Can small buccal bony dehiscences (< 4 mm) of non-submerged dental implants, seen at initial placement, be successfully reconstructed using the guided bone regeneration (GBR) technique with a mixture of Straumann bone ceramic and locally…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
level of the marginal bone around the implant
Secondary outcome
1.the plaque index (PI),
2.the bleeding index BI,
3.the gingiva index (GI),
4.the pocket probing depth (PPD), and
5.the width of the attached mucosa (WAM)
6. Peri-implant esthetic score (PES) reflects the following five items: mesial
papilla, distal papilla, curvature of the facial mucosa, level of the facial
mucosa, and root convexity/soft tissue color and texture at the facial aspect
of the implant site.
7 White esthetic score (WES) is based on the five following items: general
tooth form; outline and volume of the clinical crown; color, which includes the
assessment of the dimension*s hue and value; surface texture; and translucency
and characterization
Background summary
Patients who participate in this study need an implant supported crown for
replacing a single missing incisor, cuspid or bicuspid in the maxilla. Patients
of the first two groups have an alveolar crest which is just to small to
facilitate a full bony coverage of the implant. The bony defect seen at implant
placement can be reconstructed using a mixture of Straumann bone ceramic and
autogenous bone. This mixture is in the first group covered with a resorbable
membrane, Membragel (group A) and in the second group not covered with
Membragel (group B). Patients of the third group (group C) do not need a
reconstruction since sufficient bone is available for implant placement to make
sure that the surface of the implants is fully covered with bone.
Study objective
Can small buccal bony dehiscences (< 4 mm) of non-submerged dental implants,
seen at initial placement, be successfully reconstructed using the guided bone
regeneration (GBR) technique with a mixture of Straumann bone ceramic and
locally harvested autogenous bone chips covered with Membragel up to 1 years
after functional loading ?
Study design
For group A and B: a prospective randomized multicenter clinical study with
1-year follow-up
For group C, the reference group: observational prospective multicenter study
with consecutive patients with 1-year follow-up
Intervention
Group A: the bony defect is reconstructed with a mixture of autogenous bone
and Straumann bone ceramic and covered with a membrane (Membragel)
Group B: the bony defect is reconstructed with a mixture of autogenous bone
and Straumann bone ceramic without use of a membrane
Study burden and risks
The measurements performed in this research are analyses of the peri-implant
soft tissue and radiological analyses. Participation in this research is not
dangerous and the patients are not at risk. The radiographs (before and after
placing the implants) are taken anyway wether or not the patient is
participating in this research. Radiological follow-up is not dangerous, the
health of the patients is not at risk. Because the treatments are already
performed for many years we expect no unknown or known incidences. In case of
pregnancy the treatment is not performed. In case the patient wants to withdraw
from this research this does not have any consequence. The treament will be
identical. However, the sofar collected measurements data can not be used
anymore for this research.
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
1) Over 18 years of age
2) Need for an implant-supported crown to replace a maxillary tooth at the location of an incisor, cupsid or first/second bicuspid
3) Single tooth diastema as a maximum
4) Presence of a small bone deficiency of less than 4 mm
5) Sufficient occlusal and mesio-distal dimensions for insertion of one implant with a functional prosthetic restoration.
Exclusion criteria
1) Presence of clinical active periodontal disease.
2) Presence of an acute inflammatory oral disease.
3) Smoking.
4) Diabetes.
5) A history of radiotherapy in the head-and-neck region or current chemotherapy
6) Disability (mental and/or physical) to maintain basic oral hygiene procedures.
7) Under eighteen years of age
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL34657.078.11 |
| OMON | NL-OMON28365 |