Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Clinical and Biochemical Evaluation of Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
The aim of the present study is to evaluate and compare the clinical and biochemical outcomes of Ozoral® and High Cure® (chlorhexidine gel) as adjuncts to non-surgical periodontal therapy in smoker patients with Stage II Grade B periodontitis, using non-smoker patients with the same diagnosis as a comparative control group.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Periodontal diseases are disease processes involving the periodontium, a term used to describe the supportive apparatus surrounding a tooth, which includes the gingival tissue, alveolar bone, cementum, and periodontal ligament.
Chlorhexidine (CHX) has been widely used in dentistry as an antiplaque and antimicrobial agent due to its broad-spectrum activity against Gram-positive and Gram-negative bacteria, fungi, and some viruses. The antimicrobial action of chlorhexidine is mainly attributed to its ability to alter bacterial cell membrane permeability, resulting in leakage of intracellular components.
Ozone (O₃) is a highly reactive oxidizing agent that has gained increasing attention in medical and dental applications because of its potent antimicrobial, anti-inflammatory, and wound-healing properties. Ozone exerts its antimicrobial effect through oxidative damage to microbial cell walls and intracellular components, leading to rapid microbial inactivation.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Sara A Agha, B.D.S
- 전화번호: 00201025536848
- 이메일: Ahmedagha55aa@gmail.com
연구 장소
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Cairo, 이집트, 12511
- 모병
- October 6 University
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부수사관:
- Osama S El-Shall, MD
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연락하다:
- Sara A Agha, B.Sc
- 전화번호: 00201025536848
- 이메일: Ahmedagha55aa@gmail.com
-
부수사관:
- Amany A Al-Araby, MD
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male and female patients aged 25-45 years
- Diagnosed with Stage II Grade B periodontitis
- Clinical attachment loss of 3-4 mm
- Radiographic bone loss confined to the coronal third of the root
- Either smokers or non-smokers
Exclusion Criteria:
- Systemic diseases affecting periodontal health
- Pregnancy or lactating female
- Periodontal therapy within the last 6 months
- Use of antibiotics or anti-inflammatory medication during the last
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Group I (control - standard of care control)
Participants will receive conventional scaling and root planing only. |
Participants will receive conventional scaling and root planing only. |
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실험적: Group II (experimental)
Participants will receive conventional scaling and root planing in addition to chlorhexidine gel application according to the manufacturer's instructions for subgingival delivery. |
Participants will receive conventional scaling and root planing in addition to chlorhexidine gel application according to the manufacturer's instructions for subgingival delivery. |
|
실험적: Group III (experimental)
Participants will receive conventional scaling and root planing in addition to ozone gel application according to the manufacturer's instructions for subgingival delivery. |
Participants will receive conventional scaling and root planing in addition to ozone gel application according to the manufacturer's instructions for subgingival delivery. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in gingival crevicular fluid tumor necrosis factor-alpha level
기간: 6 months after treatment
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Change from baseline in gingival crevicular fluid tumor necrosis factor-alpha (TNF-α) level will be measured using enzyme-linked immunosorbent assay (ELISA) at baseline, 15 days, and 6 months after treatment.. |
6 months after treatment
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in gingival crevicular fluid Interleukin-1 level
기간: 6 months after treatment
|
Change from baseline in gingival crevicular fluid Interleukin-1(IL-1) evel will be measured using enzyme-linked immunosorbent assay (ELISA) at baseline, 15 days, and 6 months after treatment.. |
6 months after treatment
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Change in Plaque Index
기간: 6 months after treatment
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Change from baseline in Plaque Index, scored from 0 (no plaque) to 3 (abundant plaque accumulation). Lower scores indicate better oral hygiene. Changes will be compared among the three treatment groups. |
6 months after treatment
|
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Change in Gingival Index
기간: 6 months after treatment
|
Change from baseline in Gingival Index, scored from 0 (normal gingiva) to 3 (severe inflammation with a tendency toward spontaneous bleeding). Lower scores indicate less gingival inflammation. Changes will be compared among the three treatment groups. |
6 months after treatment
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Change in Periodontal Probing Depth
기간: 6 months after treatment
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Change from baseline in periodontal probing depth will be measured in millimeters from the gingival margin to the base of the periodontal pocket using a periodontal probe. A reduction indicates improvement. Changes will be compared among the three treatment groups. |
6 months after treatment
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Change in Clinical Attachment Level
기간: 6 months after treatment
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Change from baseline in clinical attachment level will be measured in millimeters from the cementoenamel junction to the base of the periodontal pocket using a periodontal probe. A reduction in this distance indicates clinical attachment gain. Changes will be compared among the three treatment groups. |
6 months after treatment
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- (4) 27/4/2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD 공유 기간
After the end of study for one year.
IPD 공유 액세스 기준
The data will be available upon a reasonable request from the corresponding author.
IPD 공유 지원 정보 유형
- 연구_프로토콜
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