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

Tooth Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02219139
• Other study ID #: CR 03/10 ESTA
• Secondary ID: CIV-12-10-009101
• Status: Withdrawn
• Phase: N/A
• First received: July 17, 2014
• Last updated: March 2, 2016
• Start date: December 2012
• Est. completion date: June 2015

Study information

• Verified date: March 2016
• Source: Institut Straumann AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicSwitzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Tooth Loss

Intervention

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

Locations

Country	Name	City	State
Switzerland	Universität Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Institut Straumann AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No