Back to results

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

Primary Purpose

Pulp Disease, Dental

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Propolis

Mineral Trioxide Aggregate

About this trial

This is an interventional treatment trial for Pulp Disease, Dental focused on measuring pulpotomy, primary molars, propolis

Eligibility Criteria

5 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Propolis powder

Mineral Tri Oxide

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Binary (yes or no)

Secondary Outcome Measures

Full Information

NCT ID

NCT03580135

First Posted

June 9, 2018

Last Updated

July 25, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03580135

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2018 (Actual)

Primary Completion Date

January 2, 2019 (Actual)

Study Completion Date

October 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulp Disease, Dental

Keywords

pulpotomy, primary molars, propolis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Propolis powder

Arm Type

Experimental

Arm Description

Arm Title

Mineral Tri Oxide

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Propolis

Other Intervention Name(s)

propolis bee resin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Mineral Trioxide Aggregate

Other Intervention Name(s)

MTA

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Binary (yes or no)

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Cairo University

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

data will be available within 9 months completion of study

IPD Sharing Access Criteria

data Access will be reviewed by external independent review panel

IPD Sharing URL

http://register.clinicaltrials.gov

Citations:

PubMed Identifier

29607066

Citation

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.

Results Reference

background

PubMed Identifier

28377649

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs