NCT07236567

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Dec 2025Nov 2027

First Submitted

Initial submission to the registry

November 15, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1.8 years

First QC Date

November 15, 2025

Last Update Submit

November 15, 2025

Conditions

Traumatic TeethNecrotic Teeth

Keywords

RevascularizationGrape seed extractGlycyrrhizin

Outcome Measures

Primary Outcomes (2)

  • Digital count of e.faecalis

    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

    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 Outcomes (1)

  • Radiographic evaluation

    After tweleve month

Study Arms (3)

Group a

ACTIVE COMPARATOR

Revascularization with triple antibiotic paste as intracanal medication

Drug: Triple Antibiotic Paste

Group b

EXPERIMENTAL

Revascularization with grape seed extract as intra canal medication

Drug: Grape Seed Extract

Group c

EXPERIMENTAL

Revascularization with glycyrrhizin as intracanal medication

Drug: Glycyrrhizin

Interventions

Grape Seed ExtractDRUG

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

Group b
GlycyrrhizinDRUG

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

Group c
Triple Antibiotic PasteDRUG

Trple antibiotic paste Left for one week

Group a

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children aged from 7-13 years old.
  • Patient with necrotic pulp.
  • Open apex.

You may not qualify if:

  • Teeth with root fractures.
  • Presence of root resorptions.
  • Presence of periodontal pockets.
  • Developmental anomalies.
  • Tooth with class III mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University faculty of dental medicine

Cairo, Egypt

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Interventions

Grape Seed ExtractGlycyrrhizic Acid

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex MixturesPharmaceutical PreparationsPentacyclic TriterpenesTriterpenesTerpenesHydrocarbonsOrganic Chemicals

Central Study Contacts

Mohamed Khalifa

CONTACT

+2010 69978846dr.khalifa12@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of dental medicine

Study Record Dates

First Submitted

November 15, 2025

First Posted

November 19, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations

EG(1)