Back to resultsPropolis Versus Calcium Hydroxide on Post-Operative Pain in Patients With Necrotic Pulp
Primary Purpose
Post-Operative Pain, Chronic, Necrotic Pulp
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
propolis
Calcium Hydroxide
Sponsored by
About this trial
This is an interventional diagnostic trial for Post-Operative Pain, Chronic focused on measuring calcium hydroxide, propolis, post-operative pain, necrotic pulp
Eligibility Criteria
Inclusion Criteria:
• 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
Exclusion Criteria:
• 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Propolis
Calcium Hudroxide
Arm Description
intervention intracanal medicament
Gold standard intracanal medicament
Outcomes
Primary Outcome Measures
post-operative pain
Categorical data on numerical rating scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04983524
Brief Title
Propolis Versus Calcium Hydroxide on Post-Operative Pain in Patients With Necrotic Pulp
Official Title
Evaluation of the Effect of Propolis Versus Calcium Hydroxide, Intracanal Medicaments on Post-Operative Pain in Patients With Necrotic Pulp (A Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
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
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Propolis is an immunomodulatory, antioxidant, flavonoid-rich resinous product of honeybees. Propolis was reported as less cytotoxic and more effective against resistant microorganisms than calcium hydroxide as well as biocompatible to the periradicular tissues than existing intracanal medicaments. The aim of this single-blinded randomized clinical trial was to evaluate the effect of propolis versus calcium hydroxide, intracanal medicaments, on post-operative pain in patients with necrotic single canal teeth. Methods: Forty-six participants with an age range of 20-40 years old, diagnosed as having necrotic pulp in their single-rooted, single canal teeth were included in this study, with 23 participants in each group. Treatment was done in two visits and intracanal medicament was applied for one week in between. Participants were instructed to rate their pain score by a numerical rating scale after 24, 48, 72 hours and at 7 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Pain, Chronic, Necrotic Pulp
Keywords
calcium hydroxide, propolis, post-operative pain, necrotic pulp
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propolis
Arm Type
Experimental
Arm Description
intervention intracanal medicament
Arm Title
Calcium Hudroxide
Arm Type
Active Comparator
Arm Description
Gold standard intracanal medicament
Intervention Type
Dietary Supplement
Intervention Name(s)
propolis
Intervention Description
resinous product of honeybees
Intervention Type
Drug
Intervention Name(s)
Calcium Hydroxide
Intervention Description
Gold standard control intracanal medicament
Primary Outcome Measure Information:
Title
post-operative pain
Description
Categorical data on numerical rating scale
Time Frame
one week. line of 10 points
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• 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
Exclusion Criteria:
• 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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
the study protocol can be shared.
IPD Sharing Time Frame
Will be available by November 2021
IPD Sharing Access Criteria
will be uploaded on google drive
Learn more about this trial
Propolis Versus Calcium Hydroxide on Post-Operative Pain in Patients With Necrotic Pulp
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