Comparing Hall vs Conventional Technique in Placing Preformed Metal Crowns From Sudan
- Conditions
- Caries, Dental
- Interventions
- Procedure: Hall Technique PMC
- Registration Number
- NCT03640013
- Lead Sponsor
- Khartoum Centre for Research and Medical Training
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
- Healthy children with Class I or class II carious primary molars
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hall Technique Hall Technique PMC The intervention involves removal from the primary molar and a preformed metal crown is placed using glass ionomer. The subject is then asked to bite until crown is seated. No occlusal adjustment is carried out. Conventional Technique Hall Technique PMC The procedure involves administering local anesthetic and the intervention involves remoal of caries from the affected primary molar. The tooth is then reshaped and contoured to to enable a preformed metal crown placement. Occlusal and marginal fit is improved by crimping the metal crown to improve fit. The preformed metal crown is cemented with glass ionomer restorative material and occlusion finally checked. The subject is then asked to bite on a cotton roll for two minutes until the cement has set.
- Primary Outcome Measures
Name Time Method Survival 24 months If PMC intact and crown functional or not
- Secondary Outcome Measures
Name Time Method Gingival helath 24 months Modified gingival index after Löe et al. (1967); Scale; 0=No disease; 1=hyperplasia with no bleeding; 2= hyperplasia with bleeding
Plaque Index 24 months Plaque accumulation around preformed metal crown after Loe et al (1967); Scale: 0= no plaque, 1= subgingival plaque; 2= supragingival plaque
Occlusion 24 months Natural teeth are in occlusion following PMC placement
Anxiety 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