- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02780856
Safety and Performance Evaluation of the Calcivis System
Clinical Study to Evaluate the Safety and Performance of the Calcivis System for Identifying Active Demineralization on Tooth Surfaces
This is a prospective, multi-centre clinical study to evaluate the safety and performance of the Calcivis Caries Activity Imaging System. Dentists will identify tooth surfaces as either sound (inactive) or unsound (active caries lesion present) according to ICDAS staging (International Caries Detection and Assessment System). Images of the tooth surface will be taken with the Calcivis System immediately before and after application of a disclosing solution containing a bioluminescent protein. Presence or absence of elevated luminescence on the images will indicate activity / inactivity of the presence or absence of active demineralisation on the tooth surfaces.
The study will be deemed a success if there is 70% agreement and above between:
- elevated luminescence and the presence of active caries as determined by the dentists, and
- absence of luminescence and the determination of a sound tooth surface by the dentists.
연구 개요
상세 설명
Dental caries (tooth decay) is a significant clinical and public health problem. The development of caries lesions involves a net mineral loss of dental tissue, which can lead to progressive loss of tooth structure and associated pain and disease. Detecting, assessing, diagnosis and treating such lesions are core activities in dentistry. Currently the main detection and diagnosis aids are visual inspection and the used of a probe, together with X-ray images. Determination of the activity status of a lesion (how likely it is to progress) is required to assess treatment needs. Currently methods are problematic and involve the clinicians' subjective assessment and / or monitoring of lesions progression over a number of visits.
A previous clinical study on the prototype of the Calcivis System has been conducted. The results concluded that the Calcivis System was safe for use and the level of agreement between elevated luminescence and areas of expected activity was above 70% and not due to chance (NCT02098304).
This prospective, multi-centre clinical study has been designed to assess the safety and performance of the Calcivis System. The device under evaluation comprises a hand-held customized intra-oral camera which takes images of a lesion on a tooth surface immediately before and after application of a disclosing solution which contains a bioluminescent photo-protein. The photo-protein detects free calcium ions on the tooth surface and produces a light signal if the caries lesion is active.
For the clinical study, patients identified by the Investigator from those attending routine dental appointments, who meet all the inclusion and exclusion criteria will be approached to discuss their possible participation in the study. Patients will be given a Patient Information Sheet to read and time to consider their participation in the study. If they are happy to participate they will attend for two Study Visits, 7 to 14 days apart. Written informed consent will be taken before any study procedures are conducted. As children under the age of 16 are included in this study, parent / guardian consent will be taken where appropriate.
At study Visit 1, demographics, relevant medications and oral hygiene data will be collected. The dentist will carry out an oral examination and the tooth / teeth identified as per inclusion / exclusion criteria, will be cleaned with prophy paste, rinsed with tap water and a 3-in-1 air / water spray before being air dried and staged as per ICDAS coding. Reference intra-oral photographs will be taken of each tooth. The tooth / teeth surfaces will again be air dried before imaging with the Calcivis System, immediately before and after application of the disclosing solution. A maximum of one sound (unrestored, accessible, free smooth surface of a canine or incisor, away from the gingival margin with no visible caries lesion) and one unsound (erupting or erupted molar or premolar with a visible lesion deemed to be active, in a plaque stagnation area) tooth will be imaged per patient. after imaging is completed, patients rinse out with tap water. Adverse events will be collected throughout. The dentist will then share the Calcivis images of the teeth with the patient. Post imaging questionnaires will be completed by each patient at the end of Study Visit 1 and user questionnaires completed by the dental team at the end of each Study Visit 1 day.
Patients will return for (Study Visit 2), 7 to 14 days after Visit 1, when a final oral examination will take place. Any adverse events observed or volunteered by the patient will be recorded.
The study images will be independently reviewed by another dentist, for agreement between expected lesion activity / inactive teeth and the Calcivis System.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Bathgate, 영국, EH48 2SS
- Bathgate Smile Centre
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Edinburgh, 영국, EH17 8HP
- Harper, Downie and Shanks Dental Practice
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Edinburgh, 영국, EH9 1AN
- Edinburgh Periodontics
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Edinburgh
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Dalkeith, Edinburgh, 영국, EH22 2RF
- Bosco Dental Studio
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient must be 6 years or older
- Patient must have one unrestored, accessible, free smooth buccal surface on a canine or incisor, away from the gingival surface identified with no visible lesions (coded ICDAS 0) and/or
- Patient must have one unrestored, accessible, erupting or erupted molar or premolar with a visible lesion identified as (coded ICDAS 2 or 3) in a plaque stagnation area
- Patient and / or parent or guardian must be willing and able to give written informed consent
- Patient and / or parent or guardian must be willing and able to adhere to study schedule
Exclusion Criteria:
- Any patient with recent tooth bleaching (within previous two weeks of imaging with the Calcivis System)
- Any patient having on-going re-mineralization treatment including, but not limited to high concentration prescription fluoride toothpaste
- Any patient with a fixed orthodontic appliance
- Any patient currently taking part in a clinical research study, or has taken part in a clinical research study in the previous three months
- Pregnant and / or nursing mothers
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
다른: Sound and unsound teeth
Sound (ICDAS 0) canines or incisors and unsound (ICDAS 2 or 3) molars or pre-molars - imaging with the Calcivis System
|
Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and a black & white and luminescent image of each tooth taken.
The images of each tooth will be overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of Teeth Identified as Sound or Unsound by the Calcivis System That Were in Agreement With the Dentist's Assessment
기간: Day 0
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Agreement between the dentist's assessment (ICDAS staging) of sound (inactive) and unsound (active) teeth and the visible presence of elevated bioluminescence on the tooth surface using the Calcivis System
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Day 0
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Number of Non-patient Related Adverse Events of the Calcivis System
기간: Day 0 and Day 7
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Collection of all Adverse Events throughout the duration of the study
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Day 0 and Day 7
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Patient Experience
기간: Day 0
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Completion of Patient Questionnaires after imaging with the Calcivis System
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Day 0
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User Experience
기간: Day 0
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Completion of User Questionnaires after imaging with the Calcivis system
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Day 0
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Neil Shanks, BDS, MJDF, Harper, Downie and Shanks Dental Practice
- 수석 연구원: Elaine Downie, BDS, Harper, Downie and Shanks Dental Practice
- 수석 연구원: Fraser Morrison, BDS, Bathgate Smile Centre
- 수석 연구원: Steve Martin, BDS, MJDF, Edinburgh Periodontics
- 수석 연구원: Agnieszka Nohawica, BDS, Bosco Dental Studio
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 (추정)
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
- CAL-02-2014
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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. .
Imaging with the Calcivis System에 대한 임상 시험
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Stryker Orthopaedics종료됨관절 성형술, 교체, 무릎룩셈부르크, 독일, 영국