bone erosion around the implant marginal bone loss
Conditions
Interventions
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.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 & Silne | — |
Countries
Netherlands
Outcome results
None listed