Pulpotomy Versus Pulpectomy in Vital Primary Incisors
Primary Purpose
Dental Caries, Pulp Disease, Dental
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pulpotomy technique with formocresol
pulpectomy technique with zinc oxide and eugenol
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring pulpotomy, pulpectomy, tooth, deciduous
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
treatment group
control group
Arm Description
pulpotomy: amputation of coronal pulp
Pulpectomy: complete removal of the pulp tissues from the canals
Outcomes
Primary Outcome Measures
clinical failure
composite outcome including pain, soft tissue pathology, and tooth mobility. All are binary outcomes. The presence of any item is recorded as a clinical failure.
radiographic failure
a composite outcome including pathologic mobility and pathologic root resorption. Both are binry outcomes, the presence of any of them is recorded as a radiographic failure.
Secondary Outcome Measures
survival rate
the survival of the tooth in the oral cavity
Full Information
NCT ID
NCT05589025
First Posted
October 10, 2022
Last Updated
October 17, 2022
Sponsor
National Research Centre, Egypt
Collaborators
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT05589025
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
December 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Centre, Egypt
Collaborators
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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) .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Pulp Disease, Dental
Keywords
pulpotomy, pulpectomy, tooth, deciduous
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
split mouth
Masking
ParticipantOutcomes Assessor
Masking Description
blinding of assessor of clinical outcomes
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Active Comparator
Arm Description
pulpotomy: amputation of coronal pulp
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Pulpectomy: complete removal of the pulp tissues from the canals
Intervention Type
Procedure
Intervention Name(s)
pulpotomy technique with formocresol
Other Intervention Name(s)
vital pulp therapy
Intervention Description
The pulpotomy procedure performed was a modification of that described by Pinkham et al; 2005 where pulp chamber was unroofed using a no. 330 sterile bur in a water-cooled high-speed handpiece. The entire roof of pulp chamber and overhanging dentinal remnants over the pulp horns were removed. After the completion of the access cavity, coronal pulp was extirpated using a sharp excavator. Any residual coronal pulpal tissue was removed using a sterile round bur in a slow-speed handpiece to a depth of few millimeters below the free gingival margin. Hemostasis was achieved with a water-dampened cotton pellet. If hemostasis was not achieved after the initial application of the cotton pellet, the case was eliminated from the study. Following hemostasis, a cotton pellet, moistened with formocresol was applied for 3 minutes and removed. A zinc- oxide and eugenol base was placed over the amputation site. Thereafter, a glass ionomer base was applied.
Intervention Type
Procedure
Intervention Name(s)
pulpectomy technique with zinc oxide and eugenol
Other Intervention Name(s)
root canal treatment
Intervention Description
The pulpectomy procedure used herein was a modification of that described by Payne et al;1993 Pulp chamber was unroofed using a no. 330 sterile bur in a water-cooled high-speed handpiece. The entire roof of pulp chamber and overhanging dentinal remnants over the pulp horns were removed. An initial endodontic K-file fitting snugly in the canal was introduced inside it. In most cases, the pulp tissue was removed completely on the first attempt. If the first attempt was unsuccessful, the procedure was repeated and canals were generally enlarged three sizes past the initial file to eliminate the organic remnants. Copious irrigation with a light flow of sterile 0.9% NaCl-solution was used throughout the procedure. At the end, the canals were dried and filled with zinc-oxide & eugenol.
Primary Outcome Measure Information:
Title
clinical failure
Description
composite outcome including pain, soft tissue pathology, and tooth mobility. All are binary outcomes. The presence of any item is recorded as a clinical failure.
Time Frame
1 year
Title
radiographic failure
Description
a composite outcome including pathologic mobility and pathologic root resorption. Both are binry outcomes, the presence of any of them is recorded as a radiographic failure.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
survival rate
Description
the survival of the tooth in the oral cavity
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lamia Gadallah, Researcher
Organizational Affiliation
National Research Centre, Egypt
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
the required data will be published in the study
Citations:
PubMed Identifier
23211895
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.
Results Reference
background
PubMed Identifier
18524271
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.
Results Reference
background
PubMed Identifier
23300955
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.
Results Reference
background
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Pulpotomy Versus Pulpectomy in Vital Primary Incisors
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