Comparison of BioHPP (High Performance Polymer) - vs Titanium- vs Zirconia Abutments

Medical University of Graz

Status: Active, not recruiting

Conditions: Peri-implant Soft Tissue Healing

Treatments: Device: Zirconia abutment; Device: Titanium abutment; Device: BioHPP abutment

Study type: Interventional

Funder types: Other

Identifiers

NCT06737263

BioHPP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 3 patient groups

BioHPP

Experimental group

Description:

High Performance Polymer as abutment material

Treatment:

Device: BioHPP abutment

Titanium

Active Comparator group

Description:

Titanium as abutment material

Treatment:

Device: Titanium abutment

Zirconia

Active Comparator group

Description:

Zirconia as abutment material

Treatment:

Device: Zirconia abutment