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Completed

NCT Number: NCT03640013

Comparing Hall vs Conventional Technique in Placing Preformed Metal Crowns From Sudan

Preformed metal crowns (PMCs) have high success rates in restoring primary molars in children but they were not generally used by dentists, especially in developing countries due to its demand of high clinical skills with the conventional technique (CT). The biological approach, Hall technique (HT), requires less training and can be placed by less experienced dental operators including therapists. Previous studies were mainly carried out in developed countries. The aims were to investigate and compare the efficacies and cost-effectiveness of PMCs placed by these two techniques.

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Key information

Conditions

Caries, Dental Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

A prospective randomised control trial design was used. The study was carried out in a dental practice in Sudan, an under-developed country with lower social economic group. Children between 5-8 years were invited and selected if they met the inclusion criteria. Only those who had 1-2 carious primary molars needing PMCs were randomised. The PMCs were placed by a dentist in the CT arm and by a therapist in the HT arm. The children were follow up every 6 months up to 2 years. The demographic details, periodontal health, occlusion, children anxieties, and procedure time were recorded. The Kaplan-Meier survival rates for each arm were calculated. The incremental cost effectiveness ratio (ICER) was calculated using the results and the local salaries

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy children with Class I or class II carious primary molars

Exclusion criteria

  • Had a compromised medical history
  • Were pre- or un-cooperative to have clinical examinations
  • Lived in remote villages and were unlikely to return for follow-up
  • Had teeth with pain or sepsis
  • Had teeth with caries extended in pulp either from clinical or radiographic examinations

Treatment and study plan

Hall Technique PMC

Procedure

Hall Technique primary fitted crowns to restore carious primary molars

Primary outcomes

  1. Survival

    Time frame: 24 months

    If PMC intact and crown functional or not

Secondary outcomes

  1. Gingival helath

    Time frame: 24 months

    Modified gingival index after Löe et al. (1967); Scale; 0=No disease; 1=hyperplasia with no bleeding; 2= hyperplasia with bleeding

  2. Plaque Index

    Time frame: 24 months

    Plaque accumulation around preformed metal crown after Loe et al (1967); Scale: 0= no plaque, 1= subgingival plaque; 2= supragingival plaque

  3. Occlusion

    Time frame: 24 months

    Natural teeth are in occlusion following PMC placement

  4. Anxiety

    Time frame: 12 months

    Self perceived anxiety using facial image scale after Buchanan and Niven (2002) using 5 facial diagrams ranging from sad to smiley faces: Scale; 1-5; 1=extremely happy to 5=extremely unhappy

Sponsors and collaborators

Lead sponsor

Khartoum Centre for Research and Medical Training

Other

Registry information

Official study title

A Randomized Clinical Trial Comparing Hall vs Conventional Technique in Placing Preformed Metal Crowns From Sudan

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2018
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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