Conservative Versus Non-conservative Treatment for Severe Dental Caries

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Other: Conservative treatment: pulpectomy and composite resin crown; Other: Non-conservative treatment: Tooth extraction

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: pulpectomy; The technique of pulpectomy will be performed in one appointment according to clinical guidelines and followed by a composite resin crown.	Other: Conservative treatment: pulpectomy and composite resin crown
EXPERIMENTAL: tooth extraction; The technique of tooth extraction of primary teeth will be performed according to clinical guidelines	Other: Non-conservative treatment: Tooth extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oral health-related quality of life	- OHRQoL instruments: Brazilian SOHO-5 Brazilian ECOHIS	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anthropometric measures	Weight-for-age Z-score (WAZ); Height-for-age Z-score (HAZ); BMI-for age Z-score (BAZ)	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	12 months
dental anxiety	Scale anxiety using the Facial Image Scale	12 months
Dental pain	The Wong-Baker Faces Pain Scale will be used to asses dental pain	12 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: University College, London; Federal University of Minas Gerais
• Investigators: Principal Investigator: Jenny Abanto, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: May 9, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (ESTIMATE): May 21, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Quality of Life; Pulpectomy; Dental caries; Tooth extraction
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: USP; 2013/10330-8 (OTHER_GRANT: Processo FAPESP)