This study aims to evaluate and compare the long-term outcomes of tissue-level and bone-level single implants in the posterior region of the mandible or maxilla in patients with adequate bone for implant placement, with or without prior bone…
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The marginal bone level around the implants/ Distance from implant shoulder to
first bone-to-implant contact (MBL/DIB) using a standardized digital intra-oral
radiograph.
Secondary outcome
Secundary study parameters
We will use Polymerase Chain Reaction (PCR) to detect the micro-organisms.
Culture samples will be taken as well, to detect culturable species in the
sample regions.
Tertiary study parameters
1. Soft tissue volume (STV), Evaluation of the soft tissue contour changes
using an intraoral scan before implant placement and after 12 months of
loading. The obtained standard tessela-tion language (stl)-files are imported
into a software for profilometric analysis (Swiss-meda/SMOP)
2. Peri-implant esthetic score (PES) (Belser et al. 2009); this 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.
3. White esthetic score (WES) (Belser et al. 2009); this WES is based on the
five following items: general tooth form; outline and volume of the clinical
crown; colour, which includes the assessment of the dimension*s hue and value;
surface texture; and translucency and charac-terization).
KMW: The KMW buccal to the implant-supported crown was measured using the
"Attached Mucosa Index." 0 = no keratinized epithelium available, 1 = 1 mm or
less of keratinized epithelium, 2 = between 1 and 2 mm of keratinized
epithelium, and 3 = more than 2 mm of keratinized epithelium.
5: Radiographic evaluation of the alveolar ridge using CBCT (Jung et al. 2013).
6: PI: the Mombelli index was used to qualify the amount of plaque retained
(Mombelli et al. 1987). 0=no detection of plaque, 1=plaque can be detected by
running a probe across the surface of the crown, 2=plaque can be seen with the
naked eye, and 3=abundance of plaque material.
7: BI: the Mühlemann index modified by Mombelli was used (Mühlemann et al.
1987). 0=no bleeding when using a periodontal probe, 1=isolated bleeding spots
visible, 2=a confluent red line of blood along the gingival margin, 3=heavy or
profuse bleeding.
8: GI (Löe & Silness 1963). 0=normal gingiva/mucosa around the tooth/implant,
1=mild inflam-mation; slight change in colour, slight oedema, 2=moderate
inflammation; redness, oedema and glazing, 3=severe inflammation; marked
redness and oedema, ulceration.
9: PPD: The distance between the marginal border of the gingiva and the tip of
the pocket probe was scored as the PPD.
10: PROM. (Jonker et al. 2021) A patient*s questionnaire includes a visual
analog scales (VAS) that will focus on the esthetic result of the dental crown,
the peri-implant tissue, experi-enced pain and swelling. This will include a
VAS with a scale from 0 (very unsatisfied) to 10 (very satisfied).
Background summary
Dental implant treatment replaces missing teeth, with success heavily
influenced by the implant's characteristics. One major criterion for success is
the amount of marginal bone loss (MBL) around the implant, which occurs due to
factors like surgery trauma, biological width formation, micromovement, and
plaque accumulation. Implants come in two main types: tissue-level implants
(TLI) and bone-level implants (BLI). Both types are widely used, but there is
no consensus on which performs better. Aesthetic considerations often make BLIs
preferable in the front jaw area, though TLI implants offer advantages like a
polished coronal part that supports soft tissue adaptation. However, TLIs can
risk neck exposure in thin tissue biotypes, while BLIs may face inflammation
and micromotion issues, potentially leading to MBL and soft tissue recession.
Studies reveal no significant MBL difference between TLI and BLI, though BLI is
more susceptible to peri-implantitis due to its placement near the alveolar
bone. However, research on bacterial biofilm and other clinical factors remains
limited. Bone augmentation procedures are sometimes required for implants in
patients with low bone volume, with TLIs showing less bone loss but higher
implant failure risk in such cases. This study aims to compare the biofilm
composition, clinical and aesthetic outcomes, and patient satisfaction for
single-tooth implants in the back jaw region, assessing both BLIs and TLIs in
patients with adequate bone volume.
Study objective
This study aims to evaluate and compare the long-term outcomes of tissue-level
and bone-level single implants in the posterior region of the mandible or
maxilla in patients with adequate bone for implant placement, with or without
prior bone augmentation. The primary focus is to assess if there is a
difference in marginal bone loss over a 5-year follow-up. Secondary goals
include comparing the biofilm composition and microbial colonization on
tissue-level versus bone-level implants and observing any differences between
implant biofilm and the natural oral flora in the posterior region.
Additionally, the study examines if tissue-level implants provide superior soft
tissue contour, clinical outcomes, and patient satisfaction regarding esthetics
compared to bone-level implants over the same period.
Study design
A randomized clinical trial (RCT) that will take place in the Erasmus Medical
Center Rotter-dam.
Expected duration of inclusion will be 6 months. Implants (either Tissue level
or Bone level) will be placed, and the loading time will occur another 4-6
months. Follow- up will be performed 1, 3 and 5 years after loading.
Intervention
Patients are first randomized into either the Tissue Level Implant (TLI) or
Bone Level Implant (BLI) group. After local anesthesia, a mucoperiosteal flap
is raised to expose the bone, with implant placement guided by a predesigned
surgical template based on CBCT and IOS data.
Bone is drilled sequentially with saline irrigation, with adjustments to
drilling speed and depth based on bone density. Implants are inserted with a
torque of 35-45 Ncm to ensure primary stability. TLI implants are positioned at
the soft tissue level, while BLI implants are placed at the bone level. If
buccal bone is less than 3mm thick or dehiscence is present, guided bone
regeneration (GBR).
In one-stage surgeries, a healing abutment may be placed immediately to avoid a
second surgery. The flap is then closed with tension-free, resorbable sutures,
and patients are instructed to use a chlorhexidine rinse and follow a soft
diet. Follow-ups occur at 2 weeks post-surgery, and implants are left
undisturbed for 12 weeks to allow proper healing and osseointegration. After 12
weeks, implants are loaded with a screw-retained ceramic crown to enable easier
maintenance and minimize cement-related complications.
Study burden and risks
Participating in the clinical trial comparing tissue level implants (TLI) and
bone level implants (BLI) involves no additional risks beyond those associated
with standard dental treatments. The procedures are performed by experienced
oral and maxillofacial surgeons, ensuring that participants receive
high-quality care comparable to routine clinical practice. The primary
difference lies in the group setting, where participants will receive their
implants and crowns at no cost, as the treatment is part of the study. This
funding alleviates the financial burden typically associated with dental
implant procedures.
While there are numerous benefits, one potential drawback is that patients may
need to travel further to participate in the study, which could require a small
time investment for follow-up appointments. However, the advantages of
receiving comprehensive monitoring and care, alongside the opportunity to
contribute to valuable research in implant dentistry, outweigh this
inconvenience. Additionally, being part of a study group can foster a sense of
camaraderie among participants, as they share their experiences and support one
another throughout the treatment process. Ultimately, this study aims to
improve understanding and outcomes of dental implant treatments, benefiting
both current participants and future patients.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, a subject must meet all the
following criteria:
- A minimum age of 18 years old
- Missing (pre)molar in the mandibule or maxilla
- Healed sites with or without previous augmentation procedures
- Sufficient bone for implant placement
- At least one adjacent tooth
Exclusion criteria
Patients were excluded if they meet one of the following exclusion criteria:
- Patients with systemic medical conditions or diseases that may significantly
affect immune function: uncontrolled diabetes, immunodeficiency disorders or
current chemotherapy.
- Patients treated with radiotherapy during follow- up in the head and neck
region
- Pregnant or lactating individuals (hormonal changes during these periods can
affect oral health and microbial colonization)
- Severe oral conditions (extensive periodontal disease, periimplantitis,
active oral infections, or mucosal lesions)
- Smoking or alcohol abuse
- Antibiotic use
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 |
|---|---|
| CCMO | NL88164.078.25 |