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

NCT02219139 | Withdrawn

• 2 other identifiers: CR 03/10 ESTACIV-12-10-009101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tooth Loss

Keywords

Edentulous; Roxolid; SLAclive surface; Titanium/zirconium

Outcome Measures

Primary Outcomes (1)

• Evaluation of Myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments.

  A biopsy will be taken at study day 70. The study abutment will be removed together with a small slice of the surrounding soft tissue to histologically evaluation.

  Inflammation assessment and biopsy at study day 70.

Secondary Outcomes (6)

• Evaluation of myeloperoxidase level of modified surface abutments compared to machined surface abutment at visit 2, 3, 4, and 6.

  20-24 weeks

• evaluation of inflammatory parameters of modified surface abutment compared to machined surface abutments

  20-24 weeks

• Evaluation of clinical inflammatory parameters of modified surface abutments compared to machined surface abutments based on modified Mombelli plaque index and modified Lobene gingival index.

  20-24 weeks

• Evaluation of subgingival plaque extension of modified surface abutments compared to machined surface abutments

  9 weeks after abutment placement

• Evaluation of soft tissue around the abutment of modified surface abutment compared to machined surface abutments

  At 8 weeks after abutment placement

Study Arms (1)

ESTA abutment Roxolid

OTHER

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.

Device: ESTA abutment Roxolid

Interventions

ESTA abutment Roxolid DEVICE

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

ESTA abutment Roxolid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (1)

Universität Bern

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Tooth Loss; Mouth, Edentulous

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Anton Sculean, Dr med dent

  University Bern, Zahnmedizinische Kliniken Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: August 18, 2014
• Study Start: December 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 3, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)