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

Phase 2

• Conditions: Pulp Disease, Dental
• Interventions: Drug: Mineral Trioxide Aggregate; Drug: Propolis

• Registration Number: NCT03580135
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-09
• Study First Submitted QC: 2018-07-06
• Study First Posted: 2018-07-09
• Study Start: 2018-11-01
• Primary Completion: 2019-01-02
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-29
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Cooperative patient
2. Healthy 5-8 years old patient with at least one carious primary molar tooth at each side of the patient's mouth.
3. Presence of at least two-thirds of the root length radiographically.
4. Restorable tooth.
5. No signs of hyperemia and hemostasis will be adequately achieved with moistened cotton pellet within 5 minutes after coronal pulp amputation.

Read More

Exclusion Criteria

1. 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.
2. Patients eliciting history of known allergy to pollens associated with propolis.
3. Parent or guardian refusal to participate.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mineral Tri Oxide	Mineral Trioxide Aggregate	* 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.
Propolis powder	Propolis	* 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.

Primary Outcome Measures

Name	Time	Method
Evaluation of postoperative pain after pulpotomy by asking patient and/or parents (binary yes or no)	9 months	Binary (yes or no)

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt