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

NCT06737263 | Active Not Recruiting

• 1 other identifier: BioHPP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-implant Soft Tissue Healing

Outcome Measures

Primary Outcomes (1)

• Mean Bone level

  in millimeters

  36 months after implantation

Secondary Outcomes (4)

• Plaque index

  36 months after implantation

• Bleeding on probing

  36 months after implantation

• Probing depth

  36 months after implantation

• Occurrence of complications

  36 months after implantation

Study Arms (3)

BioHPP

EXPERIMENTAL

High Performance Polymer as abutment material

Device: BioHPP abutment

Titanium

ACTIVE COMPARATOR

Titanium as abutment material

Device: Titanium abutment

Zirconia

ACTIVE COMPARATOR

Zirconia as abutment material

Device: Zirconia abutment

Interventions

BioHPP abutment DEVICE

Patients in the test group receive abutments made of BioHPP

BioHPP

Titanium abutment DEVICE

Patients in the control group receive abutments made of titanium

Titanium

Zirconia abutment DEVICE

Patients in the control group receive abutments made of zirconia

Zirconia

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Oral Surgery and Radiology

Graz, 8010, Austria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: February 13, 2019
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

AU (1)