- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06785961
Healing Assessment of External Inflammatory Root Resorption After Revascularization Technique of Avulsed Permanent Central Incisor (Case Study) ((EIRR))
January 20, 2025 updated by: Abdelrhaman Reda Elshair, Badr University
Evaluate the healing of external root resorption of replanted avulsed permanent maxillary central incisor after revascularization.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Healing assessment of external inflammatory Root Resorption after Revascularization Technique of Avulsed permanent Central Incisor (Case study)
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cairo
-
Badr, Cairo, Egypt, 11829
- Badr University in Cairo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- traumatic teeth
- external inflammatory root resorption
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single- arm
Case study
|
Revascularization is a new treatment method for immature necrotic , pulp revascularization allows also the stimulation of the apical development and the root maturation of immature teeth ( growth and thickening of dentinal walls ).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure amount of bone healing and root formation by using cone beam computed tomography (CBCT)
Time Frame: 18 months
|
Measure amount of bone healing and root formation by using measuring tool cone beam computed tomography (CBCT) By using measuring unit hounsfield unit (HU)
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measuring pain by using the numeric pain rating scale
Time Frame: 18 months
|
Measuring pain by using the numeric pain rating scale, through patient is asked to make three pain rating, the average of three ratings was used to represent the patient's level of pain (0 none) (1-3 mild) (4-6 moderate) (7-10 severe)
|
18 months
|
|
Pulp test to assess the vitality or health of the dental pulp
Time Frame: Every 6 months
|
Pulp test to assess the vitality or health of the dental pulp through measuring tool thermal pulp test :applied to the tooth to assess the response.
The unit of measurement here is typically °C (degrees Celsius) .
|
Every 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2024
Primary Completion (Estimated)
August 31, 2025
Study Completion (Estimated)
August 31, 2025
Study Registration Dates
First Submitted
December 8, 2024
First Submitted That Met QC Criteria
January 20, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 20, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BUC-IACUC-241020-113
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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