A 24-month Outcomes of Single- Vs Multiple-visit Revascularization
Clinical and Radiographic Outcomes of Single- Versus Multiple-visit Revascularization of Asymptomatic Necrotic Immature Maxillary Permanent Incisors: a 24-month Randomized Clinical Trial
1 other identifier
interventional
86
1 country
1
Brief Summary
The current randomized clinical trial will be conducted to evaluate the 24-month clinical and radiographic outcomes after revascularization of asymptomatic necrotic immature permanent maxillary incisors using single- or multiple-visit protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 21, 2024
CompletedFirst Submitted
Initial submission to the registry
December 23, 2024
CompletedFirst Posted
Study publicly available on registry
January 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
ExpectedJanuary 8, 2025
December 1, 2024
2 months
December 23, 2024
January 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants experiencing Pain after treatment
Zero is equivalent to no pain and 1 indicates presence of pain that necessitate taking pain killer
From enrollment to the end of treatment at 24 months
Study Arms (2)
Single-visit revascularization
EXPERIMENTALRevascularization protocol will be performed in single visit
multiple-visit revascularization
ACTIVE COMPARATORRevascularization protocol will be performed in multiple visits
Interventions
Revascularization protocol will be performed in single visit
Revascularization protocol will be performed in multiple visit
Eligibility Criteria
You may qualify if:
- Compliant healthy patients who had at least one immature maxillary permanent incisor requiring nonsurgical root canal treatment.
- Patients presenting with a diagnosis of pulp necrosis with chronic apical periodontitis confirmed by history, clinical, radiographic and operative examination.
- Patient without previous endodontic treatment in affected tooth.
You may not qualify if:
- Patients with systemic conditions (medical, developmental or behavioral) that make routine dental treatment difficult.
- Patients taking medications that can interfere with healing or hemostasis.
- Patients with allergy to local anesthetics
- Children who will not comply to recall program.
- Teeth with extensive loss of coronal tissue that require restoration with a post
- Teeth with internal or external root resorption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (1)
Minia University Dental Hospita
Minya, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- biostatistician
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Pediatric Dentistry
Study Record Dates
First Submitted
December 23, 2024
First Posted
January 8, 2025
Study Start
December 21, 2024
Primary Completion
March 1, 2025
Study Completion (Estimated)
March 1, 2027
Last Updated
January 8, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share
Ethical Considerations