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
| Registry | NCT07236567 |
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| Status | Not yet recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, treatment |
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| Enrollment | 45 (Estimated) |
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| Sponsor | Al-Azhar University (Other) |
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| Conditions | Traumatic Teeth, Necrotic Teeth |
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| Interventions | Grape Seed Extract, Glycyrrhizin, Triple Antibiotic Paste (Drug) |
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| Dates | start 2025-12-01 (estimated), primary completion 2027-10-01 (estimated), completion 2027-11-01 (estimated), first posted 2025-11-19, last updated 2025-11-19 |
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| Locations | 1 site in Egypt |
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-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
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+Detailed description
Digital count of e.faecalis before and after application of different type of intra canal medication
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Group a | Active comparator | Drug: Triple Antibiotic Paste | Revascularization with triple antibiotic paste as intracanal medication |
| Group b | Experimental | Drug: Grape Seed Extract | Revascularization with grape seed extract as intra canal medication |
| Group c | Experimental | Drug: Glycyrrhizin | Revascularization with glycyrrhizin as intracanal medication |
- 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
+Outcome measures
Primary outcomes
- Digital count of e.faecalis [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 [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
Secondary outcomes
- Radiographic evaluation [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
+Eligibility
Sex: All, ages: 7 Years to 13 Years
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
+Locations (1)
| Facility | City | Country | Status |
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| Al-Azhar University faculty of dental medicine | Cairo | Egypt | |
+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