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| ID | Type | Description | Link |
|---|---|---|---|
| 2013/10330-8 | Other Grant/Funding Number | Processo FAPESP |
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| Name | Class |
|---|---|
| University College, London | OTHER |
| Federal University of Minas Gerais | OTHER |
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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
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:
Anthropometric measures:
Dental anxiety (Facial Image Scale).
Dental pain (Wong-Baker Scale)
Problems in the developing occlusion: loss of space
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pulpectomy | Experimental | The technique of pulpectomy will be performed in one appointment according to clinical guidelines and followed by a composite resin crown. |
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| tooth extraction | Experimental | The technique of tooth extraction of primary teeth will be performed according to clinical guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conservative treatment: pulpectomy and composite resin crown | Other |
| ||
| Non-conservative treatment: Tooth extraction |
| Measure | Description | Time Frame |
|---|---|---|
| oral health-related quality of life | - OHRQoL instruments: Brazilian SOHO-5 Brazilian ECOHIS | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| anthropometric measures |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jenny Abanto, PhD | University of Sao Paulo | Principal Investigator |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Other |
|
| 12 months |
| dental anxiety | Scale anxiety using the Facial Image Scale | 12 months |
| Dental pain | The Wong-Baker Faces Pain Scale will be used to asses dental pain | 12 months |