- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07712627
Hypochlorous Acid in Non-Surgical Periodontal Therapy
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Erzurum
-
Erzurum, Erzurum, 터키 (Türkiye)
- Faculty of Dentistry, Atatürk University
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical Attachment Level (CAL)
기간: 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)
기간: 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)
기간: Baseline, 1 month and 3 months
|
Assessment of dental plaque accumulation.
|
Baseline, 1 month and 3 months
|
|
Bleeding on Probing (BOP)
기간: Baseline, 1 month and 3 months
|
Assessment of gingival bleeding following periodontal probing.
|
Baseline, 1 month and 3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
C-Reactive Protein (CRP)
기간: 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)
기간: 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)
기간: Baseline, 1 month and 3 months
|
Assessment of inflammatory cytokine levels associated with periodontal disease.
|
Baseline, 1 month and 3 months
|
|
Antistreptolysin O (ASO)
기간: 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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ATAUNI-PERIO-HOCL-2025-001
- BAP-16024 (기타 식별자: Atatürk University Scientific Research Projects Coordination Office)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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