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PeriodontitisPhase 4NCT05657015

Lepidium Sativum Extract Versus Simvastatin as an Adjunctive Local Delivery Agents to Non-Surgical Periodontal Therapy

A Phase 4 study testing Lepidium Sativum and Simvastatin in people with Periodontitis, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objectives of this clinical study were to: 1. Assess the influence of Lepidium sativum in situ gel versus simvastatin gel on the clinical parameters in periodontitis patients as the primary objective. 2. Read more about this study

Who is it for?
Ages 25 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Periodontitis
What is being tested?
Lepidium Sativum and Simvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
1 Sep 2021to 1 Jul 2022
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients with ages ranging from 25 to 50 years old.
  • Localized periodontitis, probing depth ≥5 mm. Less than 30% of teeth are involved.
  • Both genders.
  • Patients must be able to return for the recall visits and agreed to sign the written consent after a full explanation of the study.
  • Systemically free according to the American Society of Anesthesiologists (ASA I).

Who cannot join

  • Smokers
  • Pregnant and lactating women or oral contraceptive usage
  • Prisoners or abused individuals
  • Unwilling patients to perform oral hygiene measures of plaque control.
  • Patients with a history of allergy against any components of the two materials.
  • Previous Periodontal treatment or any use of antibiotic/anti-inflammatory drugs within the last 6 months before the initiation of the study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Dentitry, Ain Shams University

    Cairo

Other trials in Egypt

About this study

Official title: Lepidium Sativum Extract Versus Simvastatin as an Adjunctive Local Delivery Agents to Non-Surgical Periodontal Therapy: A Randomized Controlled Clinical Trial With Biochemical Analysis

The objectives of this clinical study were to:

  1. Assess the influence of Lepidium sativum in situ gel versus simvastatin gel on the clinical parameters in periodontitis patients as the primary objective.
  2. Detect the effect of locally delivered Lepidium sativum and simvastatin gels on the nuclear factor kappa B (NF-κB) level in gingival crevicular fluid as the secondary objective.
Read the detailed description

Periodontitis is a multifactorial inflammatory disease that is triggered by the accumulation of oral biofilm on the tooth surface, leading to progressive destruction of the periodontal supporting tissues including loss of clinical attachment level, alveolar bone resorption, and formation of periodontal pockets due to apical migration of junctional epithelium. It is characterized by microbially-associated, host-mediated inflammation that leads to loss of periodontal apparatus. The formation of a bacterial biofilm begins with gingival inflammation; however, the initiation and progression of periodontitis are based on microbiome dysbiotic ecological changes in response to nutrients from gingival inflammatory and tissue breakdown products. So periodontitis is defined as a chronic immuno-inflammatory disorder affecting all the tooth-supporting structures. The conventional treatment of periodontitis involves scaling and root surface debridement (RSD) which is the supra and subgingival mechanical debridement of the periodontal pockets. RSD is done either by manual instruments or by ultrasonic devices. Although it may be effective alone, it has limitations such as in the case of deep periodontal pockets, inaccessible areas, and severe status of the disease. Therefore, this treatment should be supported by adjunctive antibacterial agents to remove the residual bacteria. Antibacterial agents have been used along with mechanical debridement in the management of periodontal infection. For about the past 30 years, locally delivered, anti-infective pharmacological agents have been introduced to achieve this goal. Since the disease is confined to the periodontium, local delivery of the drug in the pocket itself is the best option. The pocket acts as a natural reservoir and provides easy access for the insertion of a medicinal device. Drug release and distribution throughout the pocket are provided by gingival crevicular fluid (GCF), which acts as the leaching medium. Also, significant drug levels can be maintained in the GCF for a prolonged duration. Local delivery drugs can overcome most of the adverse side effects of systemic agents. All these factors make intra-pocket drug delivery an ideal choice. Statins such as simvastatin (SMV) have been considered as an adjunct to non-surgical periodontal therapy. Statins were initially imported as cholesterol-reducing drugs, which is performed by hindering the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. Statins also have additional properties including; anti-inflammatory, anti-oxidant, anti-bacterial, and other pleiotropic effects such as blocking the release of pro-inflammatory mediators and matrix metalloproteinases (MMPs). Therefore, statins have been shown to promote bone formation and have proven to be effective in periodontal therapy. Nowadays, there are many researchers using plants as adjunctive therapy to the non-surgical periodontal treatment of disease because of their efficacy, safety, and therapeutic prominence. Lepidium sativum (LS) is one of the herbal products that is used daily without any regard for its benefits. It is an annual, edible herb that belongs to the family of Brassicaceae. It originated in Ethiopia and is found in many countries such as Saudi Arabia, India, and Egypt, and later in Europe. It had other names such as garden cress, halon, Hab Al-Rashad, and Thuffa. It is composed of seeds, leaves, and roots. All of its parts were important for medicinal effects. It has a peppery flavor so it can be used for homemade foods (as salads, and sandwiches), especially the leaves. The seeds can be used in many therapeutic domains as an anti-hyperglycemia, anti-hyperlipidemia, anti-diarrhea, anti-rheumatic, hepatoprotective, antioxidant, anti-inflammatory, and anti-microbial and in gastrointestinal, skin, and respiratory diseases, and some bone fractures healing. LS seeds contain many several phenols, minerals, proteins, fatty acids, vitamins, and carbohydrates. Because of its polyphenols composition, it has anti-microbial activity against several bacteria such as (P. auregenosa, S. aureus, and E. coli). The plant's antioxidative effect decreases the generation of reactive oxygen species on human cells and thus decreases the destruction of the disease. Oxygen stress plays an important role in the occurrence of many human diseases due to an increase in reactive oxygen species (ROS) production. Because of the anti-oxidant activity of the LS and cytoprotective effects, the pre-treatment with this plant can lead to inhibition of ROS generation. Tumor necrosis factor α (TNF-α), interleukin 6 and 10 (IL-6, IL-10), and nitric oxide (NO) are the pro-inflammatory mediators that play an important role in disease damage. Nuclear factor kappa B (NF-kB) also plays a role in inflammation by inducing the transcription of TNF-α on bacterial lipopolysaccharides (LPS). LPS may alter the anti-oxidative activity and enhance the production of inflammatory mediators. Therefore, the administration of LS seed extract will decrease the effectiveness of the bacteria and improve general health.

Due to the lack of studies that used LS as a therapeutic agent in periodontitis, the current study was performed to evaluate this plant's efficacy in the management of periodontitis. Furthermore, due to the pleiotropic effects of Simvastatin and Lepidium sativum, the present study was carried on to assess the influence of LS gel versus simvastatin gel as an adjunct to non-surgical periodontal therapy. Moreover, the effects of SMV and LS on the level of NF-κB in GCF were assessed.

Conditions
Periodontitis
Being tested
Lepidium Sativum, Simvastatin
Keywords
In situ gel, High Performance Thic Layer Chromatography, Local Drug Delivery
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lepidium SativumDrug

    Also called Garden cress

    2 ml of LS in situ gel at baseline

  • SimvastatinDrug

    1.2% of SMV in situ gel at baseline

Study groups in NCT05657015
Study groupRoleWhat they receive
Lepidium sativumExperimental15 participants 15 participants with localized stage II or III, and grade A periodontitis received about 2ml of locally delivered Lepidium sativum in situ gel with scaling and root surface debridement once at the beginning of the study
Receives: Drug: Lepidium Sativum
simvastatinActive comparator15 participants with localized stage II or III, and grade A periodontitis received about 1.2% of locally delivered Simvastatin in situ gel with scaling and root surface debridement once at the beginning of the study
Receives: Drug: Simvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess clinically the plaque index (PI) in periodontitis patients

    Percentage of tooth surfaces with bacterial deposits. Plaque index scores were recorded at six sites per tooth (mesiobuccal, buccal, disto-buccal, mesio-lingual, lingual, disto-lingual).The plaque index visually records the score such as 0,1,2, and 3 using the standard probe.

    Measured: Change at baseline (after 1 week from the last debridement) and after 3 months follow-up period

  2. Asses clinically the mean sulcus bleeding index (MSBI) in periodontitis patients

    Percentage of tooth surfaces with bleeding point sites on probing. Bleeding index scores were recorded at six sites (mesiobuccal, buccal, disto-buccal, mesio-lingual, lingual, disto-lingual). The scores were recorded as 0,1,2,3,4, and 5.

    Measured: Change at baseline (after 1 week from the last debridement) and after 3 months follow-up period

  3. Assess clinically the probing depth (PD) in periodontitis patients

    The distance between the margin of the gingiva and the base of the pocket was recorded at four points (mesio-facial, mid-facial, disto-facial, and mid-lingual) to the nearest millimeter using the University of Michigan O' probe with Williams' graduations in conjunction with an occlusal stent for the standardization of readings. The probe was inserted parallel to the long axis of the tooth.

    Measured: Change at baseline (after 1 week from the last debridement) and after 3 months follow-up period

  4. Assess clinically the clinical attachment level (CAL) in periodontitis patients

    The CAL was measured in millimeters from the cemento-enamel junction (CEJ) to the base of the pocket using the University of Michigan O' probe with Williams' graduations in conjunction with an occlusal stent for the standardization of readings.

    Measured: Change at baseline (after 1 week from the last debridement) and after 3 months follow-up period

Secondary outcomes (1)

  1. Detect biochemically the nuclear factor kappa B (NF-κB) level in the gingival crevicular fluid (GCF).

    Levels of NF-κB (ng/ml) in GCF samples were determined by using a commercially available means of Enzyme Linked Immuno Sorbent Assay (ELISA) according to the manufacturer's recommendations. The GCF samples were collected using perio-paper strips (Oraflow Inc., Smithtown, New York, USA). Perio-paper strips visually contaminated with blood were discarded. The samples were immediately placed into a sterile, labeled Eppendorf tube and stored at -20 ºC for subsequent assays. Each perio-paper was soaked with 200ul of phosphate buffering saline (PBS), vortexed, and centrifuged. A supernatant was used for the detection of NF-κB. The kit was provided by Bioassay Technology Laboratory (China) Cat No E7121 Hu.

    Measured: Change from baseline to 1 month, from 1 month to 3 months, and from baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2022
  2. Study start1 Sep 2021
  3. Primary completion1 May 2022
  4. Study completion1 Jul 2022

Resources

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
Model description
This study was designed to be a Randomized, Controlled, Triple-blinded, Phase (IV) clinical trial; the eligible participants were randomly allocated to one of the two comparative parallel groups; test and control group using computer-generated random tables (www.randomizer.org).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05657015
Sponsor's protocol ID
Local drug delivery
Status last verified
Dec 2022
First submitted
8 Nov 2022
Last updated
20 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Abouleish AE, Leib ML, Cohen NH. ASA provides examples to each ASA physical status class. ASA Monitor. 2015 Jun;79(6):38-49.

  • Agarwal S, Chaubey KK, Chaubey A, Agarwal V, Madan E, Agarwal MC. Clinical efficacy of subgingivally delivered simvastatin gel in chronic periodontitis patients. J Indian Soc Periodontol. 2016 Jul-Aug;20(4):409-416. doi: 10.4103/0972-124X.194270.

    PubMed 28298823

  • Arunachalam R, Rajeev V, Vedam V, Ganapathy S, Dhanavel J . -Perioceutics in the management of Periodontal Disease.‖ J Young Pharm.;9(1):8-13., 2017

  • Bansal M, Mittal N, Yadav SK, Khan G, Gupta P, Mishra B, Nath G. Periodontal thermoresponsive, mucoadhesive dual antimicrobial loaded in-situ gel for the treatment of periodontal disease: Preparation, in-vitro characterization and antimicrobial study. J Oral Biol Craniofac Res. 2018 May-Aug;8(2):126-133. doi: 10.1016/j.jobcr.2017.12.005. Epub 2017 Dec 13.

    PubMed 29892535

  • Juma Ab. The effects of Lepidium sativum seeds on fracture-induced healing in rabbits. MedGenMed. 2007 Apr 30;9(2):23.

    PubMed 17955079

  • Birkedal-Hansen H. Role of matrix metalloproteinases in human periodontal diseases. J Periodontol. 1993 May;64(5 Suppl):474-84. doi: 10.1902/jop.1993.64.5s.474.

    PubMed 8315570

  • Bostanci N, Ilgenli T, Emingil G, Afacan B, Han B, Toz H, Atilla G, Hughes FJ, Belibasakis GN. Gingival crevicular fluid levels of RANKL and OPG in periodontal diseases: implications of their relative ratio. J Clin Periodontol. 2007 May;34(5):370-6. doi: 10.1111/j.1600-051X.2007.01061.x. Epub 2007 Mar 13.

    PubMed 17355365

  • Aberg CH, Kelk P, Johansson A. Aggregatibacter actinomycetemcomitans: virulence of its leukotoxin and association with aggressive periodontitis. Virulence. 2015;6(3):188-95. doi: 10.4161/21505594.2014.982428.

    PubMed 25494963

  • Chakraborty A, Bhattacharjee A, Dasgupta P, Manna D, Chun WO. Simple Method for Standardization and Quantification of Linoleic Acid in Solanumnigrum Berries by HPTLC. Journal of Chromatography Separation Techniques. 2016;7:6.

  • Donos N, Calciolari E, Brusselaers N, Goldoni M, Bostanci N, Belibasakis GN. The adjunctive use of host modulators in non-surgical periodontal therapy. A systematic review of randomized, placebo-controlled clinical studies. J Clin Periodontol. 2020 Jul;47 Suppl 22:199-238. doi: 10.1111/jcpe.13232.

    PubMed 31834951

  • El Kilani NS, Hazzaa HH, Hemoud HES, Imam O. Clinical and Radiographic Assessment of Single or Combined Treatment with Lepidium sativum and Alendronate of Non-Surgically Treated Chronic Periodontitis in Postmenopausal Osteoporotic Women. J Int Acad Periodontol. 2019 Jan 31;21(1):20-28.

    PubMed 31522159

  • Elhennawy E, Hammad A, Bilal M. Effect of Adjunctive Use of Simvastatin Gel in Management of Periodontitis on the Crevicular Fluid Calproteins Levels. Egyptian Dental Journal. 2022 Apr 1;68(2):1455-64.

  • Euzebio Alves VT, de Andrade AK, Toaliar JM, Conde MC, Zezell DM, Cai S, Pannuti CM, De Micheli G. Clinical and microbiological evaluation of high intensity diode laser adjutant to non-surgical periodontal treatment: a 6-month clinical trial. Clin Oral Investig. 2013 Jan;17(1):87-95. doi: 10.1007/s00784-012-0703-7. Epub 2012 Mar 9.

    PubMed 22402617

  • Garala K, Joshi P, Shah M, Ramkishan A, Patel J. Formulation and evaluation of periodontal in situ gel. Int J Pharm Investig. 2013 Jan;3(1):29-41. doi: 10.4103/2230-973X.108961.

    PubMed 23799203

  • Gheorghe DN, Popescu DM, Salan A, Boldeanu MV, Ionele CM, Pitru A, Turcu-Stiolica A, Camen A, Florescu C, Rogoveanu I, Surlin P. Non-Surgical Periodontal Therapy Could Improve the Periodontal Inflammatory Status in Patients with Periodontitis and Chronic Hepatitis C. J Clin Med. 2021 Nov 13;10(22):5275. doi: 10.3390/jcm10225275.

    PubMed 34830557

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lepidium Sativum and Simvastatin in people with Periodontitis, run by Ain Shams 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 5 inclusion and 6 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 20 Dec 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. 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?

Assess clinically the plaque index (PI) in periodontitis patients (time frame: Change at baseline (after 1 week from the last debridement) and after 3 months follow-up period). The study lists 4 primary outcomes in all. 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 NCT05657015, which also lists 70 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 20 Dec 2022.

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