Peri-implant Soft Tissue Healing
Conditions
Brief summary
The project is a prospective, randomized, controlled study. The material BioHPP (High Performance Polymer) is compared with the gold-standard abutment materials titanium and zirconia in terms of peri-implant soft tissue healing.
Detailed description
A total of 60 participants are divided into three groups of 20 persons each. One group receives BioHPP abutments, while the two control groups receive titanium or zirconia abutments. The patients are provided with closed healing dental implants. After 3 months, following implant exposure and optical impression, the implants are restored with individual abutments. Follow-up appointments are scheduled at 3, 6, 12, 24, and 36 months after implantation. During these visits, implant healing is assessed based on clinical parameters such as probing depth, plaque index, mean bone level, and bleeding on probing.
Interventions
DEVICEBioHPP abutment
Patients in the test group receive abutments made of BioHPP
DEVICETitanium abutment
Patients in the control group receive abutments made of titanium
DEVICEZirconia abutment
Patients in the control group receive abutments made of zirconia
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * The patients must be between 18 and 99 years old. * non-smokers, former smokers, or light smokers (fewer than 10 cigarettes per day). * ASA ( American Society of Anesthesiologists) Class I or II. * There must be no pregnancy or breastfeeding period. * the patients must have an edentulous section of up to 3 teeth in the maxillary or mandibular region, where it is possible to place an implant * no allergy to any of the study-related materials
Exclusion criteria
* Patients under 18 or over 99 years old. * Heavy smokers or former heavy smokers who quit less than five years ago * Existing pregnancy or breastfeeding period. * Individuals classified as ASA Class III to V. * Presence of a polymer allergy. * Patients with severe systemic diseases, immune deficiencies, or on corticosteroid medication. * Patients undergoing local radiation or bisphosphonate therapy. * Patients requiring sinus augmentation or soft tissue augmentation. * Participation in another dental study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Bone level | 36 months after implantation | in millimeters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque index | 36 months after implantation | in percent |
| Bleeding on probing | 36 months after implantation | in percent |
| Probing depth | 36 months after implantation | in millimeters |
| Occurrence of complications | 36 months after implantation | — |
Countries
Austria
Outcome results
None listed