Supplementation With L-ornithine But Not L-arginine Increases Density of CD68+ and CD163+ Macrophages in Periodontitis

NCT05042024 | Completed Phase 3 DMC

• 1 other identifier: 0120U101151
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study was to investigate whether oral administration of L-arginine or L-ornithine could modulate local representation density and ratio of macrophages in periodontitis-affected gingiva by using immunohistochemical detection of CD68+ and CD163+ macrophages in biopsies of the gingiva. The null hypothesis tested was that L-arginine and L-ornithine have no influences on CD68+ and CD163+ macrophages densities when supplementing the treatment of periodontitis. Materials and methods. 75 individuals with a diagnosis of generalized periodontitis at stages II-III and grade B (38 women and 37 men, 51% and 49%, respectively) were included in the study. Periodontitis was diagnosed by using the criteria of the Classification of Periodontal and Peri-Implant Diseases and Conditions 2017. 25 patients received scaling and root planing only; 25 patients additionally received L-arginine, and 25 - L-ornithine, according to instructions available in Ukraine. For the immunohistochemical study of paraffin-embedded sections, the gingival biopsy was taken from 5 selected patients per group before treatment and after 1 month. CD68+ (cluster of differentiation 68 positive) and CD163+ cells served as a morphological equivalent of M1, M2 macrophages subpopulations, and their densities were calculated per 10000 μm2. Statistical analysis was performed by adequate power methods.

Conditions

Periodontitis

Keywords

L-arginine; L-ornithine; M1 M2 macrophages; macrophages-targeted therapy; periodontitis

Outcome Measures

Primary Outcomes (3)

• Periodontal pocket depth (PPD)

  Mean changes in probing depth (PD). Measurements were taken from six periodontal sites on all teeth (except for the third molars) by a single calibrated examiner using a manual periodontal probe (0106.DT06.CP10, Den Tag, Italy) to the nearest 1 mm.

  Before treatment and after 1 month ± 5 days.

• Clinical attachment level (CAL)

  Mean changes in clinical attachment level.Measurements were taken from six periodontal sites on all teeth (except for the third molars) by a single calibrated examiner using a manual periodontal probe (0106.DT06.CP10, Den Tag, Italy) to the nearest 1 mm.

  Before treatment and after 1 month ± 5 days.

• Bleeding on probing (BoP) measurements

  Mean changes in BoP

  Before treatment and after 1 month ± 5 days.

Secondary Outcomes (1)

• CD68+ and CD163+ macrophages density in gingiva

  Before treatment and after 1 month ± 5 days.

Study Arms (3)

the SRP Group

ACTIVE COMPARATOR

Patients received conventional periodontal therapy including scaling and root planing as a full-mouth procedure, n=25.

Procedure: Scaling and root planing

the Arg Group

EXPERIMENTAL

Patients received oral L-arginine aspartate (Yuria-Pharm, Ukraine) at a dose of 1 g t.i.d. for 10 days after conventional periodontal therapy, n=25.

Procedure: Scaling and root planing; Drug: Oral L-arginine aspartate administration

the Orn Group

EXPERIMENTAL

Patients received oral L-ornithine aspartate (Farmak, Ukraine) at a dose of 3 g t.i.d. for 15 days after conventional periodontal therapy, n=25.

Procedure: Scaling and root planing; Drug: Oral L-ornithine aspartate administration

Interventions

Scaling and root planing PROCEDURE

Conventional periodontal therapy, non-surgical periodontal therapy

Also known as: SRP

the Arg Group; the Orn Group; the SRP Group

Oral L-arginine aspartate administration DRUG

The use of L-arginine aspartate as adjuncts to local conservative treatment (scaling and root planing) of periodontitis to optimize treatment by modulating local macrophage subpopulations

Also known as: Oral supplementation with Tivortin® Aspartate (Yuria-Pharm, Ukraine)

the Arg Group

Oral L-ornithine aspartate administration DRUG

The use of L-ornithine aspartate as adjuncts to local conservative treatment (scaling and root planing) of periodontitis to optimize treatment by modulating local macrophage subpopulations

Also known as: Oral supplementation with Larnamin (Farmak, Ukraine)

the Orn Group

Eligibility Criteria

• Age: 25 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of periodontitis
• Good general health
• At least 19 remaining teeth
• Written informed consent forms

You may not qualify if:

• Antibiotics or anti-inflammatory medications use within the preceding 3 months
• Periodontal therapy within the previous 6 months
• Purulent exudation from periodontal pockets
• Pregnancy and breastfeeding
• Presence of severe, uncontrolled (decompensated) diseases of the internal organs, or neuropsychiatric disorders
• Presence of other conditions that determined the inability of the patient to understand the nature and possible consequences of the study

Sponsors & Collaborators

• Ukrainian Medical Stomatological Academy: lead

Study Sites (1)

Ukrainian Medical Stomatological Academy

Poltava, 36011, Ukraine

Location

Related Publications (21)

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MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing; Dietary Supplements

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Igor P Kaydashev, Dr.hab.

  Ukrainian Medical Stomatological Academy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honored Master of Science and Technology of Ukraine, Doctor of Medical Sciences, Professor Vice-Rector for Research and Development

Model Details: Patients were grouped by stratified randomization into three groups: the SRP Group (patients received conventional periodontal therapy including scaling and root planing as a full-mouth procedure, n=25); the Arg Group (patients received oral L-arginine aspartate (Yuria-Pharm, Ukraine) at a dose of 1 g t.i.d. for 10 days after conventional periodontal therapy, n=25); and the Orn Group (patients received oral L-ornithine aspartate (Farmak, Ukraine) at a dose of 3 g t.i.d. for 15 days after conventional periodontal therapy, n=25).

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 13, 2021
• Study Start: October 20, 2017
• Primary Completion: October 2, 2018
• Study Completion: November 1, 2018
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)