A Comparative, Randomized, Prospective, Performance Evaluation of Abutments in Single Tooth Gaps

NCT ID: NCT02219139

Last Updated: 2016-03-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-06-30

Brief Summary

Immunologically evaluation of myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments.

Detailed Description

One study abutment per patient will be placed. After healing for 6 to 7 weeks, patients will be asked to stop oral hygiene at the study site for 2 weeks.

Sulcus fluid and plaque samples will be taken at the abutment site at several visits before and during abdication of oral hygiene.

The study finishes with biopsy visit. Afterwards a regular abutment will be placed and the patients will be treated according to the standard protocol of the clinic to obtain their final restoration

Conditions

Tooth Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

ESTA abutment Roxolid

One study abutment per patient will be placed. After healing for 6 to 7 weeks, patients will be asked to stop oral hygiene at the study site for 2 weeks.

Sulcus fluid and plaque samples will be taken at the abutment site at several visits before and during abdication of oral hygiene.

The study finishes with biopsy visit. Afterwards a regular abutment will be placed and the patients will be treated according to the standard protocol of the clinic to obtain their final restoration.

Group Type: OTHER

ESTA abutment Roxolid

Intervention Type: DEVICE

Enhanced Soft Tissue Attachment surface on Roxolid or machined surface on Roxolid abutment placement.

Interventions

ESTA abutment Roxolid

Enhanced Soft Tissue Attachment surface on Roxolid or machined surface on Roxolid abutment placement.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects must have voluntary signed the informed consent form before any study related action.
• Males and females with at least 18 years of age
• Non-smokers
• Straumann bone level implant (healed for at least 4 weeks) in a tooth gap in the maxilla or mandible with thick tissue biotype
• Adequate oral hygiene (Full mouth plaque index; O'Leary, et al. 1972) <25% at abutment placement
• The patient must be able to open the mouth to allow removal of the abutment at the planned abutment site

Exclusion Criteria

• Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
• Any antibiotic treatment or anti-inflammatory treatment within the past 2 month
• Any contraindications for oral surgical procedures
• Mucosal diseases (e.g. lichen planus, mouth ulcer)
• History of local irradiation therapy
• Current treated (within the last 12 month) or untreated periodontitis
• Current treated (within the last 6 month) or untreated gingivitis
• Probing pocket depth of ≥4 mm on one of the teeth immediately adjacent to the dental implant site
• Severe bruxing or clenching habits
• Lack of primary stability of the implant at abutment placement
• Subjects who have undergone administration of any investigational device within 30 days of enrolment in the study
• 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
• Physical or mental handicaps that would interfere with the ability to follow protocol procedures
• Pregnant or breastfeeding wome
• Insufficient soft tissue attachment to the neck of the abutment (e.g. visibility of the abutment platform or exposed ESTAnsurface) after abutment placement

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Straumann AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anton Sculean, Dr med dent

Role: PRINCIPAL_INVESTIGATOR

University Bern, Zahnmedizinische Kliniken Bern

Locations

Universität Bern

Bern, Canton of Bern, Switzerland

Countries

Switzerland

Other Identifiers

CIV-12-10-009101

Identifier Type: OTHER

Identifier Source: secondary_id

CR 03/10 ESTA

Identifier Type: -

Identifier Source: org_study_id