Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05663385 |
| Other study ID # |
NL82943.078.22 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2023 |
| Est. completion date |
July 2023 |
Study information
| Verified date |
December 2022 |
| Source |
Erasmus Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Rationale: 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.
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
Intervention (if applicable): not applicable
Main study parameters/endpoints: Comparison of the level of the buccal marginal gingiva
(midfacial mucosa level) between ARP versus spontaneous healing
Secondary parameters/endpoint: 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.
Description:
Replacement of a single tooth in the esthetic zone is a demanding procedure. For optimal
esthetic results, no deficiency in both bone and soft tissue is acceptable. Immediately after
tooth extraction, the alveolar ridge undergoes horizontal and vertical bone loss (Lang et
al., 2012). This negatively influences the soft tissue contours, and thus esthetic outcome.
Although immediate placement of an implant after extraction leads to acceptable esthetic
results, there is an increased risk of mucosal recession due to the lack of adequate soft
tissue (Lang et al., 2012; Chen et al., 2014). Early implant placement, 4 to 8 weeks after
extraction, may offer advantages in terms of soft and hard tissue preservation (Sanz et al.,
2012; Buser et al., 2014). The main goals when treating the extraction socket in the esthetic
zone is to preserve as much as possible existing soft and hard tissue volume as possible for
future implant placement (Fickl et al., 2012). Landsberg described a modified ridge
preservation technique called "socket seal surgery" where flap elevation is avoided and it
combines both bone and soft tissue grafting prior to implant placement. Closing the
extraction site from the oral cavity using a thick epithelized palatal graft enables optimal
ridge preservation immediately after tooth extraction (Landsberg et al., 1994). Jung showed
that the application of a slowly resorbing biomaterial (BioOss Collagen®, Geistlich) into an
extraction socket, covered with an autogenous palatal soft tissue punch graft resulted in a
high predictability and reliability for a good esthetic result for future (early) implant
placement (Jung et al., 2004). Although a soft tissue graft is a relatively easy procedure,
patient morbidity is often associated with the second surgical site (Griffin et al., 2006).
An artificial socket seal might prevent donor morbidity associated with soft tissue grafts. A
critical determinant for stable esthetic long-term outcomes is integrity and stability of the
facial bone wall (Chen and Buser, 2014). The application of a biomaterial into an extraction
socket, covered with a collagen matrix or a soft tissue graft, resulted in less vertical and
horizontal changes of the alveolar ridge 6 months after extraction (Jung et al., 2013).
Although there seems to be no difference in the long term change of the buccal soft tissue
contour and alveolar ridge between a collagen matrix and an autogenous soft tissue punch
graft (Jung et al., 2013; Schneider et al., 2014), there is a lack in data concerning the
difference in esthetic outcome between these two methods in early implant placement.
Therefore, we evaluated esthetic and clinical outcomes and patient satisfaction following
single-tooth replacement in the anterior maxilla in patients treated with alveolar ridge
preservation(ARP) with a xenograft (Bio-Oss® Collagen) and a collagen matrix (Mucograft®
Seal) or a free connective tissue graft versus spontaneous healing up to 1 year after
functional loading (MEC-2015-016;NL49965.078.14). This study showed that ARP using a
xenogeneic bone substitute covered with a collagen matrix or a palatal graft, resulted in
less bone resorption and fewer bone augmentation procedures at early implant placement
compared to spontaneous healing (Jonker et al. 2020). One year after functional loading,
there was no difference in clinical and esthetical outcomes and similar PROMS between the
three treatment modalities (Jonker et al. 2021). In order to achieve optimal esthetic
results, both the bone and soft tissue have to be preserved as good as possible. Not much is
known about the long term stability of ARP compared to spontaneous healing and PROMs.
