Investigate"Clinically" the Effectiveness of Boswellia Based Intracanal Medication Compared to Calcium Hydroxide Ca(OH)2 and Ledermix on the Levels of Bacteria and Inflammatory Cytokines in Root Canals and Periradicular Tissues of Teeth With Apical Periodontitis
Effectiveness of Boswellia as Intracanal Medication on Infectious/Inflammatory Contents in Teeth With Apical Periodontitis
1 other identifier
interventional
36
1 country
1
Brief Summary
The objective of this study is to investigate "clinically" the effectiveness of Boswellia based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide Ca(OH)2 and Ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2022
1 active site
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
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 8, 2024
CompletedFirst Posted
Study publicly available on registry
June 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2024
CompletedJune 20, 2024
June 1, 2024
2.1 years
June 8, 2024
June 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Microbiological culture (manual counting to bacterial cells)
Bacterial counting after culturing of bacteria
up to 8 months
Secondary Outcomes (1)
ELISA test to measure levels of Inflammatory cytokines (tumor necrotizing factor, prostaglandin E2, Interleukin 1B)
30 weeks
Study Arms (3)
Calcium Hydroxide
ACTIVE COMPARATORintracanal medicament
Leddermix
ACTIVE COMPARATORintracanal medicament
Boswellia
ACTIVE COMPARATORintracanal medicament
Interventions
Eligibility Criteria
You may qualify if:
- Single-rooted with pulp necrosis and apical periodontitis.
- The age range from 20 to 60 years
You may not qualify if:
- Receiving antibiotic treatment within the preceding 3 months.
- Reporting systemic disease.
- Teeth that could not be isolated with rubber dam.
- Teeth with periodontal pockets deeper than 3 mm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
May Abuzoor
Al Mansurah, Egypt
Related Publications (2)
Khosravi Samani M, Mahmoodian H, Moghadamnia A, Poorsattar Bejeh Mir A, Chitsazan M. The effect of Frankincense in the treatment of moderate plaque-induced gingivitis: a double blinded randomized clinical trial. Daru. 2011;19(4):288-94.
PMID: 22615671BACKGROUNDRaja AF, Ali F, Khan IA, Shawl AS, Arora DS, Shah BA, Taneja SC. Antistaphylococcal and biofilm inhibitory activities of acetyl-11-keto-beta-boswellic acid from Boswellia serrata. BMC Microbiol. 2011 Mar 16;11:54. doi: 10.1186/1471-2180-11-54.
PMID: 21406118BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Amany Badr, Professor
Mansoura University
- STUDY DIRECTOR
Youssry RM Elhawary, Professor
Mansoura University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2024
First Posted
June 20, 2024
Study Start
June 1, 2022
Primary Completion
July 1, 2024
Study Completion
July 20, 2024
Last Updated
June 20, 2024
Record last verified: 2024-06