Traumatic TeethNCT07236567
Revascularization of Young Immature Permenant Teeth Using Different Types of Intra Canal Medication
A study testing Grape Seed Extract, Glycyrrhizin and Triple Antibiotic Paste in people with Traumatic Teeth and Necrotic Teeth, run by Al-Azhar University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Traumatic Teeth, Necrotic Teeth
- What is being tested?
- Grape Seed Extract, Glycyrrhizin and Triple Antibiotic Paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children aged from 7-13 years old.
- Patient with necrotic pulp.
- Open apex.
Who cannot join
- Teeth with root fractures.
- Presence of root resorptions.
- Presence of periodontal pockets.
- Developmental anomalies.
- Tooth with class III mobility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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
Read the detailed description
Digital count of e.faecalis before and after application of different type of intra canal medication
- Conditions
- Traumatic Teeth, Necrotic Teeth
- Being tested
- Grape Seed Extract, Glycyrrhizin, Triple Antibiotic Paste
- Keywords
- Revascularization, Grape seed extract, Glycyrrhizin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape Seed ExtractDrug
Grape seed extract in form of hydrogel with concentration 6.5 % left in canal for one week
GlycyrrhizinDrug
Glycyrrhizin hydrogel 50 micrograms in 1 milligram left in canal for one week
Triple Antibiotic PasteDrug
Trple antibiotic paste Left for one week
| Study group | Role | What they receive |
|---|---|---|
| Group a | Active comparator | Revascularization with triple antibiotic paste as intracanal medication Receives: Drug: Triple Antibiotic Paste |
| Group b | Experimental | Revascularization with grape seed extract as intra canal medication Receives: Drug: Grape Seed Extract |
| Group c | Experimental | Revascularization with glycyrrhizin as intracanal medication Receives: Drug: Glycyrrhizin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital count of e.faecalis
Microbiological evaluation The number of E. faecalis will be digitally counted.
Measured: 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
- 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
Measured: After one week of mediation application
Secondary outcomes (1)
Radiographic evaluation
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
Measured: After tweleve month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic TeethStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Khalifa, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236567
- Sponsor's protocol ID
- Revascularization
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07236567
- Acronym / sponsor ID
- Revascularization
- Conditions
- Traumatic Teeth, Necrotic Teeth
- Keywords
- Revascularization, Grape seed extract, Glycyrrhizin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Digital count of e.faecalis before and after application of different type of intra canal medication
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group a | Active comparator | Drug: Triple Antibiotic PasteRevascularization with triple antibiotic paste as intracanal medication |
| Group b | Experimental | Drug: Grape Seed ExtractRevascularization with grape seed extract as intra canal medication |
| Group c | Experimental | Drug: GlycyrrhizinRevascularization with glycyrrhizin as intracanal medication |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children aged from 7-13 years old.
- Patient with necrotic pulp.
- Open apex.
Key exclusion criteria (5 listed)
- Teeth with root fractures.
- Presence of root resorptions.
- Presence of periodontal pockets.
- Developmental anomalies.
- Tooth with class III mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grape Seed ExtractGrape seed extract in form of hydrogel with concentration 6.5 % left in canal for one week | Drug | Group b |
| GlycyrrhizinGlycyrrhizin hydrogel 50 micrograms in 1 milligram left in canal for one week | Drug | Group c |
| Triple Antibiotic PasteTrple antibiotic paste Left for one week | Drug | Group a |
Primary outcome
Digital count of e.faecalis
Time frame: After One week of mediation application
Microbiological evaluation The number of E. faecalis will be digitally counted.
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
1 secondary outcome
Radiographic evaluation
Time frame: After tweleve month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- BackgroundEvaluation 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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape Seed Extract, Glycyrrhizin and Triple Antibiotic Paste in people with Traumatic Teeth and Necrotic Teeth, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Khalifa (+2010 69978846, dr.khalifa12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital count of e.faecalis (time frame: After One week of mediation application). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07236567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.