- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07687680
Ozone Versus Conventional Socket Disinfection for Primary Dental Implant Stability
Comparison of Ozone and Conventional Socket Disinfection in Dental Implant Placement in Terms of Primary Stability
연구 개요
상태
정황
상세 설명
Primary implant stability is a key determinant of successful osseointegration and long-term implant survival. Various implant site disinfection methods have been proposed to reduce the microbial load before implant placement. Ozone possesses antimicrobial and biostimulatory properties and may improve the biological environment for implant healing compared with conventional implant site disinfection.
The purpose of this randomized split-mouth controlled clinical trial is to compare ozone implant site disinfection with conventional implant site disinfection in terms of primary and early secondary implant stability.
Systemically healthy adults requiring at least two dental implants in symmetrical or contralateral edentulous sites will be enrolled. According to a randomized split-mouth design, one implant site will receive ozone disinfection before implant placement, whereas the paired implant site will receive conventional disinfection. This design allows each participant to serve as their own control, thereby minimizing inter-individual variability.
Primary implant stability will be assessed immediately after implant placement using insertion torque measurements and resonance frequency analysis (Implant Stability Quotient, ISQ). Secondary implant stability will be evaluated by resonance frequency analysis at the 3-month follow-up during healing abutment placement. All clinical procedures will be standardized and performed by experienced clinicians. The study aims to determine whether ozone implant site disinfection provides superior implant stability during the early osseointegration period compared with conventional implant site disinfection.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Merkez
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Adıyaman, Merkez, 터키 (Türkiye), 02030
- Faculty of Dentistry, Adıyaman University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 18 years or older.
- Systemically healthy individuals requiring at least two dental implants.
- Presence of symmetrical or contralateral edentulous sites suitable for dental implant placement.
- Adequate bone volume for implant placement without the need for simultaneous bone augmentation.
- Ability and willingness to provide written informed consent and comply with the study protocol.
Exclusion Criteria:
- Adults aged 18 years or older.
- Systemically healthy individuals requiring at least two dental implants.
- Presence of symmetrical or contralateral edentulous sites suitable for dental implant placement.
- Adequate bone volume for implant placement without the need for simultaneous bone augmentation.
- Ability and willingness to provide written informed consent and comply with the study protocol.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Ozone Disinfection
Implant sites assigned to the experimental intervention receive ozone disinfection before dental implant placement.
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Before dental implant placement, the implant site assigned to the experimental intervention is disinfected using ozone according to the study protocol.
In this randomized split-mouth design, each participant receives ozone disinfection at one implant site, while the paired contralateral or symmetrical implant site receives conventional disinfection.
Implant stability is evaluated immediately after implant placement using insertion torque and resonance frequency analysis (ISQ), and again after 3 months using ISQ.
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실험적: Conventional Disinfection
Implant sites assigned to the control intervention receive conventional implant site disinfection before dental implant placement.
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Before dental implant placement, the implant site assigned to the control intervention is disinfected using the conventional disinfection protocol.
In this randomized split-mouth design, each participant receives conventional disinfection at one implant site, while the paired contralateral or symmetrical implant site receives ozone disinfection.
Implant stability is evaluated immediately after implant placement using insertion torque and resonance frequency analysis (ISQ), and again after 3 months using ISQ.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Primary Implant Stability (Insertion Torque)
기간: Immediately after implant placement
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Primary implant stability will be assessed immediately after implant placement by measuring insertion torque (Ncm).
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Immediately after implant placement
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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
기타 연구 ID 번호
- HRU-25.18.55
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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