NCT Number: NCT01858298
Conservative Versus Non-conservative Treatment for Severe Dental Caries
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.
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Notify MeKey information
Age range
3 year–5 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
- Oral Health-Related Quality of Life:
- Brazilian SOHO-5
- Brazilian ECOHIS
- Anthropometric measures:
- Weight-for-age Z-score (WAZ)
- Height-for-age Z-score (HAZ)
- BMI-for age Z-score (BAZ)
- Dental anxiety (Facial Image Scale).
- Dental pain (Wong-Baker Scale)
- Problems in the developing occlusion: loss of space
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Non-conservative treatment: Tooth extraction
OtherPrimary outcomes
-
oral health-related quality of life
Time frame: 12 months
- OHRQoL instruments: Brazilian SOHO-5 Brazilian ECOHIS
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
University of Sao Paulo
Other
Collaborators
- Federal University of Minas Gerais
- University College, London
Registry information
Official study 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
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2015
- First posted
- May 21, 2013
- Registry last updated
- May 27, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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