- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07236567
Revascularization of Young Immature Permenant Teeth Using Different Types of Intra Canal Medication
November 15, 2025 updated by: Mohamed Khalifa, Al-Azhar University
Evaluation of the Effect of Grape Seed Extract, Glycyrrhizin Compared to Triple Antibiotic Paste as Intra Canal Medication in Revascularization of Necrotic Permanent Immature Teeth in Children: A Randomized Clinical Trial
Evaluation of the Effect of Grape Seed Extract, Glycyrrhizin Compared to Triple Antibiotic Paste as Intra Canal Medication in Revascularization of Necrotic Permanent Immature Teeth in Children: A Randomized Clinical Trial
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Digital count of e.faecalis before and after application of different type of intra canal medication
Study Type
Interventional
Enrollment (Estimated)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed Khalifa
- Phone Number: +2010 69978846
- Email: dr.khalifa12@gmail.com
Study Locations
-
-
-
Cairo, Egypt
- Al-Azhar University faculty of dental medicine
-
-
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
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Healthy children aged from 7-13 years old.
- Patient with necrotic pulp.
- Open apex.
Exclusion Criteria:.
- Teeth with root fractures.
- Presence of root resorptions.
- Presence of periodontal pockets.
- Developmental anomalies.
- Tooth with class III mobility
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group a
Revascularization with triple antibiotic paste as intracanal medication
|
Trple antibiotic paste Left for one week
|
|
Experimental: Group b
Revascularization with grape seed extract as intra canal medication
|
Grape seed extract in form of hydrogel with concentration 6.5 % left in canal for one week
|
|
Experimental: Group c
Revascularization with glycyrrhizin as intracanal medication
|
Glycyrrhizin hydrogel 50 micrograms in 1 milligram left in canal for one week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Digital count of e.faecalis
Time Frame: After One week of mediation application
|
Microbiological evaluation The number of E. faecalis will be digitally counted.
|
After One week of mediation application
|
|
Clinical evaluation success will be assessed using following criteria of success according to scoring system Absence of : - Pain, - Soft tissue swelling - soft tissue inflammation - Sinus tract - tenderness to percussion - tooth mobility
Time Frame: After one week of mediation application
|
Clincal success will be assessed using following criteria of success according to clinical scoring system Absence of :
|
After one week of mediation application
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiographic evaluation
Time Frame: After tweleve month
|
After tweleve months take periapical radiograph to detection normal lamina dura and increase in root thikness and length.
Criteria for success according to radiographic scoring system
|
After tweleve month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Evaluation of the Effect of Grape Seed Extract, Glycyrrhizin Compared to Triple Antibiotic Paste as Intra Canal Medication in Revascularization of Necrotic Permanent Immature Teeth in Children: A Randomized Clinical Trial
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 (Estimated)
December 1, 2025
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
November 1, 2027
Study Registration Dates
First Submitted
November 15, 2025
First Submitted That Met QC Criteria
November 15, 2025
First Posted (Actual)
November 19, 2025
Study Record Updates
Last Update Posted (Actual)
November 19, 2025
Last Update Submitted That Met QC Criteria
November 15, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Revascularization
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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