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

A Comparative, Randomized, Prospective, Clinical Pilot Study to Evaluate the Performance of Modified Study Abutments in Single Tooth Gaps

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

Study Overview

• Status: Withdrawn
• Conditions: Tooth Loss
• Intervention / Treatment: Device: ESTA abutment Roxolid

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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Universität Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Device: ESTA abutment Roxolid; Enhanced Soft Tissue Attachment surface on Roxolid or machined surface on Roxolid abutment placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of myeloperoxidase level of modified surface abutments compared to machined surface abutment at visit 2, 3, 4, and 6.	A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24.	20-24 weeks
evaluation of inflammatory parameters of modified surface abutment compared to machined surface abutments	A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24.	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.	A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24.	20-24 weeks
Evaluation of subgingival plaque extension of modified surface abutments compared to machined surface abutments	Patients will be asked to suspend oral hygiene in the area of the abutment. after 42-49 days after abutment placement for 14 days. At study week 8 a histological sample will be taken	9 weeks after abutment placement
Evaluation of soft tissue around the abutment of modified surface abutment compared to machined surface abutments	8 weeks after abutment placement patients have been asked for 14 days of abdication of oral hygiene. A histological sample will be taken then.	At 8 weeks after abutment placement
Evaluation of bacterial community at the abutment site	At study day 42-49, day 49-56, day 56-63, and day 77-105 a microbiological sample will be taken	28 days

Collaborators and Investigators

• Sponsor: Institut Straumann AG
• Investigators: Principal Investigator: Anton Sculean, Dr med dent, University Bern, Zahnmedizinische Kliniken Bern

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: July 17, 2014
• First Submitted That Met QC Criteria: August 14, 2014
• First Posted (Estimate): August 18, 2014

Study Record Updates

• Last Update Posted (Estimate): March 3, 2016
• Last Update Submitted That Met QC Criteria: March 2, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Edentulous; Roxolid; SLAclive surface; Titanium/zirconium
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: CR 03/10 ESTA; CIV-12-10-009101 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No