- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05502627
To Study the Healing Effect of 0.25% Lemongrass Oil Mouthwash on Chronic Periodontitis Patients.
August 15, 2022 updated by: Ummara Komal, Postgraduate Medical Institute, Lahore
To Study the Healing Effect of 0.25% Lemongrass Oil Mouthwash on Chronic Periodontitis Patients by Evaluating the Levels of Transforming Growth Factor-beta
Periodontitis is the inflammation of the tissues supporting the teeth.
Lemongrass (Cymbopogon Citratus) oil mouthwash can be used with subgingival scaling in the treatment of periodontal diseases.
Transforming growth factor beta (TGF-β) is a multifunctional cytokine belonging to transforming growth factor superfamily and its elevated levels are detectable in inflammatory and healing process The present project will be conducted to evaluate the expression of TGF-β levels in chronic periodontitis patients after ultrasonic scaling and using 0.25% lemongrass oil mouthwash.
TGF-β is a salivary marker of periodontitis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Periodontitis is the inflammation of the tissues supporting the teeth which include cementum, gingiva, periodontal ligaments and alveolar bone.
Periodontitis typically follows untreated gingivitis, a shift in the composition of biofilm from gram positive cocci to dominantly gram negative actinomyces and infection by proteolytic obligate anaerobes resulting in progressive destruction of periodontal ligament, formation of pocket around the teeth and resorption of alveolar bone with ultimately loosening or loss of teeth.
The present project will be associated with very common forms of periodontitis (in which the inflammation results in periodontal tissue destruction and alveolar bone resorption) and gingivitis (in which the inflammation is confined to gingivae and is reversible with good oral hygiene).
Lemongrass (Cymbopogon Citratus) oil mouthwash can be used with subgingival scaling to eliminate the pathogens of periodontitis and to treat the inflammation and the damage done to periodontium by it.
It possess anti-oxidant, anti-inflammatory, anti-microbial, anti-fungal and astringent properties.
Citral epoxide which is an ingredient of lemongrass extract is an active anti-inflammatory and anti-bacterial agent.
It is useful in dentistry and has a wide role in the treatment of periodontal diseases.
Transforming growth factor beta (TGF-β) is a multifunctional cytokine belonging to transforming growth factor superfamily and its elevated levels are detectable in inflammatory and healing process The present project will be conducted to evaluate the expression of TGF-β levels in chronic periodontitis patients after ultrasonic scaling and using 0.25% lemongrass oil mouthwash.
TGF-β is a salivary marker of periodontitis.
A sample size of 30 patients either male or female aged between 40 and 60 years with chronic localized or generalized periodontitis with pocket depth of >3mm affecting at least two nonadjacent sites/teeth will be selected.
This sample will be divided into two equal groups.
In the experimental 1 group, only sub-gingival scaling will be performed.
In the experimental 2 group, sub-gingival scaling will be performed, followed by use of 0.25% lemongrass oil mouthwash twice daily for 14 days.
Saliva sample will be collected on days 0, 7 and 14 and level of salivary biomarker, TGF-β will be measured with the ELISA technique.
The data will be entered and analyzed using SPSS 22. Mean ±SD will be given for quantitative variables like TGF-β level.
A p value of ≤ 0.05 will be considered as statistically significant.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Punjab dental hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Male or female with age range between 40-60 years with generalized periodontitis were taken for the study
Description
Inclusion Criteria:
- Male or female of age between 40-60 years with generalized periodontitis
- Minimum 15 teeth should present in oral cavity
- Patient who don't have received periodontal therapy for last three months
- Probing depth > 3mm
Exclusion Criteria:
- Patient taking antibiotics or NSAIDS within last three months
- Patients with oral mucous lesions, Oral carcinoma, xerostomia, previous history of radiotherapy or chemotherapy
- Hypersensitivity to lemongrass
- Any systemic illness
- Pregnant females
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Experimental group
scaling was done along with intervention (0.25% lemongrass mouthwash was given)
|
0.25% lemon grass oil mouth wash given twice daily for fourteen days to the patients of chronic periodontitis after scaling in experimental group and in control group only scaling was done.
Other Names:
|
|
control group
only scaling was done
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To observe the healing of patients with chronic periodontitis.
Time Frame: 10 months
|
0.25% lemon grass oil effect on healing of chronic periodontitis by measuring levels of TGF-Beta.
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Asrar Ahmed, M. Phil. OB, PGMI, Lahore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Actual)
January 1, 2022
Study Completion (Actual)
April 20, 2022
Study Registration Dates
First Submitted
August 11, 2022
First Submitted That Met QC Criteria
August 15, 2022
First Posted (Actual)
August 16, 2022
Study Record Updates
Last Update Posted (Actual)
August 16, 2022
Last Update Submitted That Met QC Criteria
August 15, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PGMILahorePakistan
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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