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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
National Research Centre, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring pulpotomy, pulpectomy, tooth, deciduous

Eligibility Criteria

18 Months - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 10, 2022
    Last Updated
    October 17, 2022
    Sponsor
    National Research Centre, Egypt
    Collaborators
    Cairo University
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    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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