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NCT Number: NCT07108738

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.

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Key information

Conditions

Pulpitis Reversible Dental Pulp Diseases Dental Pulp Exposure Pulp Exposure, Dental Stomatognathic Diseases Tooth Diseases

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Egypt

Location contact

Nora Abo Shanady, lecturer

SUB_INVESTIGATOR

Shimaa Hadwa, assistant professor

PRINCIPAL_INVESTIGATOR

shaimaa eldesouky, assistant professor

CONTACT

[email protected]

01008994242

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulpotomy

Procedure

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

Radiation

Procedure

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.

Primary outcomes

  1. absence of pain

    Time frame: 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

  2. absence of fistula

    Time frame: 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

  3. Tenderness to percussion

    Time frame: up to 9 months

    Measuring Method: Percussion test Measuring Unite: Binary (+/-)

  4. Furcation radiolucency

    Time frame: 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)

  5. furcation radiolucency

    Time frame: 6 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)

  6. furcation radiolucency

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

shaimaa eldesouky, assistant professor

CONTACT

[email protected]

+201008994242

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Exploring Natural Alternatives: Pomegranate Peel Extract for Primary Molar Pulpotomy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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