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Teeth LossNCT02159183

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

A study testing Standard Plus ESTA STL Roxolid implant and Standard Plus STL implant in people with Teeth Loss, run by Institut Straumann AG at 4 sites in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Teeth Loss
What is being tested?
Standard Plus ESTA STL Roxolid implant and Standard Plus STL implant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
4 sitesSwitzerland
Study dates
Jan 2012to 27 Sep 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 16Show fewer
  • 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)

Trial locations and contacts

4 sites in 1 country.

Switzerland4 sites

  • University of Bern

    Bern, 3010

  • University of Geneva

    Geneva, 1211

  • Private Practice

    Langenthal, 4900

  • Ardentis Clinique Dentaire

    Lausanne, 1300

Other trials in Switzerland

About this study

Official title: 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).

Read the 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.

Conditions
Teeth Loss
Being tested
Standard Plus ESTA STL Roxolid implant, Standard Plus STL implant
Medical subject headings
Anodontia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Plus ESTA STL Roxolid implantDevice

    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.

  • Standard Plus STL implantDevice

    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.

Study groups in NCT02159183
Study groupRoleWhat they receive
Standard Plus ESTA STL Roxolid implantExperimentalThis 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).
Receives: Device: Standard Plus ESTA STL Roxolid implant
Standard Plus STL implantActive comparatorThis 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.
Receives: Device: Standard Plus STL implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

Secondary outcomes (9)

  1. 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.

    Measured: 3 years

  2. Soft Tissue Healing Evaluation

    Assessment of the wound healing by classifying the implantation site (normal or compromised healing).

    Measured: 10 days and 12 weeks

  3. 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.

    Measured: Screening, 6, 12, 36 months

  4. 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

    Measured: 1 and 3 years

  5. 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.

    Measured: 6 months, 1 and 3 years

  6. 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

    Measured: 6 months, 1 and 3 years

  7. 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.

    Measured: 1 and 3 years

  8. Dental Implant Success and Implant Loss

    The implant success will be defined according to Buser et al 1990. Overall evaluation of implant success.

    Measured: 3 years

  9. Adverse Events

    All subjects are monitored continuously for adverse event.

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2014 (estimated)
  2. Study startJan 2012
  3. Primary completionSep 2013
  4. Study completion27 Sep 2016

Why it stopped: 5-Y FUP will not result in new perception, no diff. between groups at 1+3y FUP

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02159183
Sponsor's protocol ID
CR 01/11
Status last verified
Mar 2019
First submitted
3 Jun 2014
Last updated
2 Apr 2019
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Standard Plus ESTA STL Roxolid implant and Standard Plus STL implant in people with Teeth Loss, run by Institut Straumann AG at 4 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sulcus Bleeding Index (According to Mombelli et al 1987) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02159183.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.

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