Periodontal DiseaseNSPT-LANCT07892638
NON-SURGİCAL PERİODONTAL THERAPY WİTH L-ARGİNİNE
A study testing L-arginine 0.8% subgingival irrigation and Scaling and root planing in people with Periodontal Disease and Periodontal Diseases, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Periodontal Diseases
- What is being tested?
- L-arginine 0.8% subgingival irrigation and Scaling and root planing
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Periodontology
Alanya, Antalya, 07450
About this study
Official title: Evaluation of the Clinical, Biochemical, and Radiographic Effects of Adjunctive Local Subgingival L-Arginine Solution Application to Non-Surgical Periodontal Therapy: A Randomized Controlled Clinical Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Periodontal Disease, Periodontal Diseases
- Being tested
- L-arginine 0.8% subgingival irrigation, Saline 0.9% subgingival irrigation (placebo), Scaling and root planing
- Keywords
- periodontal disease, amino acid, l-arginine, non-surgical periodontal theraphy, gingival cervicular fluid
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arginine 0.8% subgingival irrigationDrug
Also called L-arginine solution
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)Other
Also called Sodium chloride 0.9%
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 planingProcedure or surgery
Also called Non-surgical periodontal therapy
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Saline 0.9% subgingival irrigation (placebo); Procedure: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months after treatment
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Jun 2026
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar GÜLTEKİN, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892638
- Sponsor's protocol ID
- 2026-06-01-MAP02
- Acronym
- NSPT-LA
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical, Biochemical, and Radiographic Effects of Adjunctive Local Subgingival L-Arginine Solution Application to Non-Surgical Periodontal Therapy: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07892638
- Acronym / sponsor ID
- NSPT-LA / 2026-06-01-MAP02
- Conditions
- Periodontal Disease, Periodontal Diseases
- Keywords
- periodontal disease, amino acid, l-arginine, non-surgical periodontal theraphy, gingival cervicular fluid
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSPT with L-arginine | Experimental | Drug: L-arginine 0.8% subgingival irrigation, Procedure: Scaling and root planingParticipants 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. |
| NSPT with Saline | Placebo comparator | Other: Saline 0.9% subgingival irrigation (placebo), Procedure: Scaling and root planingParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-65 years, any sex
Key exclusion criteria (8 listed)
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-arginine 0.8% subgingival irrigationAlso: L-arginine solutionSingle 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. | Drug | NSPT with L-arginine |
| Saline 0.9% subgingival irrigation (placebo)Also: Sodium chloride 0.9%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. | Other | NSPT with Saline |
| Scaling and root planingAlso: Non-surgical periodontal therapyFull-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. | Procedure or surgery | NSPT with L-arginine, NSPT with Saline |
Primary outcome
Change in Probing Pocket Depth (PPD)
Time frame: 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.
3 secondary outcomes
Change in Clinical Periodontal Parameters
Time frame: Baseline and 3 months after treatment
Change in GCF Biochemical Markers
Time frame: Baseline and 3 months after treatment
Change in Radiographic Alveolar Bone Level
Time frame: Baseline and 3 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-arginine 0.8% subgingival irrigation and Scaling and root planing in people with Periodontal Disease and Periodontal Diseases, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Probing Pocket Depth (PPD) (time frame: Baseline and 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.