Caries, Dental Clinical Trial
Official title:
A Randomized Clinical Trial Comparing Hall vs Conventional Technique in Placing Preformed Metal Crowns From Sudan
Verified date | August 2018 |
Source | Khartoum Centre for Research and Medical Training |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Khartoum Centre for Research and Medical Training |
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
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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