NCT05502627

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

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

Study Start

First participant enrolled

April 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

9 months

First QC Date

August 11, 2022

Last Update Submit

August 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Experimental group

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

Drug: 0.25% lemon grass oil mouthwash

control group

only scaling was done

Interventions

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.

Also known as: lemon grass mouth wash
Experimental group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Male or female with age range between 40-60 years with generalized periodontitis were taken for the study

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Punjab dental hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Asrar Ahmed, M. Phil. OB

    PGMI, Lahore

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 16, 2022

Study Start

April 1, 2021

Primary Completion

January 1, 2022

Study Completion

April 20, 2022

Last Updated

August 16, 2022

Record last verified: 2022-08

Locations