ID

23435

Beschreibung

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

Stichworte

Versionen (1)
  1. 04.07.17 04.07.17 -
Hochgeladen am

4. Juli 2017

DOI

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Creative Commons BY 4.0
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Eligibility Soft Tissue Volume Augmentation DRKS00003586 NCT02356770 DRKS00003586

Englisch

Eligibility Soft Tissue Volume Augmentation NCT02356770 DRKS00003586

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Implants

Datentyp

boolean

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

Soft tissue augmentation

Datentyp

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%
Beschreibung

Teeth adjacent

Datentyp

boolean

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

Basic periodontal examination

Datentyp

boolean

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

Age

Datentyp

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
Beschreibung

Compliance

Datentyp

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
Beschreibung

Understanding Ability

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Beschreibung

Control Group

Datentyp

boolean

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

Smoking Status

Datentyp

boolean

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

Probing Depth

Datentyp

boolean

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

Insulin dependent diabetes

Datentyp

boolean

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

Contraindication

Datentyp

boolean

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

Prior Radiotherapy or Chemotherapy

Datentyp

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
Beschreibung

Contraceptive Methods

Datentyp

boolean

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

Gynaecological Status

Datentyp

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)
Beschreibung

Medication affecting mucosal healing

Datentyp

boolean

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

Connective Tissue Diseases

Datentyp

boolean

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

Hypersensitivity to Collagen

Datentyp

boolean

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

Study Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Soft Tissue Volume Augmentation NCT02356770 DRKS00003586

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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