Conservative Versus Non-conservative Treatment for Severe Dental Caries

University of Sao Paulo

Status: Completed

Conditions: Dental Caries

Treatments: Other: Non-conservative treatment: Tooth extraction; Other: Conservative treatment: pulpectomy and composite resin crown

Study type: Interventional

Funder types: Other

Identifiers

NCT01858298

2013/10330-8 (Other Grant/Funding Number)

usp

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

pulpectomy

Experimental group

Description:

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

Treatment:

Other: Conservative treatment: pulpectomy and composite resin crown

tooth extraction

Experimental group

Description:

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

Treatment:

Other: Non-conservative treatment: Tooth extraction