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Dental ImplantNCT05890469

Effect of Implant Surface Material and Topography on Bone Regeneration.

A study testing Zirconia surface implant and guided bone regeneration and Hydrophilic titanium surface implant and guided bone regeneration in people with Dental Implant and Guided Bone Regeneration, run by Queen Mary University of London at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Dental implants have been on the market for several years and they are routinely used to replace single/multiple missing teeth with a high success rate. However, there is still a limited number of studies comparing hydrophilic titanium and zirconia implants. Read more about this study

Who is it for?
Ages 25 years and older
What is being tested?
Zirconia surface implant and guided bone regeneration and Hydrophilic titanium surface implant and guided bone regeneration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited Kingdom
Study dates
1 May 2024to 9 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

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 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females, ≥ 25 years old
  • Good/controlled medical and psychological health
  • Good oral hygiene (full mouth plaque scores [FMPS< 30%])
  • Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar) region
  • At least one neighbouring natural tooth present
  • A functional occlusion with a minimum of four occlusal units (i.e., pairs of occluding posterior teeth)
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  • At least 3 months of post-extraction socket healing had occurred in the edentulous site and no ridge preservation was performed
  • After implant placement, presence of buccal bone dehiscence/fenestration or thin buccal bone plate (<2mm) requiring guided bone regeneration (GBR) (including contour augmentation) [to be confirmed after implant placement]
  • Willingness to read and sign a copy of the Informed Consent Form (ICF) after reading the Patient Information Sheet (PIS), and after the nature of the study has been fully explained and potential questions fully answered

Who cannot join

  • Any known systemic disease severely affecting bone metabolism (e.g., Cushing's syndrome, Crohn's disease, rheumatoid arthritis, osteoporosis or diabetes type I and uncontrolled diabetes type II)
  • Self-reported HIV or viral hepatitis
  • Self-reported alcoholism or chronic drug abuse
  • Smokers (including current smokers or former smokers who had quit for < 3 months); patients reporting use of vape/ e-cigarettes will also be excluded
  • Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing, which can affect interpretation of study results)
  • Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status or bone metabolism (e.g., bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit
Show all 16Show fewer
  • Chronic treatment with anticoagulants (including aspirin), corticosteroids, immunosuppressants or other medications that may influence blood coagulation/count
  • Antibiotic or anti-inflammatory therapy during the month preceding the baseline exam.
  • Untreated caries lesions and untreated/uncontrolled periodontal disease. If patients require periodontal treatment (non-surgical and/or surgical), this will be arranged outside the study protocol and completed prior to enrolment
  • Inadequate keratinized tissue width (<2 mm) in the mid-buccal aspect of the area to be treated in the study
  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene in the area of implant placement
  • Patients requiring maxillary sinus lift surgery before implant placement
  • Self-reported bruxism
  • Patients not willing to receive animal-derived biomaterials for GBR
  • Patients suffering from a known psychological disorder or with limited mental capacity or language skills such that study information could not be understood, informed consent could not be obtained, or simple instructions could not be followed
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Barts Health NHS Trust Dental Hospital

    London, E1 1BB

  • Centre for Oral Clinical Research

    London, E1 2AD

Other trials in United Kingdom

About this study

Official title: Effect of Implant Surface Material and Topography on Bone Regeneration: A Two-centre, Parallel-group, Pilot Study

Dental implants have been on the market for several years and they are routinely used to replace single/multiple missing teeth with a high success rate. However, there is still a limited number of studies comparing hydrophilic titanium and zirconia implants. In addition, there is no data available on the signalling pathways and the expression of healing biomarkers involved in the early stages of osseointegration around zirconia surface implants placed with guided bone regeneration (GBR).

This study aims 1) to describe and compare the early wound healing molecular pathways, and the 2) vascularization patterns of mucosal tissues after the placement of hydrophilic titanium or zirconia implants with simultaneous guided bone regeneration (GBR).

In this study, the investigators will assess the expression of inflammatory, angiogenesis and osseous biomarkers of PICF at 3, 7, 15 and 30 days after the placement of hydrophilic titanium or zirconia dental implants with simultaneous GBR and of saliva at day 1, 3, 7, 15 and 30.

Read the detailed description

This is a two-centre prospective, parallel-group pilot study which will consist of 10-11 visits over a minimum period of 14 months. The study will take place at the Centre for Oral Clinical Research (COCR), at the Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London (main centre), United Kingdom and at Clinic of Reconstructive Dentistry, University of Zurich, Zurich in accordance with local guidelines and procedures/interventions detailed below.

Being tested
Zirconia surface implant and guided bone regeneration, Hydrophilic titanium surface implant and guided bone regeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zirconia surface implant and guided bone regenerationCombination product

    The Straumann® PURE Ceramic Implant System is made from 100 % yttria-stabilized zirconia. Its surface features a topography characterized by macro- and micro-roughness to offer a structure for cell attachment and the osseointegration of this surface has been successfully proven. Owing to the increasing aesthetic standards in the field of implant dentistry and the concerns on sensitivity to titanium, there has been a growing interest towards metal-free implant rehabilitation.

    Guided bone regeneration (GBR) will be performed simultaneously with the implant placement with the aim to re-establish the bone contour. A bovine osteoconductive graft (Bio-Oss collagen®, Geistlich, Wolhusen, Switzerland) will be placed on the buccal aspect of the implant and covered with a collagen membrane (Bio-Gide®, Geistlich, Wolhusen, Switzerland).

  • Hydrophilic titanium surface implant and guided bone regenerationCombination product

    The Straumann® Standard Plus (SP) Implant is a Soft Tissue Level Implant with a smooth neck section of 1.8 mm. It has a fundamentally improved hydrophilic surface chemistry (SLActive®) which accelerates the osseointegration process in the early healing phase.

    Guided bone regeneration (GBR) will be performed simultaneously with the implant placement with the aim to re-establish the bone contour. A bovine osteoconductive graft (Bio-Oss collagen®, Geistlich, Wolhusen, Switzerland) will be placed on the buccal aspect of the implant and covered with a collagen membrane (Bio-Gide®, Geistlich, Wolhusen, Switzerland).

Study groups in NCT05890469
Study groupRoleWhat they receive
Zirconia surface implant and guided bone regeneration (Test)ExperimentalZirconia surface implant (Straumann PURE®, Basel, Switzerland) and guided bone regeneration (GBR) with a porcine collagen membrane (Bio-Gide®, Geistlich, Wolhusen, Switzerland) and a deproteinized bovine bone substitute (Bio-Oss Collagen®, Geistlich, Wolhusen, Switzerland).
Receives: Combination Product: Zirconia surface implant and guided bone regeneration
Hydrophilic titanium surface implant and guided bone regeneration (Control)OtherHydrophilic titanium surface implant (Straumann Standard Plus (SP) Tissue level, SLActive®, Basel, Switzerland) and guided bone regeneration (GBR) with a porcine collagen membrane (Bio-Gide®, Geistlich, Wolhusen, Switzerland) and a deproteinized bovine bone substitute (Bio-Oss Collagen®, Geistlich, Wolhusen, Switzerland).
Receives: Combination Product: Hydrophilic titanium surface implant and guided bone regeneration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the expression of inflammatory, angiogenesis and osseous biomarkers of PICF and saliva

    The expression of inflammatory, angiogenesis and osseous biomarkers of PICF at 3, 7, 15 and 30 days after the placement of hydrophilic titanium or zirconia dental implants with simultaneous GBR and of saliva at day 1, 3, 7, 15 and 30.

    Measured: 1,3, 7, 15 and 30 days after the placement of hydrophilic titanium or zirconia dental implants.

Secondary outcomes (13)

  1. Blood flow changes

    Blood flow changes immediately after, at 1, 3, 7, 15 and 30 days after implant placement (IP)

    Measured: immediately after, 1, 3, 7, 15 and 30 days after the placement of hydrophilic titanium or zirconia dental implants

  2. Soft tissue volume changes

    Soft tissue volume changes immediately after, at 1, 3, 7, 15, 30 days and 3 months after IP, at loading and 6 months after implant loading

    Measured: immediately after,1, 3, 7, 15, 30 days and 3 months after IP, at loading and 6 months after implant loading

  3. Peri-implant bone level

    Peri-implant bone level 6 months after loading, using CBCT images

    Measured: 6 months after implant loading

  4. Full mouth plaque score (FMPS)

    FMPS will be recorded as a percentage of total surfaces (6 sites per tooth/implant), which reveal the presence of plaque. A binary score will be assigned to each surface (1 for plaque present, 0 for absent).

    Measured: 6 months after implant loading

  5. Full mouth bleeding score (FMBS)

    FMBS will be recorded as percentage of total surfaces (6 aspects per tooth/implant), which reveal the presence of bleeding within 10 - 30 seconds following periodontal probing. A binary score will be assigned to each surface (1 for bleeding present, 0 for bleeding absent).

    Measured: 6 months after implant loading

  6. Probing pocket depth (PPD)

    PPD will be measured in mm using a University of North Carolina (UNC-15) periodontal probe at six sites per tooth/implant (i.e., mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual)

    Measured: 6 months after implant loading

  7. Gingival recession (REC)

    REC will be measured in mm using a University of North Carolina (UNC-15) periodontal probe at six sites per tooth/implant (i.e., mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual)

    Measured: 6 months after implant loading

  8. Clinical attachment level (CAL)

    CAL will be calculated considering the values for PPD and REC in mm

    Measured: 6 months after implant loading

  9. Suppuration

    Suppuration will be recorded as percentage of total surfaces (6 aspects per tooth/implant), which reveal the presence of suppuration following periodontal probing. A binary score will be assigned to each surface (1 for suppuration present, 0 for suppuration absent)

    Measured: 6 months after implant loading

  10. Patient satisfaction at 6 months after loading

    Patient satisfaction regarding the overall implant treatment using a subjective outcome questionnaire at 6 months post loading.

    Measured: 6 months after implant loading

  11. Changes in the pink esthetic score (PES)

    Changes in the pink esthetic score (PES) from loading to 6 months after loading

    Measured: 6 months after implant loading

  12. Changes in the white esthetic score (WES)

    Changes in the white esthetic score (WES) from loading to 6 months after loading

    Measured: 6 months after implant loading

  13. Changes in the papilla fill index (PFI)

    Changes in the papilla fill index (PFI) from loading to 6 months after loading

    Measured: 6 months after implant loading

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2023
  2. Study start1 May 2024
  3. Primary completion9 Dec 2025
  4. Study completion9 Dec 2025

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05890469
Sponsor's protocol ID
IRAS:321927
Status last verified
Jul 2026
First submitted
12 Apr 2023
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Zirconia surface implant and guided bone regeneration and Hydrophilic titanium surface implant and guided bone regeneration in people with Dental Implant and Guided Bone Regeneration, run by Queen Mary University of London at 2 sites in United Kingdom.

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 9 inclusion and 16 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: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Changes in the expression of inflammatory, angiogenesis and osseous biomarkers of PICF and saliva (time frame: 1,3, 7, 15 and 30 days after the placement of hydrophilic titanium or zirconia dental implants.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05890469.

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 Jul 2026.

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