Clinical Trials in Egypt / NCT07417098
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CGF Partial Pulpotomy Versus Endodontic Treatment
NCT07417098 · tracked via the Priya Life Science Egypt tracker
Condition(s) studied
Irreversible Pulpitis
Investigational drug(s) / intervention(s)
Other treatmentOther treatment
Other treatment: partial pulpotomy using CGF in irreversibly inflamed mature molars in adolescents
Other treatment: endodontic treatment using guttapercha in irreversibly inflamed molars in adolescents
Study summary
partial pulpotomy of mature molars with irrevesible pulptits using CGF in adolescents
Eligibility
Inclusion Criteria:
* Patient-based criteria: Class ASA I or II cooperative adolescents of 11 - 17 years. Based on a 10 cm modified visual analog scale (VAS), only patients who reported a preoperative pain intensity score of ≥ 7, indicative of severe pain were included.
Tooth-based criteria: Presence of occlusal extremely deep carious lesion with pulp exposure of mandibular first permanent molars with closed apices (i.e. class V according to Cvek's stages of root development) with sound contralateral molars to provide a reference for biomarker quantification and pulp sensibility tests. Only teeth diagnosed with symptomatic irreversible pulpitis (SIP) were included. To validate the diagnosis of SIP, the teeth with the teeth diagnosed with symptomatic irreversible pulpitis (SIP) were included. To validate the diagnosis of SIP, the teeth with the following criteria were exclusively included:
1. History of sharp, spontaneous, and lingering pain that was precipitated by thermal provocation and lasted mostly for ≥ 30 seconds.
2. Early prolonged, intense, and lingering response to cold thermal stimulus and positive response electric pulp test (EPT) at low thresholds.
3. Normal color and appearance of the tooth surrounding gingival tissues with no evidence of gingival inflammation, swelling, abnormal tooth mobility, or sinus tract or fistula formation upon visual and palpation inspections.
4. Preoperative periapical radiograph with evidence of caries penetrating the entire thickness of the dentin with no isolating radiopaque zone separating the lesion from the pulp indicating extremely deep caries.
5. Normal radiographic findings in terms of intact periodontal membrane space
Exclusion Criteria:
Patient-based criteria: Patients with a positive history of the following conditions were excluded:
1. Emotional or behavioral problems and those receiving antidepressant drugs.
2. Under treatment with antibacterial or anti-inflammatory medicaments for the last four weeks (Akbal Dincer et al., 2020).
3. Localized or generalized gingivitis and/or periodontitis with loss of epithelial attachment ≥ 3mm upon probing.
4. Poor oral hygiene with dense accumulation of calculus or dental plaque.
5. Systemic conditions such as diabetes, bleeding, immunological disorders.
Tooth-based criteria:
1. Teeth with abnormal structure or developmental anomalies.
2. Persistent hemorrhage from the root canal orifices lasting longer than 10 minutes.
3. Loss of coronal structure beyond restorability
Primary outcome measure(s)
- The primary outcome was to compare the cumulative pain responses using modified VAS scores. — one week
The primary outcome was to compare the cumulative pain responses using modified VAS scores which has a scale from 0 -10 after partial pulpotomy using CGF versus Endodontic treatment throughout one week of follow-up period. - Pulpal blood biomarkers — one week
Measuring Biomarker levels via quantifying NKA, SP, IL-8, and MMP-8 in pg/ml blood after partial pulpotomy using CGF versus Endodontic treatment throughout one week of follow-up period
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Pediatric and Community Dentistry Department , Faculty of Dentistry , Minia University | Minya | Minia City |
More Minia University trials in Egypt
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Postoperative Pain After Pulpectomy in Primary Molars
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07417098 on ClinicalTrials.gov ↗ ← All trials in Egypt