General Notes
40 patients are included in the study, 20 patients in group 1 (=closure with composite
material shaper; test group) and 20 patients in group 2 (=closure with custom-made
zirconia oxide abutment; control group).
Randomisation envelopes will be used for randomisation. Device under study: Straumann
BLX, Roxolid® , SLActive® dental implants with a diameter of 3.5, 3.75, 4, 4.5 mm are
used.
Allogenic bone botiss maxgraft® cortical granules are used as graft material.
Inclusion criteria:
Males and females at least 18 years of age or older.
One implant per patient.
Prior to any study-related activity, the subject must voluntarily sign informed
consent, be willing and able to attend scheduled follow-up visits, and agree to the
collection and analysis of pseudonymised data.
Lateral individual teeth (premolars and molars).
Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall).
The gingival contour of the tooth to be extracted - without recession.
Adjacent anterior teeth have no periodontal loss.
There are no implants in the adjacent teeth.
Non-traumatic tooth extraction, which results in intact walls of the socket.
Exclusion criteria:
Deep occlusion (severe, class II).
The patient smokes a lot (more than 10 cigarettes per day).
Systemic disease (osteoporosis).
No initial stability has been achieved after the implant insertion procedure. 4.2.
Surgical Procedures and Recovery Phase (see Annexes No. 1 and 2)
Group 1. Immediate implant placement and temporary closure of tapered implants with a
custom-made composite shaper after tooth extraction with bone augmentation by using
allogeneic bone.
Non-traumatic extraction.
Palatal position of tapered implant for premolars and centred position for molars
(more commonly - in the septum) 3-4 mm below the buccal gum line or 1-2 mm below the
bony protuberance.
For premolars, the implant is placed palatally 2-3 mm to the buccal bone wall, for
molars 2-3 mm to the buccal and lingual wall.
Implant insertion.
"Jump distance" sealing with allogeneic bone.
Temporary closure with a composite shaper.
Cone beam computed tomography with Carestream machine.
Taking a photo.
Scan with 3Shape TRIOS4 scanner.
After 3 months, a cone beam computed tomography is performed to evaluate changes in the
crestal bone, the temporary restoration is screwed off and the presence/absence of
bleeding is recorded. A digital impression is taken for a zirconium oxide crown made on
Ti base and to assess soft tissue changes.
The change in the buccal vertical bone level will be measured as the difference between
the former and the new vertical distance from implant platform to the buccal alveolar
crest.
While the change in the buccal horizontal bone dimension will be measured as the
difference between the former and the new horizontal distance between the implant and the
outer surface of the buccal plate. Both measurements will be taken using CBCT, one
immediately after the surgery and the other one 3 month later.
Intraoral scans with 3Shape Trios4 dental scanner will be taken to compare soft tissue
stability. Measurements will be taken before, immediately after the surgery and 3 month
later. By using STL files it will be possible to compare soft tissue stability.
Group 2. Immediate implant placement and temporary closure of tapered implant with a
custom-made zirconium oxide abutment after tooth extraction with bone augmentation by
using allogeneic bone.
Non-traumatic extraction.
Palatal position of tapered implant for premolars and centred position for molars
(more commonly - in the septum) 3-4 mm below the buccal gum line or 1-2 mm below the
bony protuberance.
For premolars, the implant is placed palatally 2-3 mm to the buccal bone wall, for
molars 2-3 mm to the buccal and lingual wall.
Implant insertion.
"Jump distance" sealing with allogeneic bone.
Closure with a zirconium oxide abutment.
Cone beam computed tomography with Carestream machine.
Taking a photo.
Scan with 3Shape TRIOS4 scanner.
After 3 months, a cone beam computed tomography is performed to evaluate changes in the
crestal bone, the custom-made abutment is screwed off and the presence/absence of
bleeding is recorded. A digital impression is taken for a zirconium oxide crown and to
assess soft tissue changes.
The change in the buccal vertical bone level will be measured as the difference between
the former and the new vertical distance from implant platform to the buccal alveolar
crest.
While the change in the buccal horizontal bone dimension will be measured as the
difference between the former and the new horizontal distance between the implant and the
outer surface of the buccal plate. Both measurements will be taken using CBCT, one
immediately after the surgery and the other one 3 month later.
Intraoral scans with 3Shape Trios4 dental scanner will be taken to compare soft tissue
stability. Measurements will be taken before, immediately after the surgery and 3 month
later. By using STL files it will be possible to compare soft tissue stability.
Evaluation Phase
T1 (Basic): After the performance of final restoration: X-ray, photograph, scan, PD, BOP,
RI.
T2: Follow-up after 3 months: X-ray, photograph, scan, PD, BOP, RI. T3: Follow-up after a
year: X-ray, photograph, scan, PD, BOP, RI.