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Single and Two-visit Pulpectomy in Primary Molars

Primary Purpose

Dental Pulp Necroses

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Single and two visits pulpectomy
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pulp Necroses focused on measuring Pulpectomy, single visit, two visits

Eligibility Criteria

5 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Cooperative 5-8 years old children with no systemic diseases or chronic conditions. _Every child should have bilateral necrotic primary molars indicated for pulpectomy with sufficient coronal tooth structure. Exclusion Criteria: Children received antibiotics in the past month before the study. Primary molars with sinus tract, abscess, or facial cellulitis. Primary molas with root resorption exceeding one third of root length

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    single visit

    Two visits

    Arm Description

    Necrotic primary molar treated in single visit

    Necrotic primary molar treated in two visits

    Outcomes

    Primary Outcome Measures

    Clinical and Radiographic outcomes
    Proportion of clinical and radiographic success in both treatment protocols

    Secondary Outcome Measures

    Full Information

    First Posted
    October 1, 2023
    Last Updated
    October 1, 2023
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06071663
    Brief Title
    Single and Two-visit Pulpectomy in Primary Molars
    Official Title
    Clinical and Radiographic Evaluation of Single-Versus Two-visit Pulpectomy in Primary Molars: Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 5, 2023 (Anticipated)
    Primary Completion Date
    January 5, 2024 (Anticipated)
    Study Completion Date
    October 5, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A total of 64 primary molars of 5-8 years old children will be randomly selected from Pediatric dental clinic at Faculty of Dentistry, Mansoura University. Children will have two bilateral carious primary molars indicated for pulpectomy ; One side will be treated in one visit and the other will be treated in two visits. Clinical and radiographic evaluation for 3 , 6, 12 months
    Detailed Description
    All the pulpectomy steps will be carried out by a single operator. After confirming the diagnosis clinically and radiographically, the necrotic tooth will be anesthetized by local anesthesia and isolated by rubber dam. Caries will be removed by sterile round diamond burs. Proper access cavity will be prepared with complete deroofing and the pulp chamber will be irrigated by saline 0.9%. The working length will be established by apex locator and confirmed by periapical film (1 mm short of radiographic apex). Mechanical instrumentation will be done using rotary files followed by irrigation with no excessive pressure between files using sodium hypochlorite 2.5%. Then, root canal system will be dried by sterile paper points. In case of single visit pulpectomy (21): Root canals will be obturated by metapex and the tooth will be finally restored by glass ionomer filling and stainless-steel crown. In case of two visit pulpectomy (13): First, root canals will be filled by calcium hydroxide powder mixed with saline followed by temporary coronal restoration and left for 7 days. In the second visit, calcium hydroxide will be removed from the canals using K -files then irrigated by NaOCL 2.5%. The canals will be dried by sterile paper points before obturation and final restoration as mentioned in single- visit treatment protocol. A postoperative periapical x-ray film will be taken for future review. Clinical and radiographic follow up will be carried out after 3, 6, 12 months respectively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Pulp Necroses
    Keywords
    Pulpectomy, single visit, two visits

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    single visit
    Arm Type
    Active Comparator
    Arm Description
    Necrotic primary molar treated in single visit
    Arm Title
    Two visits
    Arm Type
    Active Comparator
    Arm Description
    Necrotic primary molar treated in two visits
    Intervention Type
    Procedure
    Intervention Name(s)
    Single and two visits pulpectomy
    Intervention Description
    Comparison of clinical and radiographic outcome of Single and two visits pulpectomy
    Primary Outcome Measure Information:
    Title
    Clinical and Radiographic outcomes
    Description
    Proportion of clinical and radiographic success in both treatment protocols
    Time Frame
    3 , 6 and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Cooperative 5-8 years old children with no systemic diseases or chronic conditions. _Every child should have bilateral necrotic primary molars indicated for pulpectomy with sufficient coronal tooth structure. Exclusion Criteria: Children received antibiotics in the past month before the study. Primary molars with sinus tract, abscess, or facial cellulitis. Primary molas with root resorption exceeding one third of root length
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Moustafa Omar, Bachelor of Dentistry
    Phone
    01062685288
    Email
    ahmedwael241014@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mahmoud Mahmoud Shaaban, Bachelor of Dentistry
    Phone
    01012342048
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nadia Moustafa Fareag, Professor
    Organizational Affiliation
    Pediatric dentistry department. MANSOURA UNIVERSITY
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Single and Two-visit Pulpectomy in Primary Molars

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