BACKGROUND

• Elamin F, Abdelazeem N, Salah I, Mirghani Y, Wong F. A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan. PLoS One. 2019 Jun 3;14(6):e0217740. doi: 10.1371/journal.pone.0217740. eCollection 2019.

  PMID: 31158253 BACKGROUND

• Hesse D, de Araujo MP, Olegario IC, Innes N, Raggio DP, Bonifacio CC. Atraumatic Restorative Treatment compared to the Hall Technique for occluso-proximal cavities in primary molars: study protocol for a randomized controlled trial. Trials. 2016 Mar 31;17:169. doi: 10.1186/s13063-016-1270-z.

  PMID: 27029801 BACKGROUND

MeSH Terms

Conditions

Dental Caries; Bites and Stings

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Nicola INNES, PhD

  Cardiff University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 25, 2023
• Study Start: February 18, 2023
• Primary Completion: September 1, 2023
• Study Completion: January 1, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

TU (1)