Periodontitis Chronic Generalized ModeratePhase 4NCT05241509
Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis
A Phase 4 study testing Cymbopogon citratus (lemongrass) oil gel in people with Periodontitis Chronic Generalized Moderate, run by Souzy Kamal at 1 site in Egypt.
Trial summary
Background: Phytotherapeutics is widely used nowadays as an adjunct to scaling and root planing (SRP) to modulate inflammatory host response and eradicate microbes. Matrix metalloproteinase-8 (MMP-8) is associated with the onset of inflammation and considered an indicative biomarker to the severity of inflammatory… Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Periodontitis Chronic Generalized Moderate
- What is being tested?
- Cymbopogon citratus (lemongrass) oil gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jul 2019to 4 Dec 2021
- Phase
- Phase 4
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- systemically healthy individuals of both sexes having moderate periodontitis (stage II), CAL 3-4mm, with an age ranging from 25 to 45 years old.
- patients with no history of previous periodontal therapy or taken any antibiotic therapy for the past six months
Who cannot join
- history of smoking, previous adverse reaction to the products (or similar products) used in this study, grade C category that has rapid rate of progression, and pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Egypt1 site
department of periodontology. Faculty of dentistry. Alexandria University
Alexandria, 21521
About this study
Official title: Biochemical Efficacy of Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis: A Randomized Controlled Clinical Trial
Background: Phytotherapeutics is widely used nowadays as an adjunct to scaling and root planing (SRP) to modulate inflammatory host response and eradicate microbes. Matrix metalloproteinase-8 (MMP-8) is associated with the onset of inflammation and considered an indicative biomarker to the severity of inflammatory response. Since MMP-8 can be used as a predictive biomarker for treatment response; our research aimed to investigate clinically the effectiveness of intra-pocket application of Cymbopogon citratus (lemongrass oil) gel and biochemically on MMP-8 levels in gingival crevicular fluid (GCF) of stage II periodontitis patients.
Methods: A randomized controlled clinical trial was conducted on forty patients with stage II periodontitis, divided equally into two groups. Group-I (test) was managed by SRP with intra-pocket application of 2% lemongrass oil gel. Group-II (control) was managed by SRP with intra-pocket application of a placebo gel. Periodontal pocket depth (PPD) and clinical attachment loss (CAL) were measured for both groups, before treatment and twelve weeks after. Moreover, GCF was collected from both groups at baseline, one week, and twelve weeks after treatment. Then analysed by Enzyme-linked Assay (ELISA) technique.
- Being tested
- Cymbopogon citratus (lemongrass) oil gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cymbopogon citratus (lemongrass) oil gelDrug
Biochemical Efficacy of Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis
| Study group | Role | What they receive |
|---|---|---|
| Group I (test) | Experimental | included twenty patients treated with SRP and intrapocket application of 2% lemongrass oil gel. Receives: Drug: Cymbopogon citratus (lemongrass) oil gel |
| Group II (control) | Placebo comparator | included twenty treated with SRP and intrapocket application of placebo gel. Receives: Drug: Cymbopogon citratus (lemongrass) oil gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in periodontal pocket depth
the distance between the gingival margin and depth of probing
Measured: baseline and after 12 weeks
Change in clinical attachment loss
the distance between the CEJ and depth of probing
Measured: baseline and after 12 weeks
Change in Matrix metalloproteinase-8 level
Human Matrix metalloproteinase-8 level intracrevicularlly by collection of crevicular fluid sample
Measured: baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start6 Jul 2019
- Primary completion14 Dec 2020
- Study completion4 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis Chronic Generalized ModerateStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Souzy Kamal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Souzy Kamal, Alexandria University
- Investigators
- Souzy K. Anwar, Ph.D, Principal investigator, periodontology department. Faculty of dentistry. Alexandria university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241509
- Sponsor's protocol ID
- Lemon grass oil
- Status last verified
- Feb 2022
- First submitted
- 27 Jan 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Efficacy of Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05241509
- Acronym / sponsor ID
- Lemon grass oil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Souzy KamalUniversity, hospital or other
- Study start
- 6 Jul 2019 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 4 Dec 2021 (actual)
- First posted
- 15 Feb 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.
Background: Phytotherapeutics is widely used nowadays as an adjunct to scaling and root planing (SRP) to modulate inflammatory host response and eradicate microbes. Matrix metalloproteinase-8 (MMP-8) is associated with the onset of inflammation and considered an indicative biomarker to the severity of inflammatory response. Since MMP-8 can be used as a predictive biomarker for treatment response; our research aimed to investigate clinically the effectiveness of intra-pocket application of Cymbopogon citratus (lemongrass oil) gel and biochemically on MMP-8 levels in gingival crevicular fluid (GCF) of stage II periodontitis patients.
Methods: A randomized controlled clinical trial was conducted on forty patients with stage II periodontitis, divided equally into two groups. Group-I (test) was managed by SRP with intra-pocket application of 2% lemongrass oil gel. Group-II (control) was managed by SRP with intra-pocket application of a placebo gel. Periodontal pocket depth (PPD) and clinical attachment loss (CAL) were measured for both groups, before treatment and twelve weeks after. Moreover, GCF was collected from both groups at baseline, one week, and twelve weeks after treatment. Then analysed by Enzyme-linked Assay (ELISA) technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (test) | Experimental | Drug: Cymbopogon citratus (lemongrass) oil gelincluded twenty patients treated with SRP and intrapocket application of 2% lemongrass oil gel. |
| Group II (control) | Placebo comparator | Drug: Cymbopogon citratus (lemongrass) oil gelincluded twenty treated with SRP and intrapocket application of placebo gel. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- systemically healthy individuals of both sexes having moderate periodontitis (stage II), CAL 3-4mm, with an age ranging from 25 to 45 years old.
- patients with no history of previous periodontal therapy or taken any antibiotic therapy for the past six months
Key exclusion criteria (1 listed)
- history of smoking, previous adverse reaction to the products (or similar products) used in this study, grade C category that has rapid rate of progression, and pregnant or lactating women
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 |
|---|---|---|
| Cymbopogon citratus (lemongrass) oil gelBiochemical Efficacy of Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis | Drug | Group I (test), Group II (control) |
Primary outcome
Change in periodontal pocket depth
Time frame: baseline and after 12 weeks
the distance between the gingival margin and depth of probing
Change in clinical attachment loss
Time frame: baseline and after 12 weeks
the distance between the CEJ and depth of probing
Change in Matrix metalloproteinase-8 level
Time frame: baseline and after 12 weeks
Human Matrix metalloproteinase-8 level intracrevicularlly by collection of crevicular fluid sample
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 15 Feb 2022.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Periodontitis Chronic Generalized Moderate
RecruitingPhase 2
3-Month Clinical Trial of Liquid S-PRF in Periodontal Debridement for Periodontitis Stages II-IV
Periodontitis Stage II, Periodontitis Stage III
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.
Souzy K. Anwar, Ph.D principal investigator
periodontology department. Faculty of dentistry. Alexandria university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cymbopogon citratus (lemongrass) oil gel in people with Periodontitis Chronic Generalized Moderate, run by Souzy Kamal at 1 site in Egypt.
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 2 inclusion and 1 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 15 Feb 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in periodontal pocket depth (time frame: baseline and after 12 weeks). The study lists 3 primary outcomes in all. 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 15 Feb 2022.