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Pomegranate Peel Extract for Primary Molar Pulpotomy

Exploring Natural Alternatives: Pomegranate Peel Extract for Primary Molar Pulpotomy

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07108738
Enrollment
30
Registered
2025-08-07
Start date
2025-08-31
Completion date
2026-04-30
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulp Exposure, Dental, Pulpitis Reversible

Keywords

Pulpotomy, Primary molars, Pomegranate Peel Extract, Mineral Trioxide Aggregate

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.

Interventions

PROCEDUREPulpotomy

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

PROCEDURERadiation

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.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
absence of painup to 9 monthsMeasuring Method: Verbal Question to Patient /Parents Measuring Unite: score 0 for absence of pain and score 1 for presence of pain
absence of fistulaup 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 percussionup to 9 monthsMeasuring Method: Percussion test Measuring Unite: Binary (+/-)
Furcation radiolucency3 monthsMeasuring 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)
furcation radiolucency6 monthsMeasuring 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)

Countries

Egypt

Contacts

Primary Contactshaimaa eldesouky, assistant professor
shaimaaeldesouky@dent.tanta.edu.eg+201008994242

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026