Pomegranate Peel Extract for Primary Molar Pulpotomy

Not Applicable

Not yet recruiting

• Conditions: Pulpitis Reversible; Pulp Exposure, Dental

• Registration Number: NCT07108738
• Lead Sponsor: Tanta University

Brief Summary

Pomegranate peel extract has demonstrated a range of potential uses in the biomedical industry in recent years because of its numerous benefits, which include anti-inflammatory, antibacterial, anti-apoptotic, antioxidant, and cell-regeneration-promoting qualities. Therefore, the purpose of this study will be to evaluate the clinical and radiographic efficacy of Pomegranate peel extract as a pulpotomy agent in primary teeth.

Detailed Description

A total of sixty primary molars in thirty children aged between 4 and 8 years will be randomly divided into two groups: Group I, the Pomegranate peel extract group, and Group II, the MTA group. After pulpotomy treatment, all molars will be restored with stainless steel crowns. Follow-up will be done after 3, 6, and 9 months for clinical and radiographic assessment.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-31
• Study First Submitted QC: 2025-07-31
• Last Update Submitted: 2025-07-31
• Study Start: 2025-08-01
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-07
• Primary Completion: 2026-03
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Restorable primary molars with deep carious lesions.
• Absence of gingival swelling or sinus tract.
• Absence of spontaneous pain
• Absence of pain on percussion.
• Absence of discontinuity of lamina dura
• Absence of internal root resorption.
• Absence of external root resorption.
• Absence of inter-radicular or periapical bone destruction (radiolucency).

Exclusion Criteria

• presence of spontaneous pain
• presence of gingival swelling or sinus tract
• presence of internal or external root resorption
• pain on percussion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
absence of pain	up to 9 months	Measuring Method: Verbal Question to Patient /Parents Measuring Unite: score 0 for absence of pain and score 1 for presence of pain
furcation radiolucency	9 months	Description: Measuring Method: periapical x-ray for assessment of radio-density of bone at the furcation area, Measuring Unit: mean value of gray level (which measures density scale between 0 to 256, with zero being the lowest value and 256 the highest dense value)
absence of fistula	up to 9 months]	Measuring Method: Visual examination by operator Measuring Unit: score 0 for absence of swelling and score 1 for presence of swelling
Tenderness to percussion	up to 9 months	Measuring Method: Percussion test Measuring Unite: Binary (+/-)
Furcation radiolucency	3 months	Measuring Method: periapical x-ray for assessment of radio-density of bone at the furcation area, Measuring Unit: mean value of gray level (which measures density scale between 0 to 256, with zero being the lowest value and 256 the highest dense value)

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Egypt