Clinical trial NCT01858298: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Dental caries
Quality of Life
Pulpectomy
Tooth extraction
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: University College, London
name: Federal University of Minas Gerais
First posted: 2013-05-21
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: oral health-related quality of life
timeFrame: 12 months
Secondary outcomes:
measure: anthropometric measures
timeFrame: 12 months
measure: loss of space
timeFrame: 12 months
measure: dental anxiety
timeFrame: 12 months
measure: Dental pain
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Jenny Abanto, PhD
role: PRINCIPAL_INVESTIGATOR
References: