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NCT Number: NCT07236567

Revascularization of Young Immature Permenant Teeth Using Different Types of Intra Canal Medication

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

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Key information

Conditions

Traumatic Teeth Necrotic Teeth

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University faculty of dental medicine

Cairo, Egypt

About this study

Digital count of e.faecalis before and after application of different type of intra canal medication

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grape Seed Extract

Drug

Grape seed extract in form of hydrogel with concentration 6.5 % left in canal for one week

Glycyrrhizin

Drug

Glycyrrhizin hydrogel 50 micrograms in 1 milligram left in canal for one week

Triple Antibiotic paste

Drug

Trple antibiotic paste Left for one week

Primary outcomes

  1. Digital count of e.faecalis

    Time frame: After One week of mediation application

    Microbiological evaluation The number of E. faecalis will be digitally counted.

  2. 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
    • asymptomatic Pathology: absent Normal functioning Mobility (physiological) ≤1mm
    • Slight discomfort, short-lived Pathology: questionable Percussion sensitivity Gingival inflammation (due to poor oral hygiene) Mobility (physiological) > 1mm, but <2mm
    • Minor discomfort, short-lived Pathology: initial changes present Gingival swelling (not due to poor oral hygiene) Mobility > 2mm, but < 3 mm
    • 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Khalifa

CONTACT

[email protected]

+2010 69978846

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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