Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure
Gingival Margin Stability After Mucogingival Plastic Surgery. The Effect of Manual Versus Powered Toothbrushing: a Randomized Clinical Trial
연구 개요
상세 설명
BACKGROUND Oscillating-rotating power toothbrushes have been proven clinically efficacious. To the investigators' knowledge, a clinical evaluation of the safety of these toothbrushes after surgical root coverage procedure have not been published. The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes.
METHODS Sixty healthy patients with at least a single Miller Class I or II gingival recession underwent surgical root coverage procedure. Soft-bristle manual and powered toothbrushes were given to participants randomly assigned to control and test group, respectively. Full-mouth plaque score, Full-mouth Bleeding Score, Probing Pocket Depth and Recession Depth were recorded 1, 3 and 6 months after completion of surgical procedure. Longitudinal analyses were performed using linear random-intercept models to take into account within-subject correlations over time. Temporal trend differences across treatments by including treatment-time interaction terms were then tested using a global Wald test.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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MI
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Milan, MI, 이탈리아, 20122
- Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Full-Mouth Plaque Score (FMPS) ≤25%
- Full-Mouth Bleeding Score (FMBS) ≤25%
- Miller Class I and II buccal recession ≥2 mm
Exclusion Criteria:
- Relevant systemic condition or disease
- Smokers
- Teeth with prosthetic crowns or restorations in the cervical area
- Presence of pulling frenum in the keratinized tissue
- Previous mucogingival or periodontal surgery in the experimental site
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Manual Toothbrush
Patients were instructed in the Roll Brushing Technique, twice daily for 2 min.
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Gum Delicate Post-Surgical Toothbrush, Oral-B, Procter & Gamble, Cincinnati, OH
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실험적: Oscillating-rotating toothbrush
Patients received manufacturer's instructions for use, including brushing twice daily for 2 min.
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Triumph 5000, Oral-B, Procter & Gamble, Cincinnati, OH
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Complete Root Coverage Rate
기간: Change in Complete Root Coverage Rate at 1 month
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Abscence of exposed root surface measured ad percentage
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Change in Complete Root Coverage Rate at 1 month
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Change in Complete Root Coverage Rate
기간: Change in Complete Root Coverage Rate at 3 months
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Abscence of exposed root surface measured ad percentage
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Change in Complete Root Coverage Rate at 3 months
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Change in Complete Root Coverage Rate
기간: Change in Complete Root Coverage Rate at 6 months
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Abscence of exposed root surface measured ad percentage
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Change in Complete Root Coverage Rate at 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Recession Depth
기간: Baseline, 1 month, 3 months, 6 months
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Distance from the gingival margin to the cementum-enamel junction, measured in millimeters
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Baseline, 1 month, 3 months, 6 months
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Change in Clinical Attachment Level
기간: Baseline, 1 month, 3 months, 6 months
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Distance from the cementum-enamel junction to the bottom of the periodontal Pocket, measured in millimeters
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Baseline, 1 month, 3 months, 6 months
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Change in Probing Pocket Depth
기간: Baseline, 1 month, 3 months, 6 months
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Distance from the gingival margin to the bottom of the periodontal pocket, measured in millimeters
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Baseline, 1 month, 3 months, 6 months
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공동 작업자 및 조사자
수사관
- 연구 책임자: Giulio Rasperini, Unit of Periodontology, Department of Biomedical, Surgical and Dental Sciences, University of Milan, Foundation IRCCS Ca' Granda Policlinic
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Manual Toothbrush에 대한 임상 시험
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Istanbul Medeniyet University모병