Lepidium Sativum Extract Versus Simvastatin as an Adjunctive Local Delivery Agents to Non-Surgical Periodontal Therapy
NCT ID: NCT05657015
Last Updated: 2022-12-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-09-01
Study Completion Date
2022-07-01
Brief Summary
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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.
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.
Detailed Description
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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.
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
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Periodontitis
Keywords
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In situ gel
High Performance Thic Layer Chromatography
Local Drug Delivery
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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).
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
The phytochemicals were prepared by the pharmacist and coded so that the patients, researcher, and outcomes assessor were blinded to the type of intervention.
Study Groups
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Lepidium sativum
15 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
Group Type
EXPERIMENTAL
Lepidium Sativum
Intervention Type
DRUG
2 ml of LS in situ gel at baseline
simvastatin
15 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
Group Type
ACTIVE_COMPARATOR
Simvastatin
Intervention Type
DRUG
1.2% of SMV in situ gel at baseline
Interventions
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Lepidium Sativum
2 ml of LS in situ gel at baseline
Intervention Type
DRUG
Simvastatin
1.2% of SMV in situ gel at baseline
Intervention Type
DRUG
Other Intervention Names
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Garden cress
Eligibility Criteria
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Inclusion Criteria
* 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).
* 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).
Exclusion Criteria
* 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.
* 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.
Minimum Eligible Age
25 Years
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Ain Shams University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Hala Abuelela, Professor
Role: STUDY_DIRECTOR
Professor of Oral medicine, Periodontology, and Oral Diagnosis, Faculty of Dentistry, Ain Shams University, Egypt
Olfat Shaker, Professor
Role: STUDY_DIRECTOR
Professor of Medical Biochemistry and Molecular Biology, Faculty of Medicine, Cairo university, Egypt
Dina Osman, Professor
Role: STUDY_DIRECTOR
Professor of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy (Girls), Al Azhar university, Egypt
Suzan Sarhan, PHD
Role: STUDY_DIRECTOR
Lecturer of Oral Medicine, Periodontology, and Oral Diagnosis, Faculty of Dentistry, Ain Shams University, Egypt
Locations
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Faculty of Dentitry, Ain Shams University
Cairo, , Egypt
Site Status
Countries
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Egypt
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1.Abdelghany AM, El-Damrawi G, Oraby AH, Madshal MA. Optical and FTIR structural studies on CoO-doped strontium phosphate glasses. Journal of Non-Crystalline Solids. 2018 Nov 1;499:153-8.
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2.Abdel-Hameed HS, El-Saeed SM, Ahmed NS, Nassar AM, El-Kafrawy AF, Hashem AI. Chemical transformation of Jojoba oil and Soybean oil and study of their uses as bio-lubricants. Industrial Crops and Products. 2022 Nov 1;187:115256.
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RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Local drug delivery
Identifier Type: -
Identifier Source: org_study_id