Conservative Versus Non-conservative Treatment for Severe Dental Caries

NCT ID: NCT01858298

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-03-31

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.

1. Oral Health-Related Quality of Life:

• Brazilian SOHO-5
• Brazilian ECOHIS

2. Anthropometric measures:

• Weight-for-age Z-score (WAZ)
• Height-for-age Z-score (HAZ)
• BMI-for age Z-score (BAZ)

3. Dental anxiety (Facial Image Scale).

4. Dental pain (Wong-Baker Scale)

5. Problems in the developing occlusion: loss of space

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

pulpectomy

The technique of pulpectomy will be performed in one appointment according to clinical guidelines and followed by a composite resin crown.

Group Type: EXPERIMENTAL

Conservative treatment: pulpectomy and composite resin crown

Intervention Type: OTHER

tooth extraction

The technique of tooth extraction of primary teeth will be performed according to clinical guidelines

Group Type: EXPERIMENTAL

Non-conservative treatment: Tooth extraction

Intervention Type: OTHER

Interventions

Conservative treatment: pulpectomy and composite resin crown

Intervention Type: OTHER

Non-conservative treatment: Tooth extraction

Intervention Type: OTHER

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Jenny Abanto

Post-doctoral student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jenny Abanto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Other Identifiers

2013/10330-8

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

usp

Identifier Type: -

Identifier Source: org_study_id