NCT07712627

Brief Summary

Periodontitis is a chronic inflammatory disease associated with dental plaque and characterized by the progressive destruction of the tooth-supporting tissues. The principal features of periodontitis include clinical attachment loss (CAL), alveolar bone loss, periodontal pocket formation, gingival bleeding, and the subsequent loss of periodontal tissue support. The current gold standard for the management of periodontal disease comprises oral hygiene instruction (OHI), non-surgical periodontal therapy (NSPT), periodontal surgery when indicated, and supportive periodontal therapy (SPT). In addition, various antimicrobial agents are used as adjuncts to periodontal treatment. One such agent, hypochlorous acid (HOCl), is a potent antimicrobial with high affinity against Gram-negative bacteria within the subgingival biofilm. Hypochlorous acid is commercially available in mouthwash and spray formulations, which patients may use as adjunctive therapies following periodontal treatment. In the present project, hypochlorous acid will be applied by the clinician using a dental device during periodontal treatment in a clinical setting. Changes in both clinical and biochemical outcomes, including high-sensitivity C-reactive protein (hs-CRP), C-reactive protein (CRP), antistreptolysin O (ASO), and oncostatin M (OSM), will be recorded and compared with those obtained following conventional periodontal treatment performed using purified water. The novelty of the proposed study lies in the first-time use of hypochlorous acid as an irrigant in place of purified water during scaling and root planing (SRP), with the aim of evaluating its effects on both clinical and biochemical parameters. This project is expected to attract the attention of researchers investigating the treatment of periodontitis and may facilitate publication in high-impact international peer-reviewed journals as well as presentation at prestigious scientific congresses. Furthermore, it will contribute to the training of qualified researchers in periodontology and support the completion of a doctoral dissertation. The findings may also provide preliminary data for future studies aimed at developing hypochlorous acid-based adjunctive therapeutic approaches for the management of periodontitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

June 14, 2026

Last Update Submit

July 13, 2026

Conditions

Keywords

PERİODONTİTİSCRPhs-CRPONCOSTATİN MAnti-streptolysin OHypochlorous acidNon-surgical Periodontal Therapy

Outcome Measures

Primary Outcomes (4)

  • Clinical Attachment Level (CAL)

    Assessment of clinical attachment level (CAL), measured in millimeters, as an indicator of periodontal tissue healing.

    Baseline, 1 month and 3 months

  • Probing Pocket Depth (PPD)

    Assessment of probing pocket depth (PPD), measured in millimeters, to evaluate clinical periodontal healing.

    Baseline, 1 month and 3 months

  • Plaque Index (PI)

    Assessment of dental plaque accumulation.

    Baseline, 1 month and 3 months

  • Bleeding on Probing (BOP)

    Assessment of gingival bleeding following periodontal probing.

    Baseline, 1 month and 3 months

Secondary Outcomes (4)

  • C-Reactive Protein (CRP)

    Baseline, 1 month, and 3 months

  • High-Sensitivity C-Reactive Protein (hs-CRP)

    Baseline, 1 month and 3 months

  • Oncostatin M (OSM)

    Baseline, 1 month and 3 months

  • Antistreptolysin O (ASO)

    Baseline, 1 month and 3 months

Study Arms (2)

Scaling and Root Planing (SRP) with Hypochlorous Acid

EXPERIMENTAL

Participants will undergo scaling and root planing (SRP) using hypochlorous acid.

Procedure: Hypochlorous Acid Application

Scaling and Root Planing (SRP) with Purified Water

ACTIVE COMPARATOR

Participants will undergo scaling and root planing (SRP) using an ultrasonic device with purified water.

Procedure: Scaling and Root Planing (SRP) with Purified Water

Interventions

Scaling and root planing (SRP) will be performed using an ultrasonic device with a hypochlorous acid solution.

Scaling and Root Planing (SRP) with Hypochlorous Acid

Scaling and root planing (SRP) will be performed using an ultrasonic device with purified water.

Scaling and Root Planing (SRP) with Purified Water

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals aged 18 to 65 years.
  • Systemically healthy individuals.
  • Diagnosis of Stage I or Stage II periodontitis according to the 2017 Classification of Periodontal Diseases.
  • Probing pocket depth (PPD) ≤5 mm and clinical attachment loss (CAL) ≤4 mm.
  • Presence of a sufficient number of teeth for periodontal evaluation.
  • Willingness to participate and ability to provide written informed consent.

You may not qualify if:

  • Patients with contraindications to the use of ultrasonic instrumentation.
  • Pregnant or lactating women.
  • Patients receiving anti-inflammatory or antibiotic therapy.
  • Patients with systemic diseases or medical conditions.
  • Patients receiving continuous medication for any medical condition.
  • Patients who have undergone periodontal treatment within the previous 6 months.
  • Patients presenting with acute dental pain (e.g., pulpitis or apical/periodontal abscess).
  • Individuals who smoke or consume alcohol.
  • Presence of fewer than 15 teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Atatürk University

Erzurum, Erzurum, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

PeriodontitisDry Socket

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The clinical outcome assessor will be blinded to group allocation. The clinician performing the intervention will be aware of the assigned treatment; however, participants will not be explicitly informed of their group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly allocated into two parallel groups: a test group receiving scaling and root planing (SRP) using hypochlorous acid and a control group receiving scaling and root planing (SRP) using purified water.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 14, 2026

First Posted

July 17, 2026

Study Start

October 9, 2025

Primary Completion

May 15, 2026

Study Completion

June 12, 2026

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to confidentiality and privacy considerations. As this is a single-center study involving a limited number of participants, no formal data-sharing plan has been established.

Locations