An interventional study of Pulpotomy and Radiation in Pulpitis Reversible and Pulp Exposure, Dental, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 4 Years to 7 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
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.
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.
28 studies on the registry are indexed under Dental Pulp Exposure; 5 are open to participants now.
This study's planned enrollment of 30 is below the median of 55 across 26 interventional studies indexed under Dental Pulp Exposure.
Browse Dental Pulp Exposure studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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 · Procedure: Radiation
30 primary molars will be treated with MTA to cover pulp stumps
Procedure: Pulpotomy · Procedure: Radiation
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
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.
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
Time frame: 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
Time frame: up to 9 months]
Tenderness to percussion
Measuring Method: Percussion test Measuring Unite: Binary (+/-)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 9 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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