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Conservative Versus Non-conservative Treatment for Severe Dental Caries

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conservative treatment: pulpectomy and composite resin crown
Non-conservative treatment: Tooth extraction
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Dental caries, Quality of Life, Pulpectomy, Tooth extraction

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Preschool children with severe dental caries (SDC) in primary molars.
  • SDC will be indicated by the Pufa index
  • The Pufa index records the presence of severely decayed teeth with visible pulp involvement (p), ulceration of the oral mucosa owing to root fragments (u), fistula (f) and abscess (a). Children with a pufa-score > 0 will be included in the study.

Exclusion Criteria:

  • Children with severe crowding of anterior teeth
  • Severe arch length deficiencies
  • Children with systemic and neurological diseases or those with illnesses that adversely affect growth according to parents reports
  • Children on regular nutrition supplements
  • Children who had undergone dental treatment in the last three months and who were not willing to participate in the study. Tooth with anomalies, extensive crown destruction and impossibility of absolute isolation in the conservative intervention group.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    pulpectomy

    tooth extraction

    Arm Description

    The technique of pulpectomy will be performed in one appointment according to clinical guidelines and followed by a composite resin crown.

    The technique of tooth extraction of primary teeth will be performed according to clinical guidelines

    Outcomes

    Primary Outcome Measures

    oral health-related quality of life
    - OHRQoL instruments: Brazilian SOHO-5 Brazilian ECOHIS

    Secondary Outcome Measures

    anthropometric measures
    Weight-for-age Z-score (WAZ) Height-for-age Z-score (HAZ) BMI-for age Z-score (BAZ)
    loss of space
    Extraction space The referent space was determined by measuring the distance between the mesial and distal midpoints of the adjacents teeth to extraction or pulpectomy
    dental anxiety
    Scale anxiety using the Facial Image Scale
    Dental pain
    The Wong-Baker Faces Pain Scale will be used to asses dental pain

    Full Information

    First Posted
    May 9, 2013
    Last Updated
    May 26, 2015
    Sponsor
    University of Sao Paulo
    Collaborators
    University College, London, Federal University of Minas Gerais
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01858298
    Brief Title
    Conservative Versus Non-conservative Treatment for Severe Dental Caries
    Official Title
    Conservative Versus Non-conservative Treatment for Severe Dental Caries in Preschool Children and Its Impact on Oral Health-related Quality of Life, Anthropometric Measures, Space Loss and Anxiety: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    March 2014 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    University College, London, Federal University of Minas Gerais

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the effectiveness of the conservative (pulpectomy) versus non-conservative treatment (tooth extraction) of primary molars affected with severe dental caries associated to oral health-related quality of life, anthropometric and clinical outcomes.
    Detailed Description
    Treatment: evaluate two interventions for treating severe dental caries in primary molared of preschool children. SAMPLE: preschool children aged 3 to 5 years with severe dental caries (SDC) in primary molars. SDC will be indicated by the Pufa index. The Pufa index records the presence of severely decayed teeth with visible pulp involvement (p), ulceration of the oral mucosa owing to root fragments (u), fistula (f) and abscess (a). Children with pufa-score > 0 in primary molars will be included in the study. All children aged 3 to 5 years, who sought dental screening at the Dental School, University of São Paulo (USP) in August to October 2013 can be initially eligible. CLINICAL GROUPS RANDOMLY ASSIGNED: Group A: Conservative treatment represented by pulpectomies + teeth restoration with composite resin crown. Group B: Dental extraction Treatment of carious teeth with pufa score =0 will receive dental fillings (01 occlusal surface affected: ART; 02 surfaces affected: composite resin; ≥ 03 surfaces affected: composite resin crown). One operator (specialists in paediatric dentistry) blinded to the outcomes will carry out the treatments. FOLLOW-UP: 4, 8 and 12 months. OUTCOMES: All outcomes will be assessed by a single person interviewer/examiner blinded to the oral treatments groups. Oral Health-Related Quality of Life: Brazilian SOHO-5 Brazilian ECOHIS Anthropometric measures: Weight-for-age Z-score (WAZ) Height-for-age Z-score (HAZ) BMI-for age Z-score (BAZ) Dental anxiety (Facial Image Scale). Dental pain (Wong-Baker Scale) Problems in the developing occlusion: loss of space

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries
    Keywords
    Dental caries, Quality of Life, Pulpectomy, Tooth extraction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    pulpectomy
    Arm Type
    Experimental
    Arm Description
    The technique of pulpectomy will be performed in one appointment according to clinical guidelines and followed by a composite resin crown.
    Arm Title
    tooth extraction
    Arm Type
    Experimental
    Arm Description
    The technique of tooth extraction of primary teeth will be performed according to clinical guidelines
    Intervention Type
    Other
    Intervention Name(s)
    Conservative treatment: pulpectomy and composite resin crown
    Intervention Type
    Other
    Intervention Name(s)
    Non-conservative treatment: Tooth extraction
    Primary Outcome Measure Information:
    Title
    oral health-related quality of life
    Description
    - OHRQoL instruments: Brazilian SOHO-5 Brazilian ECOHIS
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    anthropometric measures
    Description
    Weight-for-age Z-score (WAZ) Height-for-age Z-score (HAZ) BMI-for age Z-score (BAZ)
    Time Frame
    12 months
    Title
    loss of space
    Description
    Extraction space The referent space was determined by measuring the distance between the mesial and distal midpoints of the adjacents teeth to extraction or pulpectomy
    Time Frame
    12 months
    Title
    dental anxiety
    Description
    Scale anxiety using the Facial Image Scale
    Time Frame
    12 months
    Title
    Dental pain
    Description
    The Wong-Baker Faces Pain Scale will be used to asses dental pain
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Preschool children with severe dental caries (SDC) in primary molars. SDC will be indicated by the Pufa index The Pufa index records the presence of severely decayed teeth with visible pulp involvement (p), ulceration of the oral mucosa owing to root fragments (u), fistula (f) and abscess (a). Children with a pufa-score > 0 will be included in the study. Exclusion Criteria: Children with severe crowding of anterior teeth Severe arch length deficiencies Children with systemic and neurological diseases or those with illnesses that adversely affect growth according to parents reports Children on regular nutrition supplements Children who had undergone dental treatment in the last three months and who were not willing to participate in the study. Tooth with anomalies, extensive crown destruction and impossibility of absolute isolation in the conservative intervention group.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jenny Abanto, PhD
    Organizational Affiliation
    University of São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Conservative Versus Non-conservative Treatment for Severe Dental Caries

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