Peri-implant Soft Tissue HealingNCT06737263
Comparison of BioHPP (High Performance Polymer) - vs Titanium- vs Zirconia Abutments
A study testing BioHPP abutment, Titanium abutment and Zirconia abutment in people with Peri-implant Soft Tissue Healing, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Peri-implant Soft Tissue Healing
- What is being tested?
- BioHPP abutment, Titanium abutment and Zirconia abutment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 13 Feb 2019to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Patients undergoing local radiation or bisphosphonate therapy.
- Patients requiring sinus augmentation or soft tissue augmentation.
- Participation in another dental study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Peri-implant Soft Tissue Healing
- Being tested
- BioHPP abutment, Titanium abutment, Zirconia abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioHPP abutmentDevice
Patients in the test group receive abutments made of BioHPP
Titanium abutmentDevice
Patients in the control group receive abutments made of titanium
Zirconia abutmentDevice
Patients in the control group receive abutments made of zirconia
| Study group | Role | What they receive |
|---|---|---|
| BioHPP | Experimental | High Performance Polymer as abutment material Receives: Device: BioHPP abutment |
| Titanium | Active comparator | Titanium as abutment material Receives: Device: Titanium abutment |
| Zirconia | Active comparator | Zirconia as abutment material Receives: Device: Zirconia abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Bone level
in millimeters
Measured: 36 months after implantation
Secondary outcomes (4)
Plaque index
in percent
Measured: 36 months after implantation
Bleeding on probing
in percent
Measured: 36 months after implantation
Probing depth
in millimeters
Measured: 36 months after implantation
Occurrence of complications
Measured: 36 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start13 Feb 2019
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant Soft Tissue HealingStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737263
- Sponsor's protocol ID
- BioHPP
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of BioHPP (High Performance Polymer) - vs Titanium- vs Zirconia Abutments A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06737263
- Acronym / sponsor ID
- BioHPP
- Conditions
- Peri-implant Soft Tissue Healing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BioHPP | Experimental | Device: BioHPP abutmentHigh Performance Polymer as abutment material |
| Titanium | Active comparator | Device: Titanium abutmentTitanium as abutment material |
| Zirconia | Active comparator | Device: Zirconia abutmentZirconia as abutment material |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioHPP abutmentPatients in the test group receive abutments made of BioHPP | Device | BioHPP |
| Titanium abutmentPatients in the control group receive abutments made of titanium | Device | Titanium |
| Zirconia abutmentPatients in the control group receive abutments made of zirconia | Device | Zirconia |
Primary outcome
Mean Bone level
Time frame: 36 months after implantation
in millimeters
4 secondary outcomes
Plaque index
Time frame: 36 months after implantation
Bleeding on probing
Time frame: 36 months after implantation
Probing depth
Time frame: 36 months after implantation
Occurrence of complications
Time frame: 36 months after implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioHPP abutment, Titanium abutment and Zirconia abutment in people with Peri-implant Soft Tissue Healing, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Bone level (time frame: 36 months after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.