Chronic PeriodontitisNCT05502627
To Study the Healing Effect of 0.25% Lemongrass Oil Mouthwash on Chronic Periodontitis Patients.
An observational study of Chronic Periodontitis, run by Postgraduate Medical Institute, Lahore at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- 0.25% lemon grass oil mouthwash
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2021to 20 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Male or female with age range between 40-60 years with generalized periodontitis were taken for the study
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Periodontitis
- Being tested
- 0.25% lemon grass oil mouthwash
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25% lemon grass oil mouthwashDrug
Also called lemon grass mouth wash
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | scaling was done along with intervention (0.25% lemongrass mouthwash was given) Receives: Drug: 0.25% lemon grass oil mouthwash | |
| control group | only scaling was done |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Apr 2021
- Primary completion1 Jan 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Medical Institute, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ummara Komal, Postgraduate Medical Institute, Lahore
- Investigators
- Asrar Ahmed, M. Phil. OB, Study director, PGMI, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502627
- Sponsor's protocol ID
- PGMILahorePakistan
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05502627
- Acronym / sponsor ID
- PGMILahorePakistan
- Conditions
- Chronic Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Postgraduate Medical Institute, LahoreUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Drug: 0.25% lemon grass oil mouthwashscaling was done along with intervention (0.25% lemongrass mouthwash was given) |
| control group | – | –only scaling was done |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male or female with age range between 40-60 years with generalized periodontitis were taken for the study
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.25% lemon grass oil mouthwashAlso: lemon grass mouth wash0.25% 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. | Drug | Experimental group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asrar Ahmed, M. Phil. OB study director
PGMI, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Periodontitis, run by Postgraduate Medical Institute, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To observe the healing of patients with chronic periodontitis. (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.