tooth loss because of trauma, extraction or parodontitis. K08.1
Conditions
Interventions
Group 1: Implant insertion of a two -piece ceramic implant in the healed socket and immediate loading of the implant with a single implant crown in the case of a single tooth replacement with a long t
Sponsors
Poliklinik für Zahnärztliche Chirurgie und Implantologie, ZZMK, Carolinum Zahnärztliches Universitäts-Institut gGmbH, Johann Wolfgang Goethe Universität Frankfurt
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: - Being in need of at least one implant for the replacement of missing or non retainable teeth in the upper or lower jaw (in regions 16 to 26 or in the lower jaw in regions 36 to 46, excluding regions 12 and 22 as well as 32,31,42 and 41 FDI (narrow gaps), due to diameter limitations of the implant investigated) - Adjacent teeth and/or implants have to be free of acute or chronical infections (e.g. periodontal or endodontic problems,peri-implantitis) - Single tooth gaps (i.e. natural tooth roots or implants present on the sides adjacent to the implant) - Opposing dentition must be natural teeth or fixed restoration - Subject shall have a stable occlusal relationship - Patient has been informed of the follow-up visits and is willing to return to the clinical center for these follow-up visits - Subjects must have voluntarily signed the informed consent form before any study related action
Exclusion criteria
Exclusion criteria: - Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled 1. diabetes) - Any contraindications for oral surgical procedures (according to instruction for use of implant system) - Patients who smoke >10 cigarettes per day or cigar equivalents, or who chew Tobacco - Bone metabolism disorders - Uncontrolled para-functional diseases (bruxism, clenching or grinding of teeth) - Disorders that impede the ability of patients to maintain adequate oral hygiene - 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 - Any patient with placed implant that cannot be immediately provisionalized or receive an individual healing abutment and need to be submerged healed - Need of extended bone augmentation before or during implant placement - Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant success at final restoration and at each follow-up for up to 3 years post-surgery as evidenced by a standardized composite outcome, including following clinical parameters: - Bleeding on Probing (BOP) - Mucosal Recession (MR), - Probing Pocket Depths (PD) - Clinical Attachment Level (CAL) Measured at: final restoration, at 6-month, 1-, 2- and 3- years post implant placement | — |
Secondary
| Measure | Time frame |
|---|---|
| Following secondary endpoint assessments will be collected and evaluated: At surgery: - ISQ (resonance frequency analysis, Osstell) - Insertion torque - Soft tissue thickness. At time of final restoration, at 6 months and at 1 year follow-up: - aMMP-8 (matrix metalloproteinases). At final restoration, at 6-months and at each follow-up for up to 3 years post-surgery: - Soft tissue esthetic parameters (Pink esthetic score (PES), evaluated by two independent judges) - Plaque index (PI) . At final restoration, at 1-and 3 years post-surgery: - Patient satisfaction (PROMs) by questionnaire (assessment of comfort, appearance, ability to chew, ability to taste, fit, general satisfaction). At pre-surgery, final restoration and at each follow-up for up to 3 years post- surgery: - Photographical documentation - Oral hygiene measures - Intraoral scan (3Shape TRIOS MOVE, for volumetric assessment of the tissues). Safety endpoints Evaluation of any (i.e. early and late) implant loss, complications (e.g. wound healing, allergic reactions) and adverse events. | — |
Countries
Germany
Contacts
Public ContactGeorgia Trimpou
Zentrum der Zahn-, Mund- und Kieferheilkunde Carolinum Zahnärztliches Universitäts-Institut gGmbH Poliklinik für Zahnärztliche Chirurgie und Implantologie
Outcome results
None listed