Conservative Versus Non-conservative Treatment for Severe Dental Caries

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University College, London
Federal University of Minas Gerais
Information provided by (Responsible Party):
Jenny Abanto, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01858298
First received: May 9, 2013
Last updated: January 25, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Severe Dental Caries
Other: Conservative treatment: pulpectomy and composite resin crown
Other: Non-conservative treatment: Tooth extraction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • oral health-related quality of life [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    - OHRQoL instruments: Brazilian SOHO-5 Brazilian ECOHIS


Secondary Outcome Measures:
  • anthropometric measures [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    • Weight-for-age Z-score (WAZ)
    • Height-for-age Z-score (HAZ)
    • BMI-for age Z-score (BAZ)

  • loss of space [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Scale anxiety using the Facial Image Scale

  • Dental pain [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The Wong-Baker Faces Pain Scale will be used to asses dental pain


Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pulpectomy
The technique of pulpectomy will be performed in one appointment according to clinical guidelines and followed by a composite resin crown.
Other: Conservative treatment: pulpectomy and composite resin crown
Experimental: tooth extraction
The technique of tooth extraction of primary teeth will be performed according to clinical guidelines
Other: Non-conservative treatment: Tooth extraction

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.

  1. Oral Health-Related Quality of Life:

    • Brazilian SOHO-5
    • Brazilian ECOHIS
  2. Anthropometric measures:

    • Weight-for-age Z-score (WAZ)
    • Height-for-age Z-score (HAZ)
    • BMI-for age Z-score (BAZ)
  3. Dental anxiety (Facial Image Scale).
  4. Dental pain (Wong-Baker Scale)
  5. Problems in the developing occlusion: loss of space
  Eligibility

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858298

Sponsors and Collaborators
University of Sao Paulo
University College, London
Federal University of Minas Gerais
Investigators
Principal Investigator: Jenny Abanto, PhD University of São Paulo
  More Information

No publications provided

Responsible Party: Jenny Abanto, Post-doctoral student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01858298     History of Changes
Other Study ID Numbers: usp, 2013/10330-8
Study First Received: May 9, 2013
Last Updated: January 25, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Dental caries
Quality of Life
Pulpectomy
Tooth extraction

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 01, 2014