Tutodent® Chips and Form CLINICAL EVALUATION - 3GO

INSTRUCTIONS
botiss dental GmbH, Glinkastrasse 32, D-10117 Berlin
CONTACT Dr. Drazen Tadic, Phone +49 30 2060739830, Fax +49 30 2060739820, Email drazen.tadic@botiss.com
REPORTING CLINICIAN
Please complete this form as fully as possible and utilize a separate
form for each of your graft patients. To ensure patient privacy, we
Date:
request that you only provide the patient’s initials. The confidential
information that you provide in this data collection form may be utilized
to write a retrospective, multi-center study of botiss dental. If it is,
Name:
Please Print Name & Degree As You Want It to Appear in the Article
you will first be contacted and listed as one of the co-authors of the
article, unless you decline to participate. Please return the completed
form via mail or fax to the attention of Dr. Drazen Tadic at the
Email Address:
address above.
NOTE: Report all complications and failures on page 4.
Telephone No.: ( )
Area Code
A. PATIENT DATA
Patient’s Initials: Age:
Gender: Male Female
Race: European
Other
Health Risk Factors (Check any that apply):
Controlled diabetes
Immunocompromised condition:
HIV+/AIDS
Other:
Smoker
Metabolic disorder:
Collagen disease:
Other clinical concerns:
Specify
Specify
Specify
Specify
B. DIAGNOSIS & TREATMENT PLAN
1. Type of Osseous Defect (Check the appropriate boxes):
Resorbed Ridge Dehiscence Fenestration
Resorbed Sinus Floor
2. Osseous Defect Location
(Check all that apply & circle on chart):
Buccal/facial Defect
Lingual/palatal Defect
Sinus Floor
Implant Location
Tooth Location
Edentulous Ridge Location
3. Preoperative Defect Size or Residual Sinus Floor Height
(Check all appropriate boxes):
1 mm or less 1 mm to 2 mm 2 mm to 3 mm
3 mm to 4 mm 4 mm to 5 mm 5 mm or more
4. Treatment Plan (Check all appropriate boxes):
Graft Only Graft with delayed implant placement
Graft with simultaneous implant placement
Sinus Lift/Crestal Approach
Sinus Lift/Lateral Window Approach

1. Date of graft placement:
2. Type of soft tissue flap (Check the appropriate box):
Full-thickness crestal or vestibular flap
Split palatal flap Rotated split palatal flap
Palatal sliding strip flap
Simplified papilla preservation flap
Other:
Specify
3. What particle size Cerabone did you use for this case?
0,5-1,0 mm 1,0-2,0 mm
4. When did you prepare the receptor site for the graft?
Prior to rehydration After rehydration
5. Did you add other graft material to Cerabone?
No Yes (Specify the additional graft material below):
Autogenous particulate maxgraft
maxresorb
Other:
Specify
6. What did you use for rehydration? (Specify all that apply)
Blood Sterile saline
Antibiotic:
Specify Substance & Dosage
7. Did you have problems with graft preparation?
No Yes:
Specify
8. Did you degranulate the recipient bone prior to graft
placement?
Yes
No
9. Did you use a barrier membrane in this case? (Specify)
Jason Fleece Jason Membrane
Other:
Specify
2
10. Did you use biologics in this case? (Specify all that apply)
Platelet-Rich Plasma (PRP) Technology
Emdogain
PRF or PRGF
Other:
Specify
11. Did you achieve primary closure?
Yes No
12. How did you close the surgical site? (Specify all that apply)
3-0 sutures 4-0 sutures Other:
Periodontal dressing
13. Comments on Cerabone Preparation & Placement:
D.Tutodent HEALING PHASE
1. Was antibiotic prophylaxis prescribed?
No Yes:
Specify
2. Were chlorhexidine digluconate rinses prescribed?
No Yes:
3. Was healing eventful?
No Yes:
E. Tutodent EXPOSURE
1. Date of graft exposure:
Specify percentage and dosage
Explain
2. Was the graft successfully incorporated and stable?
Yes No

3. Was any resorption of the graft observed? (Specify)
No
Quantity
Slight graft resorption: mm
Quantity
Moderate graft resorption: mm
Quantity
Severe graft resorption: mm
Quantity
Other:
4. Comments on graft exposure:
Specify
Note: If implants were not placed in this case,
please proceed to: J. LAST CLINICAL FOLLOW-UP
F. IMPLANT PLACEMENT (STAGE 1)
1. Date of implant placement:
2a. Implants Placed in the Grafted Site (Specify type & quantity)
Implant
Quantity Quantity
Quantity Quantity
Quantity Quantity
Other:
Quantity Specify Type & Quantity
2b. Implants Placed in Non-Grafted Sites (Specify type & quantity)
Quantity Quantity
Quantity Quantity
Quantity Quantity
Other:
Quantity Specify Type & Quantity
3. Implant surface(s) (Specify type and quantity placed)
MTX x HA x Other:
Quantity Quantity Specify Type & Quantity
4. Implant diameter(s) (mm) (Specify diameter and quantity placed)
3.25 x 3.3 x 3.7 mm x
Quantity Quantity Quantity
3.75 x 4.0 x 4.7 mm x
Quantity Quantity Quantity
5.0 x 6.0 x Other:
Quantity Quantity Specify Type & Quantity
5. Was the implant submerged submucosally at placement?
Yes No
3
6. Comments on implant placement:
G. IMPLANT HEALING PHASE
1. Was antibiotic prophylaxis prescribed?
No Yes:
Specify
2. Were chlorhexidine digluconate rinses prescribed?
No Yes:
3. Was healing eventful?
No Yes:
H. IMPLANT EXPOSURE (STAGE 2)
1. Date of implant exposure:
Specify percentage and dosage
Explain
2. Was the implant successfully osseointegrated?
Yes No Please report failures on page 4.
3. Comments on Implant Exposure:
I. IMPLANT RESTORATION
1. Date of prosthesis delivery:
2. Prosthesis type (Specify material and prosthesis)
Ceramometal Gold Acrylic
Single tooth Fixed partial denture
Other:
Specify Material & Prosthesis
J. LAST CLINICAL FOLLOW-UP
1. Date of follow-up:
2. What was the clinical status of the graft? (Specify)
Incorporated and functional
Other:
Specify

3. Gingival Index (Attach additional sheets for multiple implants )
Not recorded
0 Normal gingiva 1 Mild inflammation
2 Moderate inflammation 3 Severe inlfammation
4. Plaque Index (Attach additional sheets for multiple implants )
Not recorded
0 No plaque in gingival area 1 Mild plaque
2 Moderate plaque 3 Severe plaque
5. What was the clinical status of the implant? (Specify)
Osseointegrated and functional
Other:
6. Was any resorption evident radiographically? (Specify)
Cerabone resorption mm
Quantity
Periimplant crestal bone resorption x mm
Quantity
Other:
Specify
7. Periimplant Probing Depths (Attach more sheets for multiple implants )
Not recorded
0-0.5 mm
0-5-1.0 mm
1.9-1.5 mm
1.5-2.0 mm
2.0-2.5 mm
2.5-3.0 mm
> 3.0 mm
8. Comments on Clinical Follow-Up:
Mesial Distal Buccal Lingual
4
K. COMPLICATIONS AND FAILURES
1. Infection Resolved by Antibiotics
Specify Antibiotic and Dosage Used
Involvement: Graft Implant Both
2. Bone Loss Resolved by Guided Tissue Regeneration
Treatment: GTR with membrane Graft material
Involvement:
Cause:
Both Other:
Specify
Cerabone Implant
3. Failure of Cerabone and or Implant
Involvement:
4. Prosthetic Complications
Uncontrolled infection
Trauma Other:
Both
Severe bone loss
Specify
Cerabone Implant Both
Cause: Loose screw Component fracture
Other:
Specify
Involvement: Cerabone Implant Both
5. Comments on Complications and Failures