Postoperative Pain Evaluation of Mineral Trioxide Aggregate and Propolis After Pulpotomy in Carious Primary Molars

Study Overview
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Brief Summary
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The study will be self-funded by investigator and carried out on patients from outpatient clinic in Pediatric Dentistry and Public Health Department- Faculty of Dentistry, Cairo University- Egypt. The procedures will be carried out by postgraduate student Rawda Nader Fathy who has B.D.S. (2011) -Alexandria University- Egypt. The procedures will be carried out on a Knight Midmark Biltmore dental unit (Midmark Corporation 1700 S. Patterson Blvd. Suite 400 Dayton, Ohio 45409, USA) in the post graduate clinic of Pediatric Dentistry and Public Health Department- Faculty of Dentistry, Cairo University- Egypt.

Official Title
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Postoperative Pain Evaluation of Mineral Trioxide Aggregate and Propolis After Pulpotomy in Carious Primary Molars: A Randomized Controlled Trial

Conditions
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Pulp Disease, Dental

Intervention / Treatment
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* Drug: Propolis
* Drug: Mineral Trioxide Aggregate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cooperative patient Healthy 5-8 years old patient with at least one carious primary molar tooth at each side of the patient's mouth. Presence of at least two-thirds of the root length radiographically. Restorable tooth. No signs of hyperemia and hemostasis will be adequately achieved with moistened cotton pellet within 5 minutes after coronal pulp amputation. Exclusion Criteria: Teeth showing clinical and radiographic evidence of pulp degeneration such as history of spontaneous or nocturnal pain, tenderness to percussion or palpation, pathologic mobility, swelling or fistulous tract, periodontal ligament (PDL) space widening, internal root resorption, external root resorption, furcal radiolucency/inter- radicular bone destruction and/or periapical bone destruction. Patients eliciting history of known allergy to pollens associated with propolis. Parent or guardian refusal to participate.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propolis powder<br>resin (50%), vegetable Balsam, wax essential aromatic oils (30%) salivary secretions (10%) pollen(5%) other substances (5%) including amino acids ,ethanol vitamin A, B complex, and E, minerals, steroids ﬂavonoids. The most important pharmacologically active constituents in propolis are ﬂavonoids, which are well-known compounds which have antioxidant, anti-bacterial, antifungal, antiviral, and anti-inﬂammatory properties. Other ingredients: carob powder (free flow agent). Contains no yeast, salt, sugar, starch, milk, preservatives or colors. | Drug: Propolis<br>* One and half gram of Standardized Propolis Extract powder (Y.S. Eco Bee Farms Propolis Powder) at 100% was mixed with 1.75 mL of polyethylene glycol (Continental Chemicals, New Delhi, India) to form a thick consistency on a clean dry glass slab with a metal spatula. The paste was carried to the pulp stumps with a metal carrier and then condensed lightly to a thickness of 2 - 3 mm followed by placement of thick mix of GIC to seal the cavity and covered by st.st crown.<br>* Other names: propolis bee resin;|
| Active Comparator: Mineral Tri Oxide<br>Consists of calcium oxide and silicon dioxide.When these raw materials are blended, they produce tricalcium silicate, dicalcium silicate, tricalcium aluminate, and tetracalcium aluminoferrite. A radiopacifier (bismuth oxide) is added to the cement for dental radiological diagnosis. | Drug: Mineral Trioxide Aggregate<br>* MTA paste will be prepared as per the manufacturers' instructions to obtain a putty-like consistency. The mixture will be delivered to the pulp stumps and condensed lightly with a moistened sterile cotton pellet to ensure a thickness of 2 to 3 mm. A thick mix of glass ionomer cement (GIC) will applied over the MTA and covered by st.st crown.<br>* Other names: MTA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of postoperative pain after pulpotomy by asking patient and/or parents (binary yes or no) | Binary (yes or no) | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulpotomy, primary molars, propolis