An interventional study of L-arginine 0.8% subgingival irrigation and Saline 0.9% subgingival irrigation (placebo) in Periodontal Disease and Periodontal Diseases, sponsored by Alanya Alaaddin Keykubat University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Alanya Alaaddin Keykubat University · Not applicable, Interventional, and Treatment
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.
Periodontitis is a chronic inflammatory disease characterized by the progressive destruction of the tooth-supporting tissues, including the periodontal ligament and alveolar bone. Non-surgical periodontal therapy (NSPT), consisting primarily of scaling and root planing (SRP), is considered the gold-standard treatment for Stage I-III periodontitis. Although NSPT effectively reduces the microbial burden and improves clinical outcomes, residual inflammation and oxidative stress may persist in some patients, potentially limiting tissue healing and regeneration.
Adjunctive approaches targeting host response modulation and local periodontal wound healing have therefore gained increasing attention. Various locally delivered agents, including antiseptics, antimicrobial compounds, biologically active materials, and host-modulating therapies, have been investigated to enhance the outcomes of NSPT. However, there remains a need for safe, cost-effective, and biologically active adjunctive therapies capable of reducing inflammation and promoting periodontal tissue repair.
L-arginine is a naturally occurring amino acid involved in multiple physiological processes, including nitric oxide synthesis, immune regulation, antioxidant defense, and tissue repair. Experimental studies have demonstrated that L-arginine may reduce oxidative stress, modulate inflammatory responses, enhance fibroblast proliferation, and support osteoblastic activity. Furthermore, oral applications of arginine-containing formulations have shown beneficial effects in oral health-related conditions, including biofilm management and dentin hypersensitivity.
Recent preclinical evidence suggests that locally delivered L-arginine may contribute to periodontal tissue healing by decreasing reactive oxygen species, improving antioxidant capacity, and supporting alveolar bone regeneration. Nevertheless, clinical evidence regarding the direct subgingival application of L-arginine as an adjunct to NSPT in periodontitis patients remains limited.
The present randomized controlled clinical trial is designed to investigate whether a single local subgingival administration of L-arginine solution, delivered in conjunction with NSPT, can improve periodontal treatment outcomes. The study will evaluate the potential effects of adjunctive L-arginine therapy on clinical periodontal parameters, inflammatory and biochemical markers, and radiographic indicators of periodontal healing and bone changes.
The findings of this study may contribute to the development of novel adjunctive treatment strategies for periodontitis and provide further evidence regarding the biological and clinical effects of locally delivered L-arginine in periodontal therapy.
855 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 546 interventional studies indexed under Periodontal Diseases.
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Aged 18-65 years, any sex
Exclusion Criteria:
Pregnant or lactating women
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
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
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
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%
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
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.
Time frame: Baseline and 3 months after treatment
Change in Clinical Periodontal Parameters
Clinical attachment level (CAL, mm), Plaque Index (Silness and Löe) and Gingival Index (Löe and Silness) will be recorded at six sites per tooth.
Time frame: Baseline and 3 months after treatment
Change in GCF Biochemical Markers
Levels of IL-1β, IL-6, TNF-α, MDA, TAC, iNOS, RANKL and OPG, and the RANKL/OPG ratio, will be analyzed in gingival crevicular fluid samples collected with paper strips.
Time frame: Baseline and 3 months after treatment
Change in Radiographic Alveolar Bone Level
Distance from the cemento-enamel junction to the alveolar bone crest (mm) will be measured on standardized periapical radiographs.
Time frame: Baseline and 3 months after treatment
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Studies of the drug tested here: Arginine
Alanya Alaaddin Keykubat University