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

Not Applicable

Terminated

Conditions: Teeth Loss

Interventions: Device: Standard Plus STL implant
Device: Standard Plus ESTA STL Roxolid implant

Registration Number: NCT02159183

Lead Sponsor: Institut Straumann AG

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 43

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Plus STL implant	Standard Plus STL implant	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.
Standard Plus ESTA STL Roxolid implant	Standard Plus ESTA STL Roxolid implant	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).

Primary Outcome Measures

Name	Time	Method
Sulcus Bleeding Index (According to Mombelli et al 1987)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Soft Tissue Healing Evaluation	10 days and 12 weeks	Assessment of the wound healing by classifying the implantation site (normal or compromised healing).
Dental Implant Success and Implant Loss	3 years	The implant success will be defined according to Buser et al 1990. Overall evaluation of implant success.
Sulcus Bleeding Index (According to Mombelli et al 1987)	3 years	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.
Recession of Gingival Margin Buccally and Lingually/Palatal	1 and 3 years	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
Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements	1 and 3 years	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.
Oral Hygiene	Screening, 6, 12, 36 months	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.
Probing Pocket Depth (PPD)	6 months, 1 and 3 years	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.
Adverse Events	up to 3 years	All subjects are monitored continuously for adverse event.
Clinical Attachment Level (CAL)	6 months, 1 and 3 years	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

Trial Locations

Locations (4): University of Bern
🇨🇭
Bern, Switzerland
University of Geneva
🇨🇭
Geneva, Switzerland
Private Practice
🇨🇭
Langenthal, Switzerland
Ardentis Clinique Dentaire
🇨🇭
Lausanne, Switzerland