Controlled Pilot Study to Assess Soft Tissue Reaction at the Crestal Part of a Dental Implant With ESTA Surface

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Controlled Clinical Pilot Study to Assess Soft Tissue Reaction at the Crestal Part of a Dental Implant With ESTA Surface

Conditions
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Teeth Loss

Intervention / Treatment
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* Device: Standard Plus ESTA STL Roxolid implant
* Device: Standard Plus STL implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have voluntarily signed the informed consent form before any study related action Males and females must be at least 18 years of age and not more than 80 years old. Partially edentulous in posterior (position 3-7) maxilla or mandible with implants planned for single crowns in an area with a healed extraction socket. Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann Soft Tissue Level implant of 4.1mm diameter without augmentation (at least 1mm bone buccally and lingually/palatal) Exclusion Criteria: Oral surgery contraindicated according to the judgement of the investigator (should be explained in the CRF) Local inflammation, including untreated periodontitis Patients with inadequate oral hygiene or unmotivated for adequate home care. Full mouth plaque index > 25% at time of surgery Presence of conditions requiring chronic routine prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements) Major systemic diseases Medical conditions requiring prolonged use of steroids Current pregnancy or breastfeeding women Physical handicaps that would interfere with the ability to perform adequate oral hygiene Use of any investigational drug or device within the 90 day period immediately prior to implant surgery on study day 0 Alcoholism or chronically drug abuse Smokers; more than 10 cigarettes per day Immuno-compromised patients Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability. Secondary Exclusion Criteria: GBR procedures at or adjacent to the planned study site Lack of primary stability of the dental implant at site of interest (e.g., rotational movement of the implant at a minimum of 15 Ncm torque at connection of the healing abutment, or tactile mobility)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Plus ESTA STL Roxolid implant<br>This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). | Device: Standard Plus ESTA STL Roxolid implant<br>* 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.<br>|
| Active Comparator: Standard Plus STL implant<br>This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. | Device: Standard Plus STL implant<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Isolated bleeding spots are recognizable Confluent bleeding line along the marginal mucosa Profound bleeding. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Isolated bleeding spots are recognizable Confluent bleeding line along the marginal mucosa Profound bleeding. | 3 years | 
| Soft Tissue Healing Evaluation | Assessment of the wound healing by classifying the implantation site (normal or compromised healing). | 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. | 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 | 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. | 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 | 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. | 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. | 3 years | 
| Adverse Events | All subjects are monitored continuously for adverse event. | up to 3 years |