Role of Propolis Paste in Preventing Pain After Root Canal Treatment.

NCT ID: NCT03723980

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-16
• Study Completion Date: 2018-10-15

Brief Summary

This study evaluates the role of propolis paste as compared to calcium hydroxide (when used as intracanal medication) in prevention and treatment of pain after root canal treatment in necrotic (infected) teeth. Half of the participants will receive calcium hydroxide, while the other half will receive propolis.

Detailed Description

Propolis is a developing herbal medicament used in various aspects on dentistry. it is extremely biocompatible; has flavanoids; which acts as anti-inflammatory and antimicrobial components.

Calcium hydroxide is a synthetic medication which is antibacterial

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control Group or Group I or Calcium hydroxide Group

Group Type: ACTIVE_COMPARATOR

Calcium Hydroxide

Intervention Type: DRUG

it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days.

Experimental Group or Group II or Propolis Group

Group Type: EXPERIMENTAL

Propolis

Intervention Type: DRUG

it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days.

Interventions

Propolis

it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days.

Intervention Type: DRUG

Calcium Hydroxide

it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days.

Intervention Type: DRUG

Other Intervention Names

Bee glue

Eligibility Criteria

Inclusion Criteria

• Single rooted Necrotic teeth with symptomatic or asymptomatic periapical periodontitis having periapical widening or radiolucency without bone expansion (PAI index 2, 3 and 4).
• Teeth with favorable root morphology.
• Teeth with closed apex.

Exclusion Criteria

• Teeth with PAI index 1 and 5.
• Patients who are on antibiotics.
• Patient with recent trauma to the jaw.
• Teeth with open apex
• Multi-rooted teeth.
• Vital teeth.
• Non-restorable teeth.
• Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or obliterated).
• Teeth associated with soft tissue abscess or swelling.
• Teeth with external or internal root resorption
• Re-treatment cases.
• Periodontally compromised teeth (like mobile teeth and teeth with excessive bone loss).
• Teeth requiring endodontic surgery.
• Teeth requiring non-surgical endodontic treatment of multiple teeth in the same or opposing quadrant.
• Medically compromised patients (ASA-III and above), patients with special communication needs or who doesn't understand Urdu or English language.
• Patients allergic to bee pollen or honey products.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: collaborator

Juzer Shabbir Saifee

OTHER

Sponsor Role: lead

Responsible Party

Juzer Shabbir Saifee

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Juzer S Saifee

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Fazal R Qazi

Role: STUDY_DIRECTOR

Dow University of Health Sciences

Locations

Dow International Dental College

Karachi, Sindh, Pakistan

Countries

Pakistan

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

ISRCTN66816132

Identifier Type: REGISTRY

Identifier Source: secondary_id

MDSJUZER

Identifier Type: -

Identifier Source: org_study_id