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

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

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 :

  • Pain,
  • Soft tissue swelling
  • soft tissue inflammation
  • Sinus tract
  • tenderness to percussion
  • tooth mobility. Clinical score Clinical symptom Definition

    1. asymptomatic Pathology: absent Normal functioning Mobility (physiological) ≤1mm
    2. Slight discomfort, short-lived Pathology: questionable Percussion sensitivity Gingival inflammation (due to poor oral hygiene) Mobility (physiological) > 1mm, but <2mm
    3. Minor discomfort, short-lived Pathology: initial changes present Gingival swelling (not due to poor oral hygiene) Mobility > 2mm, but < 3 mm
    4. Major discomfort, long-lived extract immediately Pathology: late changes present Spontaneous pain Gingival swelling (not due to poor oral hygiene) Periodontal pocket formation(exudate) Sinus tract present Mobility ≥ 3mm Premature tooth loss, due to pathology
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.

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

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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