Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05927181 |
| Other study ID # |
TMA-USE-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2009 |
| Est. completion date |
February 2020 |
Study information
| Verified date |
May 2023 |
| Source |
Universidad Complutense de Madrid |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim was to compare two protocols for immediate implants with fixed provisional
restoration, no grafting (trimodal approach=TA) versus grafting both osseous gap and
peri-implant mucosa (trimodal approach with modification of the osseous and mucosal
compartments =TAOM) by measuring the soft tissue changes overtime. The periodontal phenotype
was registered, to investigate a relationship between its thickness and the clinical
outcomes.
Description:
The study protocol was approved by the CEIm Quiron Salud Catalunya institutional research
ethic committee (Approval code:2022/102_MAX:CEX). This prospective clinical study includes
patients who were enrolled and treated in two private practices (GC and JGF). All eligible
patients were consecutively selected for two study groups receiving immediately placed
flapless implants and the provisional restoration. Patients were informed about the
characteristics of the study and signed their informed consent before the study began.
Patient population
Patients in need of single implant supported restorations in the anterior maxilla (canines,
lateral and central incisors) were selected for this study. The indications for tooth
extractions were cavities, endodontic complications (e.g., root fracture), internal
resorption and prosthetic reasons. The patients had to fulfil the following inclusion and
exclusion criteria:
Inclusion criteria:
- ≥18 years of age
- Need for tooth extraction in the anterior maxilla (13-23) due to cavities, internal
resorption, fractures, restorative problems, endodontic complications and prosthetic
reasons.
- The failing tooth has adjacent and opposing natural teeth
- Adequate oral hygiene (Bleeding on probing <20%; Plaque index <20%);
- Absence of active and uncontrolled periodontal disease
- Sufficient mesial-distal and interocclusal space for implant placement and definitive
restoration
- Sufficient interocclusal space to design a non-occluding provisional restoration
Exclusion criteria:
- Systemic metabolic or osseous disease that could compromise peri-implant tissue healing
- Acute infection in the treatment area
- Absence of one or both adjacent teeth
- Non-integrity of the buccal bone wall (dehiscence or fenestration) observed during
surgery, or when tooth extraction has altered the integrity of the osseous and gingival
architecture
The participants were screened by two investigators (GC & JGF) and comprised two consecutive
study groups with the following interventions:
1. Flapless immediate implant placement and provisional restoration (trimodal approach: TA)
(n=15).
2. Flapless immediate implant placement and provisional restoration with alveolar filling
and connective tissue graft (trimodal approach with osseous and mucosal compartment
modification: TAOM) (n=16).
Treatment protocol and follow-up
Four visits were intended to be delivered in each participant. Following the selection of
candidates, study casts were prepared for all patients as well as preoperative photographs
and parallel periapical radiographs of the problematic tooth. Rigid stents were prepared with
light-cured resin, covering the incisal edges of at least one adjacent tooth on each side of
the target tooth. Measurements from reference points to mid-buccal soft tissue height and
mesial and distal papillae were recorded at T0. The stents were > 2 mm thick so they could be
modified to allow for a perfect fit over the final restoration.
All surgical procedures were performed by two experienced surgeons and investigators (GC&
JGF). Without raising a mucoperiosteal flap, a careful tooth extraction was performed,
allowing for the preservation of soft and hard tissues. In 10 patients, the Benex Extractor®
(Benex Root Extraction System, Hager and Meisinger GMbH, Neuss, Germany) was used to ensure
atraumatic extraction. Then, a detailed examination of the buccal bone wall was carried out
to verify its integrity. In the cases when the integrity of the bone wall was in question,
the patient was excluded from the study and the implant was placed by means of conventional
protocols.
Measurement of the total periodontal thickness (phenotype) was taken at this time by means of
an analogic calliper located 5 mm apical to the buccal gingival margin, to locate the bundle
bone level.
Then, the implant bed was prepared on the palatal side of the extraction socket in accordance
with the manufacturer's instructions (Bone Level -BL- and Tissue Level -TL-, Straumann AG,
Switzerland; Thoma et al., 2021). The implant was placed securing the ideal position at a
depth of 2mm for the TL implant and 4mm for the BL implant and in a palatal position allowing
for a direct screw-retained restoration (1-3 mm from the bone wall) for all implants. It was
also verified that the wall of the post-extraction socket was not perforated during implant
bed preparation. The implant had to show good primary stability in its ideal position, in
order to avoid being excluded from the study. In the TA group, no material was used to fill
the gap between the implant and the osseous wall and no soft tissue graft was attempted
either. In the TAOM group, the gap between the implant and the facial bone wall was grafted
with inorganic bovine bone (Geistlich Bio-Oss®; Geistlich Pharma AG, Wolhusen, Switzerland)
and, in addition, a connective tissue graft (CTG) was harvested from the anterior palate
region and placed submucosally on the labial bone plate by means of an envelope technique.
Following implant placement, an acrylic resin implant-supported provisional restoration was
prepared, adapted and delivered for all implants. All provisional restorations were directly
screw-retained and designed with no occlusal contacts, neither in maximum intercuspal
position nor in excursive movements. The emergence profile was mainly flat or concave in
interproximal and palatal sides, and slightly convex in the buccal aspect to support the soft
tissues for the TA group. In the TAOM group, it was slightly concave to provide space for the
soft-tissue graft and avoid isquemia in the marginal mucosa. Intra-oral radiographs were
taken to check implant position and the fit of the restoration. Systemic antibiotics
(Azitromicin-500mg/24h/3days) and anti-inflammatories (Dexketoprofen-25mg/8h/3days) were
prescribed, together with a clorhexidine 0.20 % gel twice a day for one week. Patients were
then recalled for a post-operative check-up and sutures were removed after 14 days.
At 3 months, final impressions were made. After abutment selection and bisque try-ins, final
restorations were permanently placed at 4 months.
The tooth-supported acrylic resin measuring stent was then adapted to allow for a complete
fit on the incisal edges of both neighbouring teeth, to ensure a reliable positioning and
measurement reference.
The first measurement was at day 0 (Immediate implant placement and provisionalisation).
Patient recall appointments for examinations and measurements took place at 3, 6 and 12
months. No activities were performed to increase compliance or adherence in the selected
patients beyong compliance of a good clinical practice.
Outcome measures The primary outcome variable of this study was the vertical midfacial soft
tissue change from baseline (before tooth extraction) to 12 months following implant
placement.
The secondary outcome measures were mesial and distal papillae vertical changes, periodontal
phenotype at implant site, and mechanical complications.
The clinical outcomes were measured as follows:
- Vertical soft tissue changes were calculated through the distance from reference
measuring points on the stent to mesial (MP) and distal (DP) papillae, and gingival
zenith (Z) of the implant restoration. Distances were measured by means of a precision
digital calliper that can display measurements as small as tenths of a millimetre. Three
dimples were marked in the stent, in approximately the vertical projection of papillae
and zenith (Supplementary figure 1a). Measurements were taken before tooth extraction
(baseline) T0 and at 3 (T3), 6 (T6) and 12 (T12) months following the intervention.
- Periodontal phenotype thickness was measured by means of an analogical calliper that was
able to show tenths of a millimetre. It was located 5 mm apical to the buccal gingival
margin immediately after tooth extraction.
- Mechanical complications were assessed and included: screw loosening, loss of retention,
chipping of acrylic or porcelain complications.
