To Study the Healing Effect of 0.25% Lemongrass Oil Mouthwash on Chronic Periodontitis Patients.

Sponsor
Postgraduate Medical Institute, Lahore (Other)
Overall Status
Completed
CT.gov ID
NCT05502627
Collaborator
(none)
30
1
12.6
2.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.25% lemon grass oil mouthwash

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 Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
To Study the Healing Effect of 0.25% Lemongrass Oil Mouthwash on Chronic Periodontitis Patients by Evaluating the Levels of Transforming Growth Factor-beta
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Jan 1, 2022
Actual Study Completion Date :
Apr 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental group

scaling was done along with intervention (0.25% lemongrass mouthwash was given)

Drug: 0.25% lemon grass oil mouthwash
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:
  • lemon grass mouth wash
  • control group

    only scaling was done

    Outcome Measures

    Primary Outcome Measures

    1. To observe the healing of patients with chronic periodontitis. [10 months]

      0.25% lemon grass oil effect on healing of chronic periodontitis by measuring levels of TGF-Beta.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Male or female of age between 40-60 years with generalized periodontitis

    2. Minimum 15 teeth should present in oral cavity

    3. Patient who don't have received periodontal therapy for last three months

    4. Probing depth > 3mm

    Exclusion Criteria:
    1. Patient taking antibiotics or NSAIDS within last three months

    2. Patients with oral mucous lesions, Oral carcinoma, xerostomia, previous history of radiotherapy or chemotherapy

    3. Hypersensitivity to lemongrass

    4. Any systemic illness

    5. Pregnant females

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Punjab dental hospital Lahore Punjab Pakistan 54000

    Sponsors and Collaborators

    • Postgraduate Medical Institute, Lahore

    Investigators

    • Study Director: Asrar Ahmed, M. Phil. OB, PGMI, Lahore

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ummara Komal, Doctor, Postgraduate Medical Institute, Lahore
    ClinicalTrials.gov Identifier:
    NCT05502627
    Other Study ID Numbers:
    • PGMILahorePakistan
    First Posted:
    Aug 16, 2022
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 16, 2022