Clinical trial NCT03640013: Comparing Hall vs Conventional Technique in Placing Preformed Metal Crowns From Sudan
Official title: A Randomized Clinical Trial Comparing Hall vs Conventional Technique in Placing Preformed Metal Crowns From Sudan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries, Dental
Lead sponsor: Khartoum Centre for Research and Medical Training
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 103
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled randomized clinical trial
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Survival
timeFrame: 24 months
Secondary outcomes:
measure: Gingival helath
timeFrame: 24 months
measure: Plaque Index
timeFrame: 24 months
measure: Occlusion
timeFrame: 24 months
measure: Anxiety
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Khartoum
name: Dr Yousra, PhD
role: STUDY_DIRECTOR
References:
citation: Innes NP, Ricketts D, Chong LY, Keightley AJ, Lamont T, Santamaria RM. Preformed crowns for decayed primary molar teeth. Cochrane Database Syst Rev. 2015 Dec 31;2015(12):CD005512. doi: 10.1002/14651858.CD005512.pub3.
citation: Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
citation: Buchanan H, Niven N. Validation of a Facial Image Scale to assess child dental anxiety. Int J Paediatr Dent. 2002 Jan;12(1):47-52.
citation: 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.