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
About this trial
This is an interventional treatment trial for Dental Pulp Necroses focused on measuring Pulpectomy, single visit, two visits
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
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
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
Learn more about this trial
Single and Two-visit Pulpectomy in Primary Molars
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