Conservative Versus Non-conservative Treatment for Severe Dental Caries
2 other identifiers
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMay 27, 2015
May 1, 2015
3 months
May 9, 2013
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
oral health-related quality of life
\- OHRQoL instruments: Brazilian SOHO-5 Brazilian ECOHIS
12 months
Secondary Outcomes (4)
anthropometric measures
12 months
loss of space
12 months
dental anxiety
12 months
Dental pain
12 months
Study Arms (2)
pulpectomy
EXPERIMENTALThe technique of pulpectomy will be performed in one appointment according to clinical guidelines and followed by a composite resin crown.
tooth extraction
EXPERIMENTALThe technique of tooth extraction of primary teeth will be performed according to clinical guidelines
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sao Paulolead
- University College, Londoncollaborator
- Federal University of Minas Geraiscollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jenny Abanto, PhD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Post-doctoral student
Study Record Dates
First Submitted
May 9, 2013
First Posted
May 21, 2013
Study Start
December 1, 2013
Primary Completion
March 1, 2014
Study Completion
March 1, 2015
Last Updated
May 27, 2015
Record last verified: 2015-05