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

NCT ID: NCT06737263

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-13

Study Completion Date

2026-08-31

Brief Summary

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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

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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.

Conditions

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Peri-implant Soft Tissue Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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BioHPP

High Performance Polymer as abutment material

Group Type EXPERIMENTAL

BioHPP abutment

Intervention Type DEVICE

Patients in the test group receive abutments made of BioHPP

Titanium

Titanium as abutment material

Group Type ACTIVE_COMPARATOR

Titanium abutment

Intervention Type DEVICE

Patients in the control group receive abutments made of titanium

Zirconia

Zirconia as abutment material

Group Type ACTIVE_COMPARATOR

Zirconia abutment

Intervention Type DEVICE

Patients in the control group receive abutments made of zirconia

Interventions

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BioHPP abutment

Patients in the test group receive abutments made of BioHPP

Intervention Type DEVICE

Titanium abutment

Patients in the control group receive abutments made of titanium

Intervention Type DEVICE

Zirconia abutment

Patients in the control group receive abutments made of zirconia

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Oral Surgery and Radiology

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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BioHPP

Identifier Type: -

Identifier Source: org_study_id

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