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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03640013
Other study ID # KhartoumCentre
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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