- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Bathgate, Reino Unido, EH48 2SS
- Bathgate Smile Centre
-
Edinburgh, Reino Unido, EH17 8HP
- Harper, Downie and Shanks Dental Practice
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Edinburgh, Reino Unido, EH9 1AN
- Edinburgh Periodontics
-
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Edinburgh
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Dalkeith, Edinburgh, Reino Unido, EH22 2RF
- Bosco Dental Studio
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Outro: 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)
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of Teeth Identified as Sound or Unsound by the Calcivis System That Were in Agreement With the Dentist's Assessment
Prazo: Day 0
|
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
|
Day 0
|
Number of Non-patient Related Adverse Events of the Calcivis System
Prazo: Day 0 and Day 7
|
Collection of all Adverse Events throughout the duration of the study
|
Day 0 and Day 7
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Patient Experience
Prazo: Day 0
|
Completion of Patient Questionnaires after imaging with the Calcivis System
|
Day 0
|
User Experience
Prazo: Day 0
|
Completion of User Questionnaires after imaging with the Calcivis system
|
Day 0
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Neil Shanks, BDS, MJDF, Harper, Downie and Shanks Dental Practice
- Investigador principal: Elaine Downie, BDS, Harper, Downie and Shanks Dental Practice
- Investigador principal: Fraser Morrison, BDS, Bathgate Smile Centre
- Investigador principal: Steve Martin, BDS, MJDF, Edinburgh Periodontics
- Investigador principal: Agnieszka Nohawica, BDS, Bosco Dental Studio
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CAL-02-2014
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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