Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06737263

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oral Surgery and Radiology

Graz, 8010, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BioHPP abutment

Device

Patients in the test group receive abutments made of BioHPP

Titanium abutment

Device

Patients in the control group receive abutments made of titanium

Zirconia abutment

Device

Patients in the control group receive abutments made of zirconia

Primary outcomes

  1. Mean Bone level

    Time frame: 36 months after implantation

    in millimeters

Secondary outcomes

  1. Plaque index

    Time frame: 36 months after implantation

    in percent

  2. Bleeding on probing

    Time frame: 36 months after implantation

    in percent

  3. Probing depth

    Time frame: 36 months after implantation

    in millimeters

  4. Occurrence of complications

    Time frame: 36 months after implantation

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.