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

March 21, 2019 updated by: Institut Straumann AG

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • University of Bern
      • Geneva, Switzerland, 1211
        • University of Geneva
      • Langenthal, Switzerland, 4900
        • Private Practice
      • Lausanne, Switzerland, 1300
        • Ardentis Clinique Dentaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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).
Device: Standard Plus ESTA STL Roxolid implant
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.
ACTIVE_COMPARATOR: 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.
Device: Standard Plus STL implant
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sulcus Bleeding Index (According to Mombelli et al 1987)
Time Frame: 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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sulcus Bleeding Index (According to Mombelli et al 1987)
Time Frame: 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.
3 years
Soft Tissue Healing Evaluation
Time Frame: 10 days and 12 weeks
Assessment of the wound healing by classifying the implantation site (normal or compromised healing).
10 days and 12 weeks
Oral Hygiene
Time Frame: 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.
Screening, 6, 12, 36 months
Recession of Gingival Margin Buccally and Lingually/Palatal
Time Frame: 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
1 and 3 years
Probing Pocket Depth (PPD)
Time Frame: 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.
6 months, 1 and 3 years
Clinical Attachment Level (CAL)
Time Frame: 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
6 months, 1 and 3 years
Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements
Time Frame: 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.
1 and 3 years
Dental Implant Success and Implant Loss
Time Frame: 3 years
The implant success will be defined according to Buser et al 1990. Overall evaluation of implant success.
3 years
Adverse Events
Time Frame: up to 3 years
All subjects are monitored continuously for adverse event.
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Straumann AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anton Sculean, Prof. Dr., Universität Bern, Klinik für Parodontologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 27, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR 01/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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