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

Pulp Disease, Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03580135
• Other study ID #: Rawda N.Mahmoud
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: October 1, 2019
• Est. primary completion date: January 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Pain, Postoperative
• Pulp Disease, Dental
• Stomatognathic Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of postoperative pain after pulpotomy by asking patient and/or parents (binary yes or no)	Binary (yes or no)	9 months