Clinical Trial: Conservative Versus Non-conservative Treatment for Severe Dental Caries

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Measure

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 Summary:

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 Hea
    Sponsor: University of Sao Paulo

    Current Primary Outcome: oral health-related quality of life [ Time Frame: 12 months ]

    - OHRQoL instruments: Brazilian SOHO-5 Brazilian ECOHIS


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • anthropometric measures [ Time Frame: 12 months ]
      • 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 ]
      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 ]
      Scale anxiety using the Facial Image Scale
    • Dental pain [ Time Frame: 12 months ]
      The Wong-Baker Faces Pain Scale will be used to asses dental pain


    Original Secondary Outcome:

    • anthropometric measures [ Time Frame: 12 months ]
      • 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 ]
      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 ]
      Scale anxiety using the Facial Image Scale


    Information By: University of Sao Paulo

    Dates:
    Date Received: May 9, 2013
    Date Started: December 2013
    Date Completion:
    Last Updated: May 26, 2015
    Last Verified: May 2015