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

Comparison of BioHPP (High Performance Polymer) - vs Titanium- vs Zirconia Abutments A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Peri-implant Soft Tissue Healing
• Intervention / Treatment: Device: BioHPP abutment; Device: Titanium abutment; Device: Zirconia abutment

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8010
    • Department of Oral Surgery and Radiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BioHPP; High Performance Polymer as abutment material	Device: BioHPP abutment; Patients in the test group receive abutments made of BioHPP
Active Comparator: Titanium; Titanium as abutment material	Device: Titanium abutment; Patients in the control group receive abutments made of titanium
Active Comparator: Zirconia; Zirconia as abutment material	Device: Zirconia abutment; Patients in the control group receive abutments made of zirconia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Bone level	in millimeters	36 months after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index	in percent	36 months after implantation
Bleeding on probing	in percent	36 months after implantation
Probing depth	in millimeters	36 months after implantation
Occurrence of complications		36 months after implantation

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BioHPP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No