PeriodontitisPhase 1/2MMP-8NCT04605289
Levels of Matrix Metalloproteinase-8 After Intrapocket Treatment in Moderate Periodontitis Patients.
A Phase 1/2 study testing lemongrass essential oil gel and Scaling and root planing in people with Periodontitis, run by Alexandria University at 1 site in Egypt.
Trial summary
Using local delivery drugs as adjunctive to scaling and root planing and evaluating gingival crevicular fluid (GCF) biological molecular markers (MMP-8). Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- lemongrass essential oil gel and Scaling and root planing
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jan 2020to 14 Oct 2020
- Phase
- Phase 1/2
- 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
- Patients of both sexes having moderate periodontitis (stage II), CAL 3-4mm.
- Patients' age between 25 and 45 years old.
- Systemically healthy patients.
- No history of periodontal therapy (surgical and non-surgical) or taken any antibiotic therapy for the past six months.
Who cannot join
- History of smoking.
- Patients having previous adverse reaction to the products (or similar products) used in this study.
- Grade C category that has rapid rate of progression.
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
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 Moderate Periodontitis Patients
Using local delivery drugs as adjunctive to scaling and root planing and evaluating gingival crevicular fluid (GCF) biological molecular markers (MMP-8).
Read the detailed description
Study sample and setting A sample size of twenty patients per group (number of groups = 2) (total sample size = 40 patients) is the sufficient required sample as statistically significant with 80% power. The sample size was calculated using g power version 3.1.9.2. patients will be recruited from the outpatient clinic of the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology. Faculty of Dentistry, Alexandria University.
Treatment will be in accordance with the principles of the modified Helsinki code for human clinical studies (2013).
The clinical study will be conducted following the ethical guidelines for conduct of research on human subjects, by the Faculty of Dentistry, Alexandria University (IRB NO:00010556 - IORG 0008839).
Data management and statistical analysis The data will be processed and analysed using statistical package for social sciences program SPSS (20.0) software*. The study will include descriptive and analytical data. A P-value of less than 0.05 will be considered statistically significant.
- Conditions
- Periodontitis
- Being tested
- lemongrass essential oil gel, Placebo, Scaling and root planing
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lemongrass essential oil gelDrug
Also called Cymbopogon citratus oil gel
The lemongrass oil gel will be administered by means of a syringe with a bent, blunt-end needle. The needle will be carefully inserted into the periodontal pocket and the gel will be applied in the test sites in a gentle probing manner, attempting to fill the full extent of the pocket. The gel will be applied up to the gingival margin and the excess gel will be removed with sterile gauze.
Periodontal dressing will be applied after the delivery of the drug, and they will be also asked not to eat for thirty minutes.
After placement of the gel in situ, patients will be instructed to follow strict oral hygiene protocol and not chew hard or sticky foods at the gel placement sites for rest of the week.
PlaceboDrug
Also called Carbopol®-Based pH-Sensitive gel
The placebo will be administered by means of a syringe with a bent, blunt-end needle. The needle will be carefully inserted into the periodontal pocket and the gel will be applied in the test sites in a gentle probing manner, attempting to fill the full extent of the pocket. The gel will be applied up to the gingival margin and the excess gel will be removed with sterile gauze.
Periodontal dressing will be applied after the delivery of the drug, and they will be also asked not to eat for thirty minutes.
After placement of the gel in situ, patients will be instructed to follow strict oral hygiene protocol and not chew hard or sticky foods at the gel placement sites for rest of the week.
Scaling and root planingProcedure or surgery
Conventional mechanical treatment by ultra-sonic scalers
| Study group | Role | What they receive |
|---|---|---|
| Group I (study group) | Experimental | Scaling and root planing + intra-pocket application of 2% Cymbopogon citratus (lemon-grass) gel Receives: Drug: lemongrass essential oil gel; Procedure: Scaling and root planing |
| Group II (control group) | Placebo comparator | Scaling and root planing +intra-pocket application of placebo gel Receives: Drug: Placebo; Procedure: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of clinical attachment and periodontal probing pocket
Millimeters (mm)
Measured: at baseline and twelve weeks from intervention.
Secondary outcomes (1)
GCF concentration of MMP-8
pg/ml
Measured: at baseline, one week, and twelve weeks from intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start13 Jan 2020
- Primary completion31 Aug 2020
- Study completion14 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (62)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- -Cymbopogon citratus oil gel /-Placebo gel. will be intrapocket application as an adjunctive treatment to conventional therapy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadein El Sharif, Alexandria University
- Investigators
- Nadein E Sharif, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605289
- Sponsor's protocol ID
- 17102019
- Acronym
- MMP-8
- Status last verified
- Jan 2021
- First submitted
- 15 Oct 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
Bascones-Martinez A, Munoz-Corcuera M, Noronha S, Mota P, Bascones-Ilundain C, Campo-Trapero J. Host defence mechanisms against bacterial aggression in periodontal disease: Basic mechanisms. Med Oral Patol Oral Cir Bucal. 2009 Dec 1;14(12):e680-5. doi: 10.4317/medoral.14.e680.
PubMed 19680192Preshaw M. Periodontal disease pathogenesis. 13th ed. Newman M, Takei H, Klokkevold P, Carranza F, editors. Philadelphia: Elsevier - Health Sciences Division; 2018.
Caton JG, Armitage G, Berglundh T, Chapple ILC, Jepsen S, Kornman KS, Mealey BL, Papapanou PN, Sanz M, Tonetti MS. A new classification scheme for periodontal and peri-implant diseases and conditions - Introduction and key changes from the 1999 classification. J Clin Periodontol. 2018 Jun;45 Suppl 20:S1-S8. doi: 10.1111/jcpe.12935.
PubMed 29926489Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945.
PubMed 29926495Needleman I, Garcia R, Gkranias N, Kirkwood KL, Kocher T, Iorio AD, Moreno F, Petrie A. Mean annual attachment, bone level, and tooth loss: A systematic review. J Clin Periodontol. 2018 Jun;45 Suppl 20:S112-S129. doi: 10.1111/jcpe.12943.
PubMed 29926483Taba M Jr, Kinney J, Kim AS, Giannobile WV. Diagnostic biomarkers for oral and periodontal diseases. Dent Clin North Am. 2005 Jul;49(3):551-71, vi. doi: 10.1016/j.cden.2005.03.009.
PubMed 15978241Hernández-Ríos P, Hernández M, Garrido M, Tervahartiala T, Leppilahti J, Kuula H, et al. Oral fluid matrix metalloproteinase (MMP)-8 as a diagnostic tool in chronic periodontitis. Dove Press. 2016; 2016(30):11-18.
Goodson JM. Diagnosis of Periodontitis by Physical Measurement: Interpretation From Episodic Disease Hypothesis. J Periodontol. 1992 Apr;63 Suppl 4S:373-382. doi: 10.1902/jop.1992.63.4s.373.
PubMed 29539683Griffiths GS. Formation, collection and significance of gingival crevice fluid. Periodontol 2000. 2003;31:32-42. doi: 10.1034/j.1600-0757.2003.03103.x. No abstract available.
PubMed 12656994Kinney JS, Morelli T, Braun T, Ramseier CA, Herr AE, Sugai JV, Shelburne CE, Rayburn LA, Singh AK, Giannobile WV. Saliva/pathogen biomarker signatures and periodontal disease progression. J Dent Res. 2011 Jun;90(6):752-8. doi: 10.1177/0022034511399908. Epub 2011 Mar 15.
PubMed 21406610Kinney JS, Morelli T, Oh M, Braun TM, Ramseier CA, Sugai JV, Giannobile WV. Crevicular fluid biomarkers and periodontal disease progression. J Clin Periodontol. 2014 Feb;41(2):113-120. doi: 10.1111/jcpe.12194. Epub 2013 Dec 12.
PubMed 24303954Wilton JM, Curtis MA, Gillett IR, Griffiths GS, Maiden MF, Sterne JA, Wilson DT, Johnson NW. Detection of high-risk groups and individuals for periodontal diseases: laboratory markers from analysis of saliva. J Clin Periodontol. 1989 Sep;16(8):475-83. doi: 10.1111/j.1600-051x.1989.tb02323.x.
PubMed 2674204Srivastava N, Nayak PA, Rana S. Point of Care- A Novel Approach to Periodontal Diagnosis-A Review. J Clin Diagn Res. 2017 Aug;11(8):ZE01-ZE06. doi: 10.7860/JCDR/2017/26626.10411. Epub 2017 Aug 1.
PubMed 28969294Teles RP, Haffajee AD, Socransky SS. Microbiological goals of periodontal therapy. Periodontol 2000. 2006;42:180-218. doi: 10.1111/j.1600-0757.2006.00192.x. No abstract available.
PubMed 16930311Aimetti M. Nonsurgical periodontal treatment. Int J Esthet Dent. 2014 Summer;9(2):251-67.
PubMed 24765632
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. 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 Moderate Periodontitis Patients
- ClinicalTrials.gov ID
- NCT04605289
- Acronym / sponsor ID
- MMP-8 / 17102019
- Conditions
- Periodontitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 28 Oct 2020 (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.
Using local delivery drugs as adjunctive to scaling and root planing and evaluating gingival crevicular fluid (GCF) biological molecular markers (MMP-8).
Detailed description
Study sample and setting A sample size of twenty patients per group (number of groups = 2) (total sample size = 40 patients) is the sufficient required sample as statistically significant with 80% power. The sample size was calculated using g power version 3.1.9.2. patients will be recruited from the outpatient clinic of the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology. Faculty of Dentistry, Alexandria University.
Treatment will be in accordance with the principles of the modified Helsinki code for human clinical studies (2013).
The clinical study will be conducted following the ethical guidelines for conduct of research on human subjects, by the Faculty of Dentistry, Alexandria University (IRB NO:00010556 - IORG 0008839).
Data management and statistical analysis The data will be processed and analysed using statistical package for social sciences program SPSS (20.0) software*. The study will include descriptive and analytical data. A P-value of less than 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- -Cymbopogon citratus oil gel /-Placebo gel. will be intrapocket application as an adjunctive treatment to conventional therapy
| Arm | Type | Receives |
|---|---|---|
| Group I (study group) | Experimental | Drug: lemongrass essential oil gel, Procedure: Scaling and root planingScaling and root planing + intra-pocket application of 2% Cymbopogon citratus (lemon-grass) gel |
| Group II (control group) | Placebo comparator | Drug: Placebo, Procedure: Scaling and root planingScaling and root planing +intra-pocket application of placebo gel |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients of both sexes having moderate periodontitis (stage II), CAL 3-4mm.
- Patients' age between 25 and 45 years old.
- Systemically healthy patients.
- No history of periodontal therapy (surgical and non-surgical) or taken any antibiotic therapy for the past six months.
Key exclusion criteria (4 listed)
- History of smoking.
- Patients having previous adverse reaction to the products (or similar products) used in this study.
- Grade C category that has rapid rate of progression.
- Pregnant and 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 |
|---|---|---|
| lemongrass essential oil gelAlso: Cymbopogon citratus oil gelThe lemongrass oil gel will be administered by means of a syringe with a bent, blunt-end needle. The needle will be carefully inserted into the periodontal pocket and the gel will be applied in the test sites in a gentle probing manner, attempting to fill the full extent of the pocket. The gel will be applied up to the gingival margin and the excess gel will be removed with sterile gauze. Periodontal dressing will be applied after the delivery of the drug, and they will be also asked not to eat for thirty minutes. After placement of the gel in situ, patients will be instructed to follow strict oral hygiene protocol and not chew hard or sticky foods at the gel placement sites for rest of the week. | Drug | Group I (study group) |
| PlaceboAlso: Carbopol®-Based pH-Sensitive gelThe placebo will be administered by means of a syringe with a bent, blunt-end needle. The needle will be carefully inserted into the periodontal pocket and the gel will be applied in the test sites in a gentle probing manner, attempting to fill the full extent of the pocket. The gel will be applied up to the gingival margin and the excess gel will be removed with sterile gauze. Periodontal dressing will be applied after the delivery of the drug, and they will be also asked not to eat for thirty minutes. After placement of the gel in situ, patients will be instructed to follow strict oral hygiene protocol and not chew hard or sticky foods at the gel placement sites for rest of the week. | Drug | Group II (control group) |
| Scaling and root planingConventional mechanical treatment by ultra-sonic scalers | Procedure or surgery | Group I (study group), Group II (control group) |
Primary outcome
Changes of clinical attachment and periodontal probing pocket
Time frame: at baseline and twelve weeks from intervention.
Millimeters (mm)
1 secondary outcome
GCF concentration of MMP-8
Time frame: at baseline, one week, and twelve weeks from intervention.
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 12 Jan 2021.
- Background: PubMed 19680192Bascones-Martinez A, Munoz-Corcuera M, Noronha S, Mota P, Bascones-Ilundain C, Campo-Trapero J. Host defence mechanisms against bacterial aggression in periodontal disease: Basic mechanisms. Med Oral Patol Oral Cir Bucal. 2009 Dec 1;14(12):e680-5. doi: 10.4317/medoral.14.e680.
- BackgroundPreshaw M. Periodontal disease pathogenesis. 13th ed. Newman M, Takei H, Klokkevold P, Carranza F, editors. Philadelphia: Elsevier - Health Sciences Division; 2018.
- Background: PubMed 29926489Caton JG, Armitage G, Berglundh T, Chapple ILC, Jepsen S, Kornman KS, Mealey BL, Papapanou PN, Sanz M, Tonetti MS. A new classification scheme for periodontal and peri-implant diseases and conditions - Introduction and key changes from the 1999 classification. J Clin Periodontol. 2018 Jun;45 Suppl 20:S1-S8. doi: 10.1111/jcpe.12935.
- Background: PubMed 29926495Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945.
- Background: PubMed 29926483Needleman I, Garcia R, Gkranias N, Kirkwood KL, Kocher T, Iorio AD, Moreno F, Petrie A. Mean annual attachment, bone level, and tooth loss: A systematic review. J Clin Periodontol. 2018 Jun;45 Suppl 20:S112-S129. doi: 10.1111/jcpe.12943.
- Background: PubMed 15978241Taba M Jr, Kinney J, Kim AS, Giannobile WV. Diagnostic biomarkers for oral and periodontal diseases. Dent Clin North Am. 2005 Jul;49(3):551-71, vi. doi: 10.1016/j.cden.2005.03.009.
- BackgroundHernández-Ríos P, Hernández M, Garrido M, Tervahartiala T, Leppilahti J, Kuula H, et al. Oral fluid matrix metalloproteinase (MMP)-8 as a diagnostic tool in chronic periodontitis. Dove Press. 2016; 2016(30):11-18.
- Background: PubMed 29539683Goodson JM. Diagnosis of Periodontitis by Physical Measurement: Interpretation From Episodic Disease Hypothesis. J Periodontol. 1992 Apr;63 Suppl 4S:373-382. doi: 10.1902/jop.1992.63.4s.373.
- Background: PubMed 12656994Griffiths GS. Formation, collection and significance of gingival crevice fluid. Periodontol 2000. 2003;31:32-42. doi: 10.1034/j.1600-0757.2003.03103.x. No abstract available.
- Background: PubMed 21406610Kinney JS, Morelli T, Braun T, Ramseier CA, Herr AE, Sugai JV, Shelburne CE, Rayburn LA, Singh AK, Giannobile WV. Saliva/pathogen biomarker signatures and periodontal disease progression. J Dent Res. 2011 Jun;90(6):752-8. doi: 10.1177/0022034511399908. Epub 2011 Mar 15.
- Background: PubMed 24303954Kinney JS, Morelli T, Oh M, Braun TM, Ramseier CA, Sugai JV, Giannobile WV. Crevicular fluid biomarkers and periodontal disease progression. J Clin Periodontol. 2014 Feb;41(2):113-120. doi: 10.1111/jcpe.12194. Epub 2013 Dec 12.
- Background: PubMed 2674204Wilton JM, Curtis MA, Gillett IR, Griffiths GS, Maiden MF, Sterne JA, Wilson DT, Johnson NW. Detection of high-risk groups and individuals for periodontal diseases: laboratory markers from analysis of saliva. J Clin Periodontol. 1989 Sep;16(8):475-83. doi: 10.1111/j.1600-051x.1989.tb02323.x.
- Individual participant dataSharing planned: Yes. all collected IPD
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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.
Nadein E Sharif principal investigator
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 1/2 study testing lemongrass essential oil gel and Scaling and root planing in people with Periodontitis, run by Alexandria University 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 4 inclusion and 4 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 12 Jan 2021. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes of clinical attachment and periodontal probing pocket (time frame: at baseline and twelve weeks from intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04605289, which also lists 62 linked publications.
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 12 Jan 2021.