Abstract
Abstract
Study design
A randomised parallel controlled clinical trial was conducted between 2013 and 2015 at the University of Sao Paulo, Brazil, to assess the impact of pulpectomy or extraction on the oral health-related quality of life (OHRQoL) of children with pulp necrosis in primary molars.
Study selection
Children between the ages of 3 and 5 who were in good health but had extensive caries in at least one primary molar with signs of pulpal necrosis (also as seen radiographically, caries reaching the pulp with no signs of internal or external resorption) were considered for inclusion. Additionally, teeth with sufficient structure for rubber dam placement were also included. Children with any systemic, neurological, or other conditions that negatively impacted their growth were excluded.
Clinical procedures and success criteria
After computer-generated randomisation, 100 children were assigned randomly into two groups: 50 in the pulpectomy group and 50 in the dental extraction group. A paediatric dentist performed all procedures under local anaesthesia without sedation or general anaesthesia, and a rubber dam was used for pulpectomy with composite restoration in a single session. The OHRQoL scores were evaluated at baseline, 4, 8, and 12 months using the Brazilian version of the Early Childhood Oral Health Impact Scale (B-ECOHIS) via face-to-face interviews with parents conducted by a researcher trained in a single-blinded fashion. Additionally, the child’s self-reported dental anxiety was measured using the Facial Image Scale (FIS), and dental pain was assessed using the Wong-Baker Faces Pain Scale (WBFPS) immediately after the treatment as secondary outcomes.
Results
The mean difference (SD) in the total B-ECOHIS score between baseline and after 12 months was 12.66 (6.79) for the pulpectomy group and 10.94 (9.28) for the extraction group, with effect sizes of 3.2 (95% CI: 2.42–4.20) and 1.4 (95% CI: 0.84–2.11), respectively. While both treatments significantly improved the children’s OHRQoL after 12 months, the pulpectomy group showed greater long-term improvement compared to the extraction group, with mean differences (SD) of 4.86 (6.13) and effect sizes of 0.8 (0.46–1.13; p < 0.001). Moreover, children in the extraction group showed higher levels of anxiety compared with those in the pulpectomy group at 12-month follow-up (OR = 2.52; 95% CI = 1.30–4.89), and they reported 93% more odds of ‘dental pain with high level’ immediately after treatment than those in the pulpectomy group (OR = 1.93; 95% CI = 0.83–4.49).
Conclusion
Children treated with pulpectomy in their necrotic primary molars were found to have better OHRQoL than those who had their primary molars extracted.
Publisher
Springer Science and Business Media LLC
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