This study will investigate the effect on the soft tissue that is in contact with a dental implant with a modified surface of the neck (the part of the implant that is above the bone and in contact with the soft gum tissue).
This is a prospective, controlled, randomised clinical pilot study with parallel groups and blinded subject. The design has been chosen to obtain data to base a sample size calculation for future studies on by comparing the degree of mucosal inflammation of the mucosa in conjunction with the modified surface of the top of the test implant and the machined surface on the top of the control implant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
43
The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
University of Bern
Bern, Switzerland
University of Geneva
Geneva, Switzerland
Private Practice
Langenthal, Switzerland
Ardentis Clinique Dentaire
Lausanne, Switzerland
Sulcus Bleeding Index (According to Mombelli et al 1987)
The primary endpoint is the difference of Sulcus Bleeding Index (according to Mombelli et al 1987) between baseline (final loading) and 12 months. The inflammatory status of the mucosa will be evaluated by means of a UNC 15 periodontal probe. 0: No bleeding when a periodontal probe is passed along the peri-implant sulcus 1. Isolated bleeding spots are recognizable 2. Confluent bleeding line along the marginal mucosa 3. Profound bleeding.
Time frame: 12 months
Sulcus Bleeding Index (According to Mombelli et al 1987)
The inflammatory status of the mucosa will be evaluated by means of a UNC 15 periodontal probe. 0: No bleeding when a periodontal probe is passed along the peri-implant sulcus 1. Isolated bleeding spots are recognizable 2. Confluent bleeding line along the marginal mucosa 3. Profound bleeding.
Time frame: 3 years
Soft Tissue Healing Evaluation
Assessment of the wound healing by classifying the implantation site (normal or compromised healing).
Time frame: 10 days and 12 weeks
Oral Hygiene
Full mouth plaque index (FMPI) and full mouth bleeding on probing index (FMBoP) will be recorded as an indicator for the Oral Hygiene. The indexes are given in percent \[%\] calculated as the total numbers of surfaces with plaque or bleeding divided by the total number of teeth surfaces x100.
Time frame: Screening, 6, 12, 36 months
Recession of Gingival Margin Buccally and Lingually/Palatal
The recession of the gingival margin will be measured (distance from the gingival margin to the crown/implant margin) by using an UNC 15 periodontal probe. Changes in (averaged) recession at the follow-up visits 12+36 months compared to baseline visit ( final loading ) are displayed
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Time frame: 1 and 3 years
Probing Pocket Depth (PPD)
The PPD will be measured from the mucosal margin to the bottom of the periimplant pocket by means of an UNC 15 probe. Probing pocket depth (mm) - average over buccal, palatal, distal and mesial measurements.
Time frame: 6 months, 1 and 3 years
Clinical Attachment Level (CAL)
The CAL will be measured from the crown margin to the bottom of the periimplant pocket by means of an UNC 15 probe. Clinical attachment level (mm) - average over buccal, palatal, distal and mesial measurements
Time frame: 6 months, 1 and 3 years
Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements
Periapical radiographs are used to measure changes in mesial and distal bone crest levels (of the implant) from baseline (final loading) to one (1) year and three (3) years, respectively. The parameter derives from the subtraction of mesial and distal bone level linear x-ray measurements. The distance between the alveolar bone at the level of the first radiographic bone contact with the implant surface, and the shoulder of the implant will be measured to the closest 0.1mm at the mesial and distal surfaces of all implants on digitized standardized periapical x-rays using an image analysis computer programme. Bone levels are averaged over mesial+distal measurements. Since bone levels were measured from the implant shoulder, an increase in bone level over time corresponds to bone loss.
Time frame: 1 and 3 years
Dental Implant Success and Implant Loss
The implant success will be defined according to Buser et al 1990. Overall evaluation of implant success.
Time frame: 3 years
Adverse Events
All subjects are monitored continuously for adverse event.
Time frame: up to 3 years