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

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ClinicalTrials.gov Identifier: NCT03580135
Recruitment Status : Unknown
Verified July 2019 by Rawda Nader Mahmoud, Cairo University.
Recruitment status was:  Active, not recruiting
First Posted : July 9, 2018
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Rawda Nader Mahmoud, Cairo University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : November 1, 2018
Actual Primary Completion Date : January 2, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arms and Interventions
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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 Name: 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 Name: MTA


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of postoperative pain after pulpotomy by asking patient and/or parents (binary yes or no) [ Time Frame: 9 months ]
    Binary (yes or no)


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580135


Locations
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Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
More Information
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Publications:

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Responsible Party: Rawda Nader Mahmoud, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03580135    
Other Study ID Numbers: Rawda N.Mahmoud
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: data will be available within 9 months completion of study
Access Criteria: data Access will be reviewed by external independent review panel
URL: http://register.clinicaltrials.gov

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rawda Nader Mahmoud, Cairo University:
pulpotomy
primary molars
propolis
Additional relevant MeSH terms:
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Stomatognathic Diseases
Dental Pulp Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
 Pain
Neurologic Manifestations
Tooth Diseases
Propolis
Anti-Infective Agents