Pomegranate Peel Extract for Primary Molar Pulpotomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-7
SponsorTanta University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Restorable primary molars with deep carious lesions.
Absence of gingival swelling or sinus tract.
Absence of spontaneous pain
Absence of pain on percussion.
Disqualifiers
presence of spontaneous pain
presence of gingival swelling or sinus tract
presence of internal or external root resorption
pain on percussion.
Trial design
Design model
Parallel
Treatments tested in this trial
Pulpotomy
Procedure/SurgeryTeeth 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/SurgeryRadiographic 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: group 1: zinc oxide-pomegranate peel extract pasteExperimental treatment 2 interventions
Group B: group 2: MTAActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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 months2
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]3
Tenderness to percussion
Measuring Method: Percussion test Measuring Unite: Binary (+/-)
Time frame
up to 9 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov