ID

23435

Descrição

Responsible Party: Geistlich Pharma AG ClinicalTrials.gov Identifier: NCT02356770 History of Changes Other Study ID Numbers: 10860 DRKS00003586 ( Registry Identifier: Deutsches Register Klinischer Studien ) CIV-11-12-003323 ( Other Identifier: EUDAMED ) Study First Received: December 18, 2014 Last Updated: February 2, 2015 A Clinical Study to Investigate Collagen Matrix 10808 for Soft Tissue Volume Augmentation Around Single Implants ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02356770

Link

https://clinicaltrials.gov/ct2/show/NCT02356770

Palavras-chave

Versões (1)
  1. 04/07/2017 04/07/2017 -
Transferido a

4 de julho de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Soft Tissue Volume Augmentation DRKS00003586 NCT02356770 DRKS00003586

Inglês

Eligibility Soft Tissue Volume Augmentation NCT02356770 DRKS00003586

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Implant placement at least 6 weeks and maximum 6 months prior enrolment
Descrição

Implants

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021102
2. Necessity of soft tissue augmentation in single tooth gap
Descrição

Soft tissue augmentation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2732454
3. 2 teeth adjacent to each side of the defect have a mean BOP (Bleeding of probing) of < 30%
Descrição

Teeth adjacent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1319068
4. Basic periodontal examination (BPE <2)
Descrição

Basic periodontal examination

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332275
UMLS CUI [1,2]
C0582103
5. 18 years or older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
6. Ability to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
Descrição

Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
7. Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form
Descrição

Understanding Ability

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0582778
UMLS CUI [2]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Descrição

Control Group

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009932
1. Heavy smoker (> 10 cigarettes per day)
Descrição

Smoking Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1519386
2. Probing depth greater than 4 mm
Descrição

Probing Depth

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1317646
3. Insulin dependent diabetes
Descrição

Insulin dependent diabetes

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
4. General contraindications for dental and/or surgical treatment
Descrição

Contraindication

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1301624
5. History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
Descrição

Prior Radiotherapy or Chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2]
C1514457
6. Women of child bearing age, not using a standard accepted method of birth control
Descrição

Contraceptive Methods

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0700589
7. Pregnancy or breast feeding
Descrição

Gynaecological Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. Previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
Descrição

Medication affecting mucosal healing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1513724
9. Disease affecting connective tissue metabolism (e.g. collagenases).
Descrição

Connective Tissue Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009782
10. Allergy to collagen
Descrição

Hypersensitivity to Collagen

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0009325
11. Participation in a clinical trial within the last six months
Descrição

Study Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
Voltar ao início da página

Similar models

Eligibility Soft Tissue Volume Augmentation NCT02356770 DRKS00003586

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Implants
Item
1. Implant placement at least 6 weeks and maximum 6 months prior enrolment
boolean
C0021102 (UMLS CUI [1])
Soft tissue augmentation
Item
2. Necessity of soft tissue augmentation in single tooth gap
boolean
C2732454 (UMLS CUI [1])
Teeth adjacent
Item
3. 2 teeth adjacent to each side of the defect have a mean BOP (Bleeding of probing) of < 30%
boolean
C1319068 (UMLS CUI [1])
Basic periodontal examination
Item
4. Basic periodontal examination (BPE <2)
boolean
C0332275 (UMLS CUI [1,1])
C0582103 (UMLS CUI [1,2])
Age
Item
5. 18 years or older
boolean
C0001779 (UMLS CUI [1])
Compliance
Item
6. Ability to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
boolean
C1321605 (UMLS CUI [1])
Understanding Ability
Item
7. Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form
boolean
C0582778 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
0. Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Smoking Status
Item
1. Heavy smoker (> 10 cigarettes per day)
boolean
C1519386 (UMLS CUI [1])
Probing Depth
Item
2. Probing depth greater than 4 mm
boolean
C1317646 (UMLS CUI [1])
Insulin dependent diabetes
Item
3. Insulin dependent diabetes
boolean
C0011854 (UMLS CUI [1])
Contraindication
Item
4. General contraindications for dental and/or surgical treatment
boolean
C1301624 (UMLS CUI [1])
Prior Radiotherapy or Chemotherapy
Item
5. History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
boolean
C0279134 (UMLS CUI [1])
C1514457 (UMLS CUI [2])
Contraceptive Methods
Item
6. Women of child bearing age, not using a standard accepted method of birth control
boolean
C0700589 (UMLS CUI [1])
Gynaecological Status
Item
7. Pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medication affecting mucosal healing
Item
8. Previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
boolean
C0013216 (UMLS CUI [1,1])
C1513724 (UMLS CUI [1,2])
Connective Tissue Diseases
Item
9. Disease affecting connective tissue metabolism (e.g. collagenases).
boolean
C0009782 (UMLS CUI [1])
Hypersensitivity to Collagen
Item
10. Allergy to collagen
boolean
C0020517 (UMLS CUI [1,1])
C0009325 (UMLS CUI [1,2])
Study Participation Status
Item
11. Participation in a clinical trial within the last six months
boolean
C2348568 (UMLS CUI [1])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial