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

Caries, Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03640013
• Other study ID #: KhartoumCentre
• Status: Completed
• Phase: N/A
• Start date: February 1, 2015
• Est. completion date: May 1, 2018

Study information

• Verified date: August 2018
• Source: Khartoum Centre for Research and Medical Training
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries, Dental
• Dental Caries

Intervention

Procedure:
• Hall Technique PMC
Hall Technique primary fitted crowns to restore carious primary molars

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Khartoum Centre for Research and Medical Training

References & Publications (3)

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. — View 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;(12):CD005512. doi: 10.1002/14651858.CD005512.pub3. Review. — View Citation

Löe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	If PMC intact and crown functional or not	24 months
Secondary	Gingival helath	Modified gingival index after Löe et al. (1967); Scale; 0=No disease; 1=hyperplasia with no bleeding; 2= hyperplasia with bleeding	24 months
Secondary	Plaque Index	Plaque accumulation around preformed metal crown after Loe et al (1967); Scale: 0= no plaque, 1= subgingival plaque; 2= supragingival plaque	24 months
Secondary	Occlusion	Natural teeth are in occlusion following PMC placement	24 months
Secondary	Anxiety	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	12 months