Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLA

Last updated: March 24, 2025
Sponsor: Barts & The London NHS Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dental Filling

Treatment

Implant Type

Clinical Study ID

NCT06086873
160995
IRAS:329055
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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 AG, Switzerland) dental implants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: over 18 years old,

  • Gender: male and female.

  • Patient must be able and willing to follow study procedures and instructions andhave capacity to provide informed consent.

  • Patient must require tooth extraction of a maxillary first premolar or single-rootedanterior 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

Exclusion

Exclusion Criteria:

  • Systemic disease that can interfere with dental implant therapy (e.g. uncontrolleddiabetes)

  • 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 anduncontrolled diabetes type II), systemic infections or recent surgical procedureswithin 30 days of study initiation;

  • Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oralstatus (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) orbone metabolism (e.g. bisphosphonates, hormone replacement therapy,immunosuppressants) within 1 month before baseline visit;

  • HIV or viral hepatitis;

  • Physical handicaps that would interfere with the ability to perform adequate oralhygiene;

  • 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 >4mmon 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 anduncontrolled diabetes type II), systemic infections or recent surgical procedureswithin 30 days of study initiation;

  • Self-reported alcoholism or chronic drug abuse;

  • Patients suffering from a known psychological disorder or with limited mentalcapacity or language skills such that study information could not be understood,

  • Non-compliant patients, vulnerable individuals or those unable to understand writtenor verbal communication and give consent.

  • Pregnant or breastfeeding patients

  • Involvement in current research or recent involvement in any research prior torecruitment

  • Full-mouth bleeding (BOP) and plaque (PI) scores >30% or sites with periodontalpocket depth >5 mm at the completion of the pre-treatment phase.

Study Design

Total Participants: 39
Treatment Group(s): 1
Primary Treatment: Implant Type
Phase:
Study Start date:
April 11, 2024
Estimated Completion Date:
January 31, 2027

Study 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.

Connect with a study center

  • Royal London Dental Institute

    London, E1 1BB
    United Kingdom

    Active - Recruiting

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