Propolis Versus Calcium Hydroxide on Post-Operative Pain in Patients With Necrotic Pulp
Evaluation of the Effect of Propolis Versus Calcium Hydroxide, Intracanal Medicaments on Post-Operative Pain in Patients With Necrotic Pulp (A Randomized Clinical Trial)
1 other identifier
interventional
46
0 countries
N/A
Brief Summary
Propolis is a resinous product of honeybees. Propolis is said to be effective against resistant microorganisms inside the root canal compared to the gold standard medication known as calcium hydroxide. The clinical trial tests the effect of propolis versus calcium hydroxide on pain in patients with necrotic teeth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 11, 2021
CompletedFirst Posted
Study publicly available on registry
July 30, 2021
CompletedJuly 30, 2021
July 1, 2021
2.6 years
July 11, 2021
July 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
post-operative pain
Categorical data on numerical rating scale
one week. line of 10 points
Study Arms (2)
Propolis
EXPERIMENTALintervention intracanal medicament
Calcium Hudroxide
ACTIVE COMPARATORGold standard intracanal medicament
Interventions
Eligibility Criteria
You may qualify if:
- Asymptomatic patients with age range 20 - 40 years
- Necrotic, single canal maxillary and mandibular teeth with periapical infection presented as radiolucency or widening in the periodontal membrane space.
- Medically - free of any systemic disease
- Teeth with complete root formation
You may not qualify if:
- Pregnant or lactating females
- Teeth with vital pulps, internal or external resorption or anatomic abnormalities
- Teeth with cracks, curvatures, root caries and calcified canals
- Double or triple-rooted teeth
- Patients with facial swelling, acute pulpal or periapical lesion
- Teeth that are not indicated for endodontic treatment: Bad oral hygiene, mobile or recessed
- Previously endodontically-treated teeth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
July 11, 2021
First Posted
July 30, 2021
Study Start
October 1, 2015
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
July 30, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Will be available by November 2021
- Access Criteria
- will be uploaded on google drive
the study protocol can be shared.