Clinical trial NCT05589025: Pulpotomy Versus Pulpectomy in Vital Primary Incisors
Official title: Pulpotomy Versus Pulpectomy in Carious Vital Pulp Exposure of Primary Incisors: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Pulp Disease, Dental
Keywords: pulpotomy
pulpectomy
tooth, deciduous
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2022-10-21
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split mouth
Primary purpose: TREATMENT

Brief summary: The aim of this split mouth randomized controlled study was to compare formocresol pulpotomy and zinc-oxide and eugenol pulpectomy in the treatment of vital pulp exposure in primary incisor. 39 Contralateral pairs of incisors were randomly assigned to receive pulpotomy or pulpectomy in children aged from 18 to 66 months old.

Clinical and radiographical evaluations were performed at 6 and 12 months

Detailed description: * This randomized controlled trial with split mouth design
* The study was approved by the research ethics committee of the National research centre.
* Participants in this study were recruited from August 2015 till December 2016. Patients' eligibility criteria were medically free patients, aging from 18 to 66 months old, with two or more carious vital primary maxillary incisors where exposure of the vital pulp following the removal of dental caries was inevitable.
* Sample size was calculated using PS Computer Program .A study of matched cases and controls was planned. Prior data indicated that success rates among controls were 0.78 . If the true success rate for experimental subjects is 1, then we needed to study 31 pairs to be able to reject the null hypothesis that the success rates for experimental and control subjects are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05.McNemar's chi-squared statistic was used to evaluate this null hypothesis. This number has been increased to a total sample size 39 in each group, to allow for losses of around 25%.
* The procedure, possible discomforts or risks, as well as possible benefits were explained completely to the parents or legal guardians, and they were allowed to sign in the patients' ethics form.
* The child participants and legal guardian of each participating child were blinded to the type of treatment they received while it was not possible for the operator or the radiographic assessors to be blinded due to the nature of the treatment received.
* An incisor in each pair was randomly assigned by a coin toss to either the intervention (pulpotomy group) on the head side or the control (pulpectomy group) on the tail side with the contralateral paired incisor being designated to the other treatment group.
* Clinical examination and preoperative periapical radiographs were performed for eligible patients. After induction of anesthesia, teeth were properly isolated with cotton rolls and suction as rubber dam was not tolerated by children less than 6 years of age. Complete removal of caries or undermined enamel was performed before access cavity preparation.•
* For follow up: Clinical evaluation was performed on all primary incisors during the follow-up visits at one, six and twelve months post-operatively while radiographic evaluation was performed at six and twelve months follow up visits
* For radiographic evaluation, the radiographs were taken with a size 0 or 1 periapical films (D-speed Film, Ultra-speed Carestream Dental,USA) using the bisecting angle technique. The radiographs were scanned on a viewer and transmitted to a computer hardware to be properly saved. The evaluation was performed by two independent assessors and differences were solved by consensus. Data analysis was performed on the consensus scores.
* For Statistical analysis, Chi square test was used to compare between the two groups. The significance level was set at P ≤ 0.05. Also estimated effect size was calculated with 95% Confidence Interval. Kaplan-Meier used for survival analysis. Statistical analysis was performed with IBM® SPSS® (SPSS Inc., IBM Corporation, NY, USA) .

Eligibility criteria: Inclusion Criteria:

* Two or more carious vital primary maxillary incisors where exposure of the vital pulp following the removal of dental caries was inevitable.
* No history of spontaneous pain
* No lingering provoked pain
* No pain on percussion, No fistula, or sinus tract
* No history of trauma
* No periapical radiolucency
* No pathologic root resorption
* No pulp calcification.

Exclusion Criteria:

* Teeth with physiologic resorption exceeding one-third of the root
* Teeth non-restorable with crowns.

Primary outcomes:
measure: clinical failure
timeFrame: 1 year
measure: radiographic failure
timeFrame: 1 year
Secondary outcomes:
measure: survival rate
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: National Research Centre, Egypt
name: Lamia Gadallah, Researcher
role: PRINCIPAL_INVESTIGATOR
References:
citation: Howley B, Seale NS, McWhorter AG, Kerins C, Boozer KB, Lindsey D. Pulpotomy versus pulpectomy for carious vital primary incisors: randomized controlled trial. Pediatr Dent. 2012 Sep-Oct;34(5):112-9.
citation: Aminabadi NA, Farahani RM, Gajan EB. A clinical study of formocresol pulpotomy versus root canal therapy of vital primary incisors. J Clin Pediatr Dent. 2008 Spring;32(3):211-4. doi: 10.17796/jcpd.32.3.ghk26v4554790074.
citation: Smail-Faugeron V, Fron Chabouis H, Durieux P, Attal JP, Muller-Bolla M, Courson F. Development of a core set of outcomes for randomized controlled trials with multiple outcomes--example of pulp treatments of primary teeth for extensive decay in children. PLoS One. 2013;8(1):e51908. doi: 10.1371/journal.pone.0051908. Epub 2013 Jan 3.