Actively Recruiting
Clinical and Radiographic Outcomes of Single- Versus Multiple-visit Revascularization of Asymptomatic Necrotic Immature Maxillary Permanent Incisors: a 24-month Randomized Clinical Trial
Led by Minia University · Updated on 2025-01-08
86
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the outcomes of two different revascularization treatments for children aged 7 to 13 with necrotic immature permanent maxillary incisors that show no symptoms. The trial aims to compare the clinical and radiographic results over 24 months following either a single-visit or multiple-visit protocol. This trial is a randomized clinical study led by Minia University to determine how these approaches affect healing and tooth health. Participants will receive either a single-visit revascularization procedure or a multiple-visit revascularization procedure. Each treatment protocol is designed to restore the affected tooth without surgery by encouraging natural healing. The study will observe and compare these two methods over a 24-month period to evaluate their effectiveness and outcomes. During the study, participants will be monitored for any pain experienced after treatment, with assessments continuing from enrollment through the full 24 months. Clinical and radiographic examinations will be carried out to evaluate healing progress and tooth condition. The trial includes regular follow-ups to track changes and ensure patient safety throughout the study duration.
CONDITIONS
Brief Title
A 24-month Outcomes of Single- Vs Multiple-visit Revascularization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Compliant healthy patients with at least one immature maxillary permanent incisor needing nonsurgical root canal treatment
- Diagnosis of pulp necrosis with chronic apical periodontitis confirmed by history, clinical, radiographic, and operative examination
- No previous endodontic treatment on the affected tooth
You will not qualify if you...
- Patients with systemic medical, developmental, or behavioral conditions that make routine dental treatment difficult
- Patients taking medications that affect healing or blood clotting
- Allergy to local anesthetics
- Children who will not comply with the recall program
- Teeth with extensive loss of coronal tissue requiring restoration with a post
- Teeth with internal or external root resorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single-visit or multiple visits as per protocol
Participants receive revascularization treatment either in a single visit or multiple visits according to their assigned group.
1 visit for single-visit group or multiple visits for multiple-visit group
Duration - Up to 24 months
Participants are followed for up to 24 months to monitor pain and other outcomes after treatment.
Periodic follow-up visits during 24 months
Trial Site Locations
Total: 1 location
1
Minia University Dental Hospita
Minya, Egypt
Actively Recruiting
Research Team
G
Gad El-Hak, Lecturer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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