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

Chronic Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05502627
• Other study ID #: PGMILahorePakistan
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: April 20, 2022

Study information

• Verified date: August 2022
• Source: Postgraduate Medical Institute, Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 20, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Punjab dental hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Medical Institute, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To observe the healing of patients with chronic periodontitis.	0.25% lemon grass oil effect on healing of chronic periodontitis by measuring levels of TGF-Beta.	10 months