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Dental ImplantNCT06086873

Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLA

A study testing Implant Type in people with Dental Implant, run by Barts & The London NHS Trust at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to characterise the stability of crestal bone levels one year after loading, the associated aesthetic outcomes, immunological response, prosthodontic outcomes as well as overall patient reported outcome measures for modSLA (SLActive, Institut Straumann AG, Switzerland) and NGA (TiUltraNP, Nobel Biocare… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dental Implant
What is being tested?
Implant Type
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited Kingdom
Study dates
5 Sep 2023to 31 Mar 2027
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age: over 18 years old,
  • Gender: male and female.
  • Patient must be able and willing to follow study procedures and instructions and have capacity to provide informed consent.
  • Patient must require tooth extraction of a maxillary first premolar or single-rooted anterior tooth as the result of caries, endodontic failure or trauma
  • The extraction site must have adjacent teeth present.
  • Adjacent teeth with no evidence of interdental bone loss

Who cannot join

  • Systemic disease that can interfere with dental implant therapy (e.g. uncontrolled diabetes)
  • 2 adjacent teeth requiring extraction
  • Greater than one wall of the socket missing - assessed at time of extraction
  • Any contraindications for oral surgical procedures
  • Any known systemic disease affecting bone metabolism (e.g. Cushing's syndrome, Crohn's disease, rheumatoid arthritis, osteoporosis, diabetes type I and uncontrolled diabetes type II), systemic infections or recent surgical procedures within 30 days of study initiation;
  • Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) or bone metabolism (e.g. bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit;
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  • HIV or viral hepatitis;
  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
  • History of local irradiation therapy in the head-neck region
  • Mucosal diseases (e.g. erosive lichen planus)
  • Current untreated periodontitis or gingivitis. In particular probing depths of >4mm on one of the teeth immediately adjacent to the extraction site
  • Untreated acute endodontic lesions
  • Current smokers (have smoked within 3 months of study onset)
  • Any known systemic disease affecting bone metabolism (e.g. Cushing's syndrome, Crohn's disease, rheumatoid arthritis, osteoporosis, diabetes type I and uncontrolled diabetes type II), systemic infections or recent surgical procedures within 30 days of study initiation;
  • Self-reported alcoholism or chronic drug abuse;
  • Patients suffering from a known psychological disorder or with limited mental capacity or language skills such that study information could not be understood,
  • Non-compliant patients, vulnerable individuals or those unable to understand written or verbal communication and give consent.
  • Pregnant or breastfeeding patients
  • Involvement in current research or recent involvement in any research prior to recruitment
  • Full-mouth bleeding (BOP) and plaque (PI) scores >30% or sites with periodontal pocket depth >5 mm at the completion of the pre-treatment phase.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site, 1 recruiting

  • Royal London Dental Institute

    London, E1 1BB

    Shahdad Shakeel, 02073777000, shakeel.shahdad@nhs.net

    Thomas Gill, 02073777000, thomas.gill@qmul.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Randomised Clinical Trial Investigating Effect of Implant Surface Characteristic on Crestal Marginal Bone Loss, Inflammatory Response and Aesthetic Outcomes: Novel Gradient Anodized and Sandblasted Large-grit Acid-etched Implant Surfaces

This study aims to characterise the stability of crestal bone levels one year after loading, the associated aesthetic outcomes, immunological response, prosthodontic outcomes as well as overall patient reported outcome measures for modSLA (SLActive, Institut Straumann AG, Switzerland) and NGA (TiUltraNP, Nobel Biocare AG, Switzerland) dental implants.

Read the detailed description

Ultra-hydrophilic SLActive (modSLA) implants have been extensively studied in pre-clinical and clinical studies, demonstrating their pro-osteogenic nature and long-term maintenance of facial bone and aesthetics.

A novel multi-zone novel gradient anodized (NGA) hydrophilic surface (TiUltra) has recently been introduced to clinical practice. Pre-clinical studies have demonstrated that the smoother coronal aspect achieved stable soft tissue adhesion.

In clinical practice, prosthetically driven implant placement, particularly in the anterior maxilla, may result in a buccal dehiscence that is commonly treated with guided bone regeneration (GBR). Currently no studies have been published investigating differences between these commercially available implant surfaces (modSLA, NGA).

This prospective, single centre randomised clinical trial will recruit 39 patients who require a single tooth extraction in the anterior maxilla for a Type IIc implant placement.

Patients enrolled in the study will be allocated to one of three implant groups:

  • Group 1: NGA Implant (NobelActive TiUltraNP, Nobel Biocare AG, Switzerland)
  • Group 2: BLX implant (BLX) modSLA Surface (BLX, SLActive, Roxolid, Institut Straumann AG, Switzerland)
  • Group 3: TLX implant (TLX) modSLA Surface (TLX, SLActive, Roxolid, Institut Straumann AG, Switzerland).

This study aims to characterise the stability of crestal bone levels one year after loading, the associated aesthetic outcomes, immunological response, prosthodontic outcomes as well as overall patient reported outcome measures.

Conditions
Dental Implant
Being tested
Implant Type

What participants receive

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

  • Implant TypeDevice

    Patients enrolled in the study will be allocated to one of three implant groups:

    • Group 1: NGA Implant (NobelActive TiUltraNP, Nobel Biocare AG, Switzerland)
    • Group 2: BLX implant (BLX) modSLA Surface (BLX, SLActive, Roxolid, Institut Straumann AG, Switzerland)
    • Group 3: TLX implant (TLX) modSLA Surface (TLX, SLActive, Roxolid, Institut Straumann AG, Switzerland).
Study groups in NCT06086873
Study groupRoleWhat they receive
NGA ImplantExperimentalNGA Implant (NobelActive TiUltraNP, Nobel Biocare AG, Switzerland)
Receives: Device: Implant Type
BLX implant (BLX) modSLA SurfaceExperimentalBLX implant (BLX) modSLA Surface (BLX, SLActive, Roxolid, Institut Straumann AG, Switzerland)
Receives: Device: Implant Type
TLX implant (TLX) modSLA SurfaceExperimentalTLX implant (TLX) modSLA Surface (TLX, SLActive, Roxolid, Institut Straumann AG, Switzerland).
Receives: Device: Implant Type

What is being measured

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

  1. Coronal Facial Bone Maintenance

    A numerical comparison of coronal facial bone thickness between the groups. CBCT scans will be compared to quantify the linear changes in crestal bone thickness at the coronal aspect of the implant (shoulder of NGA and BLX implants and rough-smooth transition of TLX implant).

    Measured: 1 Year post loading

Secondary outcomes (5)

  1. Aesthetic Outcome

    • A numerical comparison of the three groups from an objective aesthetic scale derived from a panel of 2 dentists.

    Measured: 1 Year post loading

  2. Patient Satisfaction

    • A numerical comparison of the patient satisfaction between the three groups derived from an analysis of patient questionnaires (Likert Scales).

    Measured: 1 Year post loading

  3. Patient Satisfaction- Aesthetics

    • A numerical comparison of the aesthetic merit between the three groups derived from an analysis of patient questionnaires (Likert scales)

    Measured: 1 Year post loading

  4. Primary Stability

    A numerical comparison of primary stability measurement of the three groups (IT, RFA).

    Measured: 1 Year post loading

  5. Immunological Response

    • A numerical and qualitative comparison of inflammatory profiles derived from peripheral blood of the three groups

    Measured: Pre-surgery to 12 Weeks post surgery

Timeline

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

  1. First posted17 Oct 2023
  2. Study start5 Sep 2023
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06086873
Sponsor's protocol ID
160995
Other IDs
IRAS:329055
Status last verified
Apr 2026
First submitted
11 Oct 2023
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Implant Type in people with Dental Implant, run by Barts & The London NHS Trust at 1 site 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 6 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 22 Apr 2026. 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 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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coronal Facial Bone Maintenance (time frame: 1 Year post loading). 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 NCT06086873.

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 22 Apr 2026.

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