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

Primary Purpose

Caries, Dental

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hall Technique PMC
Sponsored by
Khartoum Centre for Research and Medical Training
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries, Dental

Eligibility Criteria

5 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Hall Technique

    Conventional Technique

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Survival
    If PMC intact and crown functional or not

    Secondary Outcome Measures

    Gingival helath
    Modified gingival index after Löe et al. (1967); Scale; 0=No disease; 1=hyperplasia with no bleeding; 2= hyperplasia with bleeding
    Plaque Index
    Plaque accumulation around preformed metal crown after Loe et al (1967); Scale: 0= no plaque, 1= subgingival plaque; 2= supragingival plaque
    Occlusion
    Natural teeth are in occlusion following PMC placement
    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

    Full Information

    First Posted
    August 12, 2018
    Last Updated
    August 20, 2018
    Sponsor
    Khartoum Centre for Research and Medical Training
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03640013
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2015 (Actual)
    Primary Completion Date
    May 1, 2018 (Actual)
    Study Completion Date
    May 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Khartoum Centre for Research and Medical Training

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caries, Dental

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Controlled randomized clinical trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    103 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hall Technique
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Conventional Technique
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Hall Technique PMC
    Intervention Description
    Hall Technique primary fitted crowns to restore carious primary molars
    Primary Outcome Measure Information:
    Title
    Survival
    Description
    If PMC intact and crown functional or not
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Gingival helath
    Description
    Modified gingival index after Löe et al. (1967); Scale; 0=No disease; 1=hyperplasia with no bleeding; 2= hyperplasia with bleeding
    Time Frame
    24 months
    Title
    Plaque Index
    Description
    Plaque accumulation around preformed metal crown after Loe et al (1967); Scale: 0= no plaque, 1= subgingival plaque; 2= supragingival plaque
    Time Frame
    24 months
    Title
    Occlusion
    Description
    Natural teeth are in occlusion following PMC placement
    Time Frame
    24 months
    Title
    Anxiety
    Description
    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
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr Yousra, PhD
    Organizational Affiliation
    University of Khartoum
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26718872
    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.
    Results Reference
    background
    PubMed Identifier
    5237684
    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.
    Results Reference
    background
    PubMed Identifier
    11853248
    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.
    Results Reference
    background
    PubMed Identifier
    31158253
    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.
    Results Reference
    derived

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

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