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

NCT03580135 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: Rawda N.Mahmoud
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulp Disease, Dental

Keywords

pulpotomy; primary molars; propolis

Outcome Measures

Primary Outcomes (1)

• Evaluation of postoperative pain after pulpotomy by asking patient and/or parents (binary yes or no)

  Binary (yes or no)

  9 months

Study Arms (2)

Propolis powder

EXPERIMENTAL

* 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

Mineral Tri Oxide

ACTIVE COMPARATOR

* 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

Interventions

Propolis DRUG

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.

Also known as: propolis bee resin

Propolis powder

Mineral Trioxide Aggregate DRUG

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.

Also known as: MTA

Mineral Tri Oxide

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (2)

• Alolofi H, El-Sayed M, Taha S. Clinical and radiographical evaluation of propolis and thymus vulgaris extracts compared with formocresol pulpotomy in human primary molars. BDJ Open. 2016 Jul 29;2:16005. doi: 10.1038/bdjopen.2016.5. eCollection 2016.

  PMID: 29607066 BACKGROUND

• Hugar SM, Kukreja P, Hugar SS, Gokhale N, Assudani H. Comparative Evaluation of Clinical and Radiographic Success of Formocresol, Propolis, Turmeric Gel, and Calcium Hydroxide on Pulpotomized Primary Molars: A Preliminary Study. Int J Clin Pediatr Dent. 2017 Jan-Mar;10(1):18-23. doi: 10.5005/jp-journals-10005-1400. Epub 2016 Dec 5.

  PMID: 28377649 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Propolis; mineral trioxide aggregate; Pemetrexed

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2018
• First Posted: July 9, 2018
• Study Start: November 1, 2018
• Primary Completion: January 2, 2019
• Study Completion: October 1, 2019
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

EG (1)