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

Primary Purpose

Teeth Loss

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Standard Plus ESTA STL Roxolid implant
Standard Plus STL implant
Sponsored by
Institut Straumann AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Teeth Loss

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Bern
  • University of Geneva
  • Private Practice
  • Ardentis Clinique Dentaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Standard Plus ESTA STL Roxolid implant

Standard Plus STL implant

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Soft Tissue Healing Evaluation
Assessment of the wound healing by classifying the implantation site (normal or compromised healing).
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.
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
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.
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
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.
Dental Implant Success and Implant Loss
The implant success will be defined according to Buser et al 1990. Overall evaluation of implant success.
Adverse Events
All subjects are monitored continuously for adverse event.

Full Information

First Posted
June 3, 2014
Last Updated
March 21, 2019
Sponsor
Institut Straumann AG
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1. Study Identification

Unique Protocol Identification Number
NCT02159183
Brief Title
Controlled Pilot Study to Assess Soft Tissue Reaction at the Crestal Part of a Dental Implant With ESTA Surface
Official Title
A Controlled Clinical Pilot Study to Assess Soft Tissue Reaction at the Crestal Part of a Dental Implant With ESTA Surface
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
5-Y FUP will not result in new perception, no diff. between groups at 1+3y FUP
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 27, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Straumann AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Teeth Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Plus ESTA STL Roxolid implant
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard Plus STL implant
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Standard Plus ESTA STL Roxolid implant
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard Plus STL implant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sulcus Bleeding Index (According to Mombelli et al 1987)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Sulcus Bleeding Index (According to Mombelli et al 1987)
Description
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.
Time Frame
3 years
Title
Soft Tissue Healing Evaluation
Description
Assessment of the wound healing by classifying the implantation site (normal or compromised healing).
Time Frame
10 days and 12 weeks
Title
Oral Hygiene
Description
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
Title
Recession of Gingival Margin Buccally and Lingually/Palatal
Description
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
Time Frame
1 and 3 years
Title
Probing Pocket Depth (PPD)
Description
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
Title
Clinical Attachment Level (CAL)
Description
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
Title
Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements
Description
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
Title
Dental Implant Success and Implant Loss
Description
The implant success will be defined according to Buser et al 1990. Overall evaluation of implant success.
Time Frame
3 years
Title
Adverse Events
Description
All subjects are monitored continuously for adverse event.
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anton Sculean, Prof. Dr.
Organizational Affiliation
Universität Bern, Klinik für Parodontologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
University of Geneva
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Private Practice
City
Langenthal
ZIP/Postal Code
4900
Country
Switzerland
Facility Name
Ardentis Clinique Dentaire
City
Lausanne
ZIP/Postal Code
1300
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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