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

NCT05657015 | Completed Phase 4

• 1 other identifier: Local drug delivery
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this clinical study were to:

1. 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. 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.

Conditions

Periodontitis

Keywords

In situ gel; High Performance Thic Layer Chromatography; Local Drug Delivery

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (1)

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

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

Study Arms (2)

Lepidium sativum

EXPERIMENTAL

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

Drug: Lepidium Sativum

simvastatin

ACTIVE COMPARATOR

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

Drug: Simvastatin

Interventions

Lepidium Sativum DRUG

2 ml of LS in situ gel at baseline

Also known as: Garden cress

Lepidium sativum

Simvastatin DRUG

1.2% of SMV in situ gel at baseline

simvastatin

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentitry, Ain Shams University

Cairo, Egypt

Location

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  RESULT

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  RESULT

MeSH Terms

Conditions

Periodontitis

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Hala Abuelela, Professor

  Professor of Oral medicine, Periodontology, and Oral Diagnosis, Faculty of Dentistry, Ain Shams University, Egypt

  STUDY DIRECTOR

• Olfat Shaker, Professor

  Professor of Medical Biochemistry and Molecular Biology, Faculty of Medicine, Cairo university, Egypt

  STUDY DIRECTOR

• Dina Osman, Professor

  Professor of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy (Girls), Al Azhar university, Egypt

  STUDY DIRECTOR

• Suzan Sarhan, PHD

  Lecturer of Oral Medicine, Periodontology, and Oral Diagnosis, Faculty of Dentistry, Ain Shams University, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The phytochemicals were prepared by the pharmacist and coded so that the patients, researcher, and outcomes assessor were blinded to the type of intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: December 20, 2022
• Study Start: September 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

EG (1)