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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
oral health-related quality of life
\- OHRQoL instruments: Brazilian SOHO-5 Brazilian ECOHIS
Time frame: 12 months
anthropometric measures
* Weight-for-age Z-score (WAZ) * Height-for-age Z-score (HAZ) * BMI-for age Z-score (BAZ)
Time frame: 12 months
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
Time frame: 12 months
dental anxiety
Scale anxiety using the Facial Image Scale
Time frame: 12 months
Dental pain
The Wong-Baker Faces Pain Scale will be used to asses dental pain
Time frame: 12 months
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