The primary objective of the present study is: 1) To compare the amount, viability, nature and osteogenic potential of bone autograft collected with two different approaches: a) bone chips collected from the Camlog® drill flukes with aqueous…
ID
Source
Brief title
Condition
- Other condition
- Bone disorders (excl congenital and fractures)
Synonym
Health condition
(Partially) edentulous mandible or maxilla
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main objective of the present study is to explore feasibility and efficacy
of collecting autogenous bone attached to the drill flukes with and without
irrigation during implant site preparation. The primary objective of the
present study is to compare the amount, viability, nature and osteogenic
potential of bone autograft collected with two different approaches:
a) bone chips collected from the Camlog® drill flukes with aqueous irrigation
following a standard protocol;
b) bone chips collected from the Camlog® drill flukes without aqueous
irrigation following a modified slow speed drilling (speed <200 rpm).
Secondary outcome
The secondary objectives of this randomised clinical trial is to report the
clinical outcome after one year of implant placement in terms of change of
crestal bone level between surgery and 12 month post surgery and Survival and
success of implant treatment.
Background summary
Autogenous bone graft is still the gold standard in different bone grafting
procedures. Therefore, the aim of the present study is to collect autogenous
bone during implant site preparation for bone augmentation. Our Hypothesis is
"Saline irrigation might affect the amount, nature, cell viability and
osteogenic potential of the autograft collected during osteotomy preparation.
In addition avoiding saline irrigation might not affect the clinical outcome of
the implant treatment".
Study objective
The primary objective of the present study is: 1) To compare the amount,
viability, nature and osteogenic potential of bone autograft collected with two
different approaches: a) bone chips collected from the Camlog® drill flukes
with aqueous irrigation following a standard protocol; b) bone chips collected
from the Camlog® drill flukes without aqueous irrigation following a modified
slow speed drilling (speed <200 rpm). The secondary objective is: *evaluation
of the clinical success of the implants based on clinical and radiographic
findings to compare the standard drilling protocol with modified slow drilling
protocol**.
Study design
This is a split-mouth, randomized controlled clinical trial comparing the
efficacy of two treatment modalities (standard drilling protocol vs. modified
drilling protocol) in 30 patients (30 subjects/treatment). The particulate bone
graft will be collected in each patient during osteotomy preparation. The
amount, viability, nature and osteogenic potential of bone graft collected with
two different approaches will be compared using histology, scanning electron
microscopy (SEM), cell viability, and cell culture analysis. Clinical and
radiographic outcomes will be evaluated at baseline, 3 months and 1 year after
surgery.
Intervention
N/A
Study burden and risks
The surgical risks involved in the present study will not be different than
those of other conventional surgical procedures in the same region of the oral
cavity. Following are the usual risk which might be associated with placement
of implants:
* Some minor postoperative pain and discomfort will be expected for both the
control group and the test group.
* Post-operative swelling or bleeding
* Implant failure or loss
** Infection
** Loosening, loss, fracture or failure of abutment or crown
*
Early post surgical complications include lack of osseointegration and loss of
the implant. Later complications can be either biological (e.g. peri-implant
diseases) or technical complications. Every care will be taken to minimize the
ocuurence of complications. The patients however will be informed of the fact
that a strict maintenance protocol is important to detect potential
complications at an early stage.
Gustav Mahlerlaan 3004
Amsterdam The Netherlands 1081 LA
NL
Gustav Mahlerlaan 3004
Amsterdam The Netherlands 1081 LA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1: Each patient will be at least 18 years of age and able to understand and sign an informed consent.
2: All patients will be either completely edentulous or partially edentulous (single-tooth gap or an extended edentulous space).
3: All sites require to have a healing period of a minimum of 4 months subsequent to tooth extraction and capable of receiving at least a 10mm length implant (adequate bone height) without bone augmentation at the time of implant placement.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Local exclusion criteria:
Local exclusion factors include:
1: Untreated Periodontitis
2: The presence of osseous lesions, and/or unresolved extraction wounds.
3: Inadequate bone at the time of surgery resulting in a need for guided bone regeneration.
4: Severe bruxism or clenching habits.
5: Lack of motivation or compliance.
6: History of local irradiation therapy;Systemic exclusion criteria:
Systemic exclusion criteria included:
1: Bleeding disorders
2: Radiation and/or chemotherapy
3: History of renal failure
4: Bone or endocrine disorders
5: Physical handicaps capable of interfering with oral hygiene maintenance.
6: Moderate and heavy smokers (>10 cigarettes per day) or chewing tobacco.
7: Routine use of steroids
8: Leukocyte dysfunction
Secondary Exclusion Criteria:
At the time of implant placement and abutment connection, if any of the following criteria are met, a protocol deviation form should be completed and the subject should be followed for the duration of the study:;1: Subjects who require GBR treatment at implant surgery;2: Insufficient bone or any other bone abnormality that would contraindicate placement;3: The treatment required by this protocol is found to be inappropriate
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42946.029.13 |