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

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03580135

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulp Disease, Dental	Drug: Propolis Drug: Mineral Trioxide Aggregate	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Jan 2, 2019

Anticipated Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Propolis powder 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 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. Other Names: propolis bee resin
Active Comparator: Mineral Tri Oxide 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 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. Other Names: MTA

Arm

Intervention/Treatment

Experimental: Propolis powder

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

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.

Other Names:

propolis bee resin

Active Comparator: Mineral Tri Oxide

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

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.

Other Names:

MTA

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.