The aim of this study is to evaluate esthetic and clinical outcomes and patient satisfaction following single-tooth replacement in the anterior maxilla in patients treated with a xenograft and a collagen matrix or a free connective tissue graft…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Comparison of the level of the buccal marginal gingiva (midfacial mucosa level)
between ARP versus spontaneous healing
Secondary outcome
Peri-implant esthetic score (PES) and white esthetic score (WES),
complications, implant survival; and success, Plaque Index, Modified bleeding
index, Gingival Index, Probing Depth, PROMs, bone and soft tissue volumetric
dimensional changes.
Background summary
Early implant placement with alveolar ridge preservation (ARP) using either a
collagen matrix or a palatal graft rendered similar esthetic, clinical and
PROMs to early implant placement without ARP, up to 1 year after functional
loading.
Study objective
The aim of this study is to evaluate esthetic and clinical outcomes and patient
satisfaction following single-tooth replacement in the anterior maxilla in
patients treated with a xenograft and a collagen matrix or a free connective
tissue graft versus spontaneous healing 5 years after loading
Study design
prospective observational study with 5-year follow-up
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 and cone beam CT
(CBCT) scans are taken, whether or not the patient is participating in this
research. In case of pregnancy the the radiographic analysis is postponed till
after pregnancy. In case the patient wants to withdraw from this research this
does not have any consequence
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
All patients were included in a prospective randomized clinical trial comparing
alveolar ridge preservation with a xenograft and a collagen matrix or a free
connective tissue graft versus spontaneous healing (MEC-2015-
016;NL49965.078.14).
Exclusion criteria
Patients treated with radiotherapy during follow-up in the head-and-neck region
or current chemotherapy; disability (mental and/or physical) to maintain basic
oral hygiene procedures.
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05663385 |
| CCMO | NL82943.078.23 |