NON-SURGİCAL PERİODONTAL THERAPY WİTH L-ARGİNİNE

NCT07892638 | Active Not Recruiting

• 1 other identifier: 2026-06-01-MAP02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate whether a single local application of L-arginine - a naturally occurring amino acid - into the gum pocket, in addition to standard treatment, can improve healing outcomes in patients with gum disease (periodontitis). The study is being conducted at the Faculty of Dentistry of Alanya Alaaddin Keykubat University and has received ethical approval from the Antalya Provincial Health Directorate Ethics Committee. Periodontitis is a chronic inflammatory disease in which the tissues and bone supporting the teeth are gradually damaged by bacteria. If left untreated, it can lead to tooth loss. The current standard treatment involves deep cleaning of the tooth root surfaces to reduce the bacterial load. This study tests whether adding an L-arginine solution to this treatment provides additional benefit, as laboratory and animal studies have shown that L-arginine has anti-inflammatory, antioxidant, and bone-regeneration-supporting effects. Sixty volunteers aged 18-65, diagnosed with Stage III periodontitis and who have not received any periodontal treatment in the past six months, will be enrolled. Participants will be randomly assigned to one of two groups: one group will receive L-arginine solution and the other will receive saline solution (placebo) applied into the gum pocket. Gum pocket depth, inflammatory markers, and bone levels will be assessed at baseline and at 3 months after treatment. The total follow-up period for each participant will be 3 months. Participation is entirely voluntary; participants have the right to withdraw from the study at any time. No serious risks are anticipated, and all personal information will be kept strictly confidential.

Conditions

Periodontal Disease; Periodontal Diseases

Keywords

periodontal disease; amino acid; l-arginine; non-surgical periodontal theraphy; gingival cervicular fluid

Outcome Measures

Primary Outcomes (1)

• Change in Probing Pocket Depth (PPD)

  Probing pocket depth will be measured at six sites per tooth with a manual periodontal probe (mm) and compared between baseline and 3 months after treatment.

  Baseline and 3 months after treatment

Secondary Outcomes (3)

• Change in Clinical Periodontal Parameters

  Baseline and 3 months after treatment

• Change in GCF Biochemical Markers

  Baseline and 3 months after treatment

• Change in Radiographic Alveolar Bone Level

  Baseline and 3 months after treatment

Study Arms (2)

NSPT with L-arginine

EXPERIMENTAL

Participants with Stage III periodontitis will receive full-mouth non-surgical periodontal therapy (scaling and root planing) followed by a single subgingival application of L-arginine solution (0.1-0.5 cc) into the periodontal pockets of the selected test sites using a blunt-tipped syringe. Clinical, biochemical and radiographic parameters will be assessed at baseline and 3 months after treatment.

Drug: L-arginine 0.8% subgingival irrigation; Procedure: Scaling and root planing

NSPT with Saline

PLACEBO COMPARATOR

Participants with Stage III periodontitis will receive full-mouth non-surgical periodontal therapy (scaling and root planing) followed by a single subgingival application of sterile saline solution (0.9% NaCl, 0.1-0.5 cc) into the periodontal pockets of the selected test sites using a blunt-tipped syringe, identical in appearance and application to the test solution. Clinical, biochemical and radiographic parameters will be assessed at baseline and 3 months after treatment.

Other: Saline 0.9% subgingival irrigation (placebo); Procedure: Scaling and root planing

Interventions

L-arginine 0.8% subgingival irrigation DRUG

Single subgingival irrigation with 0.1-0.5 mL of 0.8% (w/v) L-arginine solution prepared in 0.9% NaCl (pH adjusted to 7.0, sterilized by 0.22 µm filtration), applied with a blunt-tipped syringe into the periodontal pockets of the test sites immediately after SRP in the same session. Solutions are supplied in coded syringes to maintain double blinding.

Also known as: L-arginine solution

NSPT with L-arginine

Saline 0.9% subgingival irrigation (placebo) OTHER

Single subgingival irrigation with 0.1-0.5 mL of sterile 0.9% NaCl solution, applied with a blunt-tipped syringe into the periodontal pockets of the test sites immediately after SRP in the same session. The placebo is identical in appearance and delivery to the test solution and is supplied in coded syringes.

Also known as: Sodium chloride 0.9%

NSPT with Saline

Scaling and root planing PROCEDURE

Full-mouth non-surgical periodontal therapy consisting of supragingival and subgingival debridement with hand and ultrasonic instruments, performed in a single session in all participants prior to subgingival irrigation.

Also known as: Non-surgical periodontal therapy

NSPT with L-arginine; NSPT with Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65 years, any sex
• Systemically healthy individuals with no uncontrolled systemic disease
• Diagnosis of Stage III periodontitis according to the 2017 AAP/EFP classification, with clinical attachment loss (CAL) ≥ 5 mm and probing pocket depth (PPD) ≥ 6 mm
• No periodontal treatment within the past 6 months
• Willingness to participate in clinical and radiographic examinations, to complete the study, and to provide written informed consent

You may not qualify if:

• Pregnant or lactating women
• Systemic diseases such as diabetes mellitus, immune system disorders or blood disorders
• Periodontal or dental surgical treatment within the past 6 months
• History of allergic reactions, particularly to L-arginine
• Use of antibiotics, corticosteroids or immunosuppressive medications
• Active oral infection or oral tumors
• Patients receiving osteoporosis treatment or medications that reduce estrogen production (e.g., for breast cancer), patients with bilateral salpingo-oophorectomy, and patients with cancer
• Individuals considered unlikely to comply with the treatment or complete the study

Sponsors & Collaborators

• Alanya Alaaddin Keykubat University: lead

Study Sites (1)

Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Periodontology

Alanya, Antalya, 07450, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Arginine; Sodium Chloride; Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESEARCH ASSİSTANT

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 15, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

TU (1)