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Hypochlorous Acid in Non-Surgical Periodontal Therapy

2026年7月13日 更新者:Alparslan Dilsiz、Ataturk University

The Effect of Hypochlorous Acid in the Non-Surgical Treatment of Stage I and Stage II Periodontitis

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.

調査の概要

詳細な説明

Periodontitis is a chronic inflammatory disease that may ultimately lead to tooth loss as a consequence of bacterial-induced destruction of the periodontal tissues. It is characterized by an inflammatory response to dental plaque within the periodontal connective tissue and alveolar bone, and the nature and magnitude of this host response largely determine disease progression. Scaling and root planing (SRP) is considered the gold standard for the treatment of periodontitis. The cornerstone of non-surgical periodontal therapy is the mechanical removal of microbial biofilm and calculus through SRP. However, SRP alone may not be sufficient to eliminate pathogenic bacteria, as these microorganisms can persist within the gingival tissues and in anatomical areas that are difficult to access using conventional periodontal instrumentation, including deep periodontal pockets, furcation involvements, interproximal areas, and root concavities. Therefore, local or systemic antimicrobial agents and antiseptics have been recommended as adjunctive therapies to improve periodontal treatment outcomes.

Owing to its antimicrobial, anti-inflammatory, and wound-healing properties, hypochlorous acid is currently used in various dental applications, including biofilm eradication, mouth rinses, wound care, endodontic irrigation, root surface conditioning, and the treatment of peri-implantitis.

This study has been designed as a single-center, randomized, controlled, prospective clinical trial to be conducted at the Department of Periodontology, Faculty of Dentistry, Atatürk University. A total of 44 systemically healthy individuals aged 18-65 years diagnosed with Stage I or Stage II periodontitis will be enrolled in the study.

Participants will be randomly allocated into two groups using a coin-toss randomization method:

Test group: Scaling and root planing (SRP) performed using hypochlorous acid. Control group: Scaling and root planing (SRP) performed using purified water.

All participants will receive standardized oral hygiene instructions at baseline. SRP will be performed using an ultrasonic device, with hypochlorous acid as the irrigating solution in the test group and purified water in the control group.

Clinical periodontal parameters will be recorded at baseline and at the 1-month and 3-month follow-up visits. These parameters will include:

Plaque Index (PI) Probing Pocket Depth (PPD) Bleeding on Probing (BOP) Clinical Attachment Level (CAL)

At the same time points, blood and saliva samples will be collected for the analysis of C-reactive protein (CRP), high-sensitivity C-reactive protein (hs-CRP), oncostatin M (OSM), and antistreptolysin O (ASO) using enzyme-linked immunosorbent assay (ELISA).

The primary objective of this study is to evaluate the clinical efficacy of hypochlorous acid as an adjunct to scaling and root planing. The secondary objective is to investigate its effects on systemic inflammatory biomarkers.

The findings of this study are expected to contribute to the current understanding of adjunctive therapeutic strategies in periodontal treatment and to support the clinical application of hypochlorous acid as a practical and effective adjunctive approach in the management of periodontitis.

研究の種類

介入

入学 (実際)

44

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Erzurum
      • Erzurum、Erzurum、トルコ(Türkiye)
        • Faculty of Dentistry, Atatürk University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

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

Exclusion Criteria:

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Scaling and Root Planing (SRP) with Hypochlorous Acid
Participants will undergo scaling and root planing (SRP) using hypochlorous acid.
Scaling and root planing (SRP) will be performed using an ultrasonic device with a hypochlorous acid solution.
アクティブコンパレータ:Scaling and Root Planing (SRP) with Purified Water
Participants will undergo scaling and root planing (SRP) using an ultrasonic device with purified water.
Scaling and root planing (SRP) will be performed using an ultrasonic device with purified water.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Clinical Attachment Level (CAL)
時間枠:Baseline, 1 month and 3 months
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)
時間枠:Baseline, 1 month and 3 months
Assessment of probing pocket depth (PPD), measured in millimeters, to evaluate clinical periodontal healing.
Baseline, 1 month and 3 months
Plaque Index (PI)
時間枠:Baseline, 1 month and 3 months
Assessment of dental plaque accumulation.
Baseline, 1 month and 3 months
Bleeding on Probing (BOP)
時間枠:Baseline, 1 month and 3 months
Assessment of gingival bleeding following periodontal probing.
Baseline, 1 month and 3 months

二次結果の測定

結果測定
メジャーの説明
時間枠
C-Reactive Protein (CRP)
時間枠:Baseline, 1 month, and 3 months
Assessment of the systemic inflammatory response by measuring serum C-reactive protein (CRP) levels.
Baseline, 1 month, and 3 months
High-Sensitivity C-Reactive Protein (hs-CRP)
時間枠:Baseline, 1 month and 3 months
Assessment of low-grade systemic inflammation by measuring high-sensitivity C-reactive protein (hs-CRP) levels.
Baseline, 1 month and 3 months
Oncostatin M (OSM)
時間枠:Baseline, 1 month and 3 months
Assessment of inflammatory cytokine levels associated with periodontal disease.
Baseline, 1 month and 3 months
Antistreptolysin O (ASO)
時間枠:Baseline, 1 month and 3 months
Assessment of the systemic immune response associated with streptococcal exposure by measuring antistreptolysin O (ASO) levels.
Baseline, 1 month and 3 months

協力者と研究者

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年10月9日

一次修了 (実際)

2026年5月15日

研究の完了 (実際)

2026年6月12日

試験登録日

最初に提出

2026年6月14日

QC基準を満たした最初の提出物

2026年7月13日

最初の投稿 (実際)

2026年7月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月17日

QC基準を満たした最後の更新が送信されました

2026年7月13日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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