Pomegranate Peel Extract for Primary Molar Pulpotomy

Exploring Natural Alternatives: Pomegranate Peel Extract for Primary Molar Pulpotomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulp Exposure, Dental; Pulpitis Reversible
• Intervention / Treatment: Procedure: Pulpotomy; Procedure: Radiation

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: shaimaa eldesouky, assistant professor; Phone Number: +201008994242; Email: shaimaaeldesouky@dent.tanta.edu.eg

Study Locations

• Egypt
  • Tanta, Egypt
    • Tanta university
    • Contact: shaimaa eldesouky, assistant professor; Phone Number: 01008994242; Email: shaimaaeldesouky@dent.tanta.edu.eg
    • Principal Investigator: Shimaa Hadwa, assistant professor
    • Sub-Investigator: Nora Abo Shanady, lecturer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1: zinc oxide-pomegranate peel extract paste; 30 primary molars will be treated with pomegranate peel extract freshly mixed with zinc oxide powder till it reaches a suitable consistency (1:1 ratio by volume) to cover pulp stumps	Procedure: Pulpotomy; Teeth will be anesthetized then Rubber dam and high suction will be used in pulpotomy procedure. Cavity outline will be performed by sterile #330 high speed bur using water spray. Caries will be removed by large spoon excavator. When pulpal exposure occurred, the roof of pulp chamber will be removed by low speed round bur. Haemostasis will be obtained by applying pressure with a moist cotton pellet with saline. Then the test materials will be applied. after that, pulp stumps of all molars in each group will be dressed using Intermediate restorative material, then the tooth will be restored with a preformed stainless steel crown; Procedure: Radiation; Radiographic evaluation will be performed immediately after teeth restoration (baseline radiograph), then after three, six, and twelve months for the furcation radiolucency area and bone radiodensity. A photo-simulated phosphorus plate sensor was used to take direct standardized digital radiographs. The parallel periapical technique was obtained by Rinn, which is attached to the X-ray tube with its arm fastened to the film holder that contained a coated PSP (photo-stimulated phosphorus plate). To ensure standardization during radiographic film retakes, condensation rubber base impression material will be positioned on the outside of the film holder, and the child is told to bite on it while the material is set. The sensor wil exposed to an X-ray machine (Planmeca ProX, Helsinki, Finland) with a central ray perpendicular to the sensor at 70 kVp, 6 mA, and 0.8 s. Radio-densitometric and radiometric analysis of the radiographs will be performed by RadiAnt software.
Active Comparator: group 2: MTA; 30 primary molars will be treated with MTA to cover pulp stumps	Procedure: Pulpotomy; Teeth will be anesthetized then Rubber dam and high suction will be used in pulpotomy procedure. Cavity outline will be performed by sterile #330 high speed bur using water spray. Caries will be removed by large spoon excavator. When pulpal exposure occurred, the roof of pulp chamber will be removed by low speed round bur. Haemostasis will be obtained by applying pressure with a moist cotton pellet with saline. Then the test materials will be applied. after that, pulp stumps of all molars in each group will be dressed using Intermediate restorative material, then the tooth will be restored with a preformed stainless steel crown; Procedure: Radiation; Radiographic evaluation will be performed immediately after teeth restoration (baseline radiograph), then after three, six, and twelve months for the furcation radiolucency area and bone radiodensity. A photo-simulated phosphorus plate sensor was used to take direct standardized digital radiographs. The parallel periapical technique was obtained by Rinn, which is attached to the X-ray tube with its arm fastened to the film holder that contained a coated PSP (photo-stimulated phosphorus plate). To ensure standardization during radiographic film retakes, condensation rubber base impression material will be positioned on the outside of the film holder, and the child is told to bite on it while the material is set. The sensor wil exposed to an X-ray machine (Planmeca ProX, Helsinki, Finland) with a central ray perpendicular to the sensor at 70 kVp, 6 mA, and 0.8 s. Radio-densitometric and radiometric analysis of the radiographs will be performed by RadiAnt software.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
absence of pain	Measuring Method: Verbal Question to Patient /Parents Measuring Unite: score 0 for absence of pain and score 1 for presence of pain	up to 9 months
absence of fistula	Measuring Method: Visual examination by operator Measuring Unit: score 0 for absence of swelling and score 1 for presence of swelling	up to 9 months]
Tenderness to percussion	Measuring Method: Percussion test Measuring Unite: Binary (+/-)	up to 9 months
Furcation radiolucency	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)	3 months
furcation radiolucency	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)	6 months
furcation radiolucency	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)	9 months

Collaborators and Investigators

• Sponsor: Tanta University

Publications and helpful links

General Publications

• Farsi N, Alamoudi N, Balto K, Mushayt A. Success of mineral trioxide aggregate in pulpotomized primary molars. J Clin Pediatr Dent. 2005 Summer;29(4):307-11. doi: 10.17796/jcpd.29.4.n80t77w625118k73.
• Mushtaq A, Nangia T, Goswami M. Comparative Evaluation of the Treatment Outcomes of Pulpotomy in Primary Molars Using Mineral Trioxide Aggregate and 3Mixtatin: A Randomized Clinical Trial. Int J Clin Pediatr Dent. 2023 Nov-Dec;16(6):810-815. doi: 10.5005/jp-journals-10005-2720.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: July 31, 2025
• First Submitted That Met QC Criteria: July 31, 2025
• First Posted (Actual): August 7, 2025

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Primary molars; Pulpotomy; Mineral Trioxide Aggregate; Pomegranate Peel Extract
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Dental Pulp Diseases; Tooth Diseases; Pulpitis; Dental Pulp Exposure
• Other Study ID Numbers: #R-PED-7-25-3206

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No