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

NCT02159183 | Terminated Results

• 1 other identifier: CR 01/11
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 4

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).

Conditions

Teeth Loss

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (9)

• Sulcus Bleeding Index (According to Mombelli et al 1987)

  3 years

• Soft Tissue Healing Evaluation

  10 days and 12 weeks

• Oral Hygiene

  Screening, 6, 12, 36 months

• Recession of Gingival Margin Buccally and Lingually/Palatal

  1 and 3 years

• Probing Pocket Depth (PPD)

  6 months, 1 and 3 years

Study Arms (2)

Standard Plus ESTA STL Roxolid implant

EXPERIMENTAL

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

Standard Plus STL implant

ACTIVE COMPARATOR

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

Interventions

Standard Plus ESTA STL Roxolid implant DEVICE

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 ESTA STL Roxolid implant

Standard Plus STL implant DEVICE

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.

Standard Plus STL implant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (4)

University of Bern

Bern, 3010, Switzerland

Location

University of Geneva

Geneva, 1211, Switzerland

Location

Private Practice

Langenthal, 4900, Switzerland

Location

Ardentis Clinique Dentaire

Lausanne, 1300, Switzerland

Location

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Prof. Dr. med. dent., Dr. h.c., M.S. Anton Sculean
• Organization: ZMK University of Bern, Clinic of Periodontology

anton.sculean@zmk.unibe.ch

004131 632 25 72

Study Officials

• Anton Sculean, Prof. Dr.

  Universität Bern, Klinik für Parodontologie

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 9, 2014
• Study Start: January 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 27, 2016
• Last Updated: April 2, 2019
• Results First Posted: March 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)