NCT03640013

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

3.2 years

First QC Date

August 12, 2018

Last Update Submit

August 20, 2018

Conditions

Caries, Dental

Outcome Measures

Primary Outcomes (1)

  • Survival

    If PMC intact and crown functional or not

    24 months

Secondary Outcomes (4)

  • Gingival helath

    24 months

  • Plaque Index

    24 months

  • Occlusion

    24 months

  • Anxiety

    12 months

Study Arms (2)

Hall Technique

EXPERIMENTAL

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.

Procedure: Hall Technique PMC

Conventional Technique

OTHER

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.

Procedure: Hall Technique PMC

Interventions

Hall Technique PMCPROCEDURE

Hall Technique primary fitted crowns to restore carious primary molars

Conventional TechniqueHall Technique

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children with Class I or class II carious primary molars

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 26718872BACKGROUND

  • 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.

    PMID: 5237684BACKGROUND

  • 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.

    PMID: 11853248BACKGROUND

  • 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.

    PMID: 31158253DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Dr Yousra, PhD

    University of Khartoum

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Controlled randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2018

First Posted

August 21, 2018

Study Start

February 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

August 22, 2018

Record last verified: 2018-08