Dental CariesNCT01858298
Conservative Versus Non-conservative Treatment for Severe Dental Caries
A study testing Conservative treatment: pulpectomy and composite resin crown and Non-conservative treatment: Tooth extraction in people with Dental Caries, run by University of Sao Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Conservative treatment: pulpectomy and composite resin crown and Non-conservative treatment: Tooth extraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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
- Conditions
- Dental Caries
- Being tested
- Conservative treatment: pulpectomy and composite resin crown, Non-conservative treatment: Tooth extraction
- Keywords
- Dental caries, Quality of Life, Pulpectomy, Tooth extraction
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatment: pulpectomy and composite resin crownOther
Non-conservative treatment: Tooth extractionOther
| Study group | Role | What they receive |
|---|---|---|
| pulpectomy | Experimental | The technique of pulpectomy will be performed in one appointment according to clinical guidelines and followed by a composite resin crown. Receives: Other: Conservative treatment: pulpectomy and composite resin crown |
| tooth extraction | Experimental | The technique of tooth extraction of primary teeth will be performed according to clinical guidelines Receives: Other: Non-conservative treatment: Tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral health-related quality of life
- OHRQoL instruments: Brazilian SOHO-5 Brazilian ECOHIS
Measured: 12 months
Secondary outcomes (4)
anthropometric measures
- Weight-for-age Z-score (WAZ)
- Height-for-age Z-score (HAZ)
- BMI-for age Z-score (BAZ)
Measured: 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
Measured: 12 months
dental anxiety
Scale anxiety using the Facial Image Scale
Measured: 12 months
Dental pain
The Wong-Baker Faces Pain Scale will be used to asses dental pain
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London, Federal University of Minas Gerais
- Responsible party
- Principal investigator, Jenny Abanto, University of Sao Paulo
- Investigators
- Jenny Abanto, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858298
- Sponsor's protocol ID
- usp
- Other IDs
- 2013/10330-8
- Status last verified
- May 2015
- First submitted
- 9 May 2013
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01858298
- Acronym / sponsor ID
- usp
- Conditions
- Dental Caries
- Keywords
- Dental caries, Quality of Life, Pulpectomy, Tooth extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- University College, London, Federal University of Minas Gerais
- Study start
- Dec 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulpectomy | Experimental | Other: Conservative treatment: pulpectomy and composite resin crownThe technique of pulpectomy will be performed in one appointment according to clinical guidelines and followed by a composite resin crown. |
| tooth extraction | Experimental | Other: Non-conservative treatment: Tooth extractionThe technique of tooth extraction of primary teeth will be performed according to clinical guidelines |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative treatment: pulpectomy and composite resin crown | Other | pulpectomy |
| Non-conservative treatment: Tooth extraction | Other | tooth extraction |
Primary outcome
oral health-related quality of life
Time frame: 12 months
- OHRQoL instruments: Brazilian SOHO-5 Brazilian ECOHIS
4 secondary outcomes
anthropometric measures
Time frame: 12 months
loss of space
Time frame: 12 months
dental anxiety
Time frame: 12 months
Dental pain
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Abanto, PhD principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Conservative treatment: pulpectomy and composite resin crown and Non-conservative treatment: Tooth extraction in people with Dental Caries, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral health-related quality of life (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.