NON-SURGİCAL PERİODONTAL THERAPY WİTH L-ARGİNİNE

Condition(s) studied

Investigational drug(s) / intervention(s)

L-arginine 0.8% subgingival irrigation: 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.

Saline 0.9% subgingival irrigation (placebo): 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.

Scaling and root planing: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Probing Pocket Depth (PPD) — Baseline and 3 months after treatment
  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.

Trial sites (1)

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