NCT04705714

Brief Summary

Boswellia sacra Flueck. oleoresin extract (frankincense) was traditionally used in the treatment of different diseases as respiratory, rheumatoid arthritis, and bacterial infections. Therefore, the antibacterial and antibiofilm activity of frankincense extract against Porphyromonas gingivalis periodontal pathogen clinical isolates were studied

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 3, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

January 3, 2021

Last Update Submit

July 16, 2021

Conditions

Keywords

frankincense extract,P. gingivalis ,antibacterial activity;susceptibility test of anaerobes; natural materials

Outcome Measures

Primary Outcomes (1)

  • isolation of the p. gingivalis

    Isolated bacteria will be cultured on specific media and Antimicrobial activity of the extract will be examined by disc diffusion method

    at day zero for in vitro study

Secondary Outcomes (1)

  • GC-MS analysis

    "up to 24 weeks"

Other Outcomes (3)

  • Crystal violet assay

    baseline

  • Light microscope and scanning electron microscope

    "up to 24 weeks"

  • qRT-PCR

    "up to 24 weeks"

Study Arms (1)

Frankincense Extract

EXPERIMENTAL

the anti-bacterial and antibiofilm activity of frankincense extract against Porphyromonas gingivalis clinical isolates were studied

Drug: Frankincense Extract

Interventions

The phytochemical composition of the volatile components of the extract was identified by GC-MS analysis, Crystal violet assay to test inhibition of biofilm formation by the tested isolates,Light microscope and scanning electron microscope were used to examine the biofilms and they confirmed the reduction of biofilm formation by frankincense extract

Also known as: Boswellia sacra Flueck. Oleoresin Extract
Frankincense Extract

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with grade III stage b periodontitis , patients who have the willing to participate in the study and informed consents will be taken from them

You may not qualify if:

  • patients who are under antibiotic therapy or any antimicrobial drugs
  • smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malak Mohamed Shoukheba

Tanta, 020, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Frankincense

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Resins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex Mixtures

Study Officials

  • malak m shoukheba, PHD

    faculty of dentistry tanta university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate prof.

Study Record Dates

First Submitted

January 3, 2021

First Posted

January 12, 2021

Study Start

January 15, 2021

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations