Effect of Implant Surface Material and Topography on Bone Regeneration.

NCT05890469 | Completed

• 1 other identifier: IRAS:321927
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Dental Implant; Guided Bone Regeneration; Biomarkers; Saliva

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (13)

• Blood flow changes

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

• Soft tissue volume changes

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

• Peri-implant bone level

  6 months after implant loading

• Full mouth plaque score (FMPS)

  6 months after implant loading

• Full mouth bleeding score (FMBS)

  6 months after implant loading

Study Arms (2)

Zirconia surface implant and guided bone regeneration (Test)

EXPERIMENTAL

Zirconia 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).

Combination Product: Zirconia surface implant and guided bone regeneration

Hydrophilic titanium surface implant and guided bone regeneration (Control)

OTHER

Hydrophilic 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).

Combination Product: Hydrophilic titanium surface implant and guided bone regeneration

Interventions

Zirconia surface implant and guided bone regeneration COMBINATION_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).

Zirconia surface implant and guided bone regeneration (Test)

Hydrophilic titanium surface implant and guided bone regeneration COMBINATION_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).

Hydrophilic titanium surface implant and guided bone regeneration (Control)

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Queen Mary University of London: lead
• University of Zurich: collaborator

Study Sites (2)

Barts Health NHS Trust Dental Hospital

London, E1 1BB, United Kingdom

Location

Centre for Oral Clinical Research

London, E1 2AD, United Kingdom

Location

Study Officials

• Nikolaos Donos

  QMUL

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: June 6, 2023
• Study Start: December 1, 2023
• Primary Completion: January 27, 2025
• Study Completion: January 27, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

GB (2)