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

Not Applicable

Active, not recruiting

• Conditions: Peri-implant Soft Tissue Healing

• Registration Number: NCT06737263
• Lead Sponsor: Medical University of Graz

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.

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 Timeline

• Study Start: 2019-02-13
• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Bone level	36 months after implantation	in millimeters

Secondary Outcome Measures

Name	Time	Method
Plaque index	36 months after implantation	in percent
Bleeding on probing	36 months after implantation	in percent
Probing depth	36 months after implantation	in millimeters
Occurrence of complications	36 months after implantation

Trial Locations

Locations (1)

Department of Oral Surgery and Radiology; 🇦🇹 Graz, Austria