Conservative Versus Non-conservative Treatment for Severe Dental Caries
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conservative treatment: pulpectomy and composite resin crown
Non-conservative treatment: Tooth extraction
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring Dental caries, Quality of Life, Pulpectomy, Tooth extraction
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
pulpectomy
tooth extraction
Arm Description
The technique of pulpectomy will be performed in one appointment according to clinical guidelines and followed by a composite resin crown.
The technique of tooth extraction of primary teeth will be performed according to clinical guidelines
Outcomes
Primary Outcome Measures
oral health-related quality of life
- OHRQoL instruments: Brazilian SOHO-5 Brazilian ECOHIS
Secondary Outcome Measures
anthropometric measures
Weight-for-age Z-score (WAZ)
Height-for-age Z-score (HAZ)
BMI-for age Z-score (BAZ)
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
dental anxiety
Scale anxiety using the Facial Image Scale
Dental pain
The Wong-Baker Faces Pain Scale will be used to asses dental pain
Full Information
NCT ID
NCT01858298
First Posted
May 9, 2013
Last Updated
May 26, 2015
Sponsor
University of Sao Paulo
Collaborators
University College, London, Federal University of Minas Gerais
1. Study Identification
Unique Protocol Identification Number
NCT01858298
Brief Title
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
University College, London, Federal University of Minas Gerais
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Dental caries, Quality of Life, Pulpectomy, Tooth extraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pulpectomy
Arm Type
Experimental
Arm Description
The technique of pulpectomy will be performed in one appointment according to clinical guidelines and followed by a composite resin crown.
Arm Title
tooth extraction
Arm Type
Experimental
Arm Description
The technique of tooth extraction of primary teeth will be performed according to clinical guidelines
Intervention Type
Other
Intervention Name(s)
Conservative treatment: pulpectomy and composite resin crown
Intervention Type
Other
Intervention Name(s)
Non-conservative treatment: Tooth extraction
Primary Outcome Measure Information:
Title
oral health-related quality of life
Description
- OHRQoL instruments: Brazilian SOHO-5 Brazilian ECOHIS
Time Frame
12 months
Secondary Outcome Measure Information:
Title
anthropometric measures
Description
Weight-for-age Z-score (WAZ)
Height-for-age Z-score (HAZ)
BMI-for age Z-score (BAZ)
Time Frame
12 months
Title
loss of space
Description
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
Title
dental anxiety
Description
Scale anxiety using the Facial Image Scale
Time Frame
12 months
Title
Dental pain
Description
The Wong-Baker Faces Pain Scale will be used to asses dental pain
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenny Abanto, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Conservative Versus Non-conservative Treatment for Severe Dental Caries
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