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

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

Detailed Description
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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

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

Conditions
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Tooth Loss

Intervention / Treatment
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* Device: ESTA abutment Roxolid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ESTA abutment Roxolid<br>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<br>* Enhanced Soft Tissue Attachment surface on Roxolid or machined surface on Roxolid abutment placement.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Edentulous, Roxolid, SLAclive surface, Titanium/zirconium