Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLA

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implant
• Intervention / Treatment: Device: Implant Type

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.

• Study Type: Interventional
• Enrollment (Estimated): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E1 1BB
    • Recruiting
    • Royal London Dental Institute
    • Contact: Shahdad Shakeel; Phone Number: 02073777000; Email: shakeel.shahdad@nhs.net
    • Contact: Thomas Gill; Phone Number: 02073777000; Email: thomas.gill@qmul.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NGA Implant; NGA Implant (NobelActive TiUltraNP, Nobel Biocare AG, Switzerland)	Device: Implant Type; 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).
Experimental: BLX implant (BLX) modSLA Surface; BLX implant (BLX) modSLA Surface (BLX, SLActive, Roxolid, Institut Straumann AG, Switzerland)	Device: Implant Type; 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).
Experimental: TLX implant (TLX) modSLA Surface; TLX implant (TLX) modSLA Surface (TLX, SLActive, Roxolid, Institut Straumann AG, Switzerland).	Device: Implant Type; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 Year post loading

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aesthetic Outcome	- A numerical comparison of the three groups from an objective aesthetic scale derived from a panel of 2 dentists.	1 Year post loading
Patient Satisfaction	- A numerical comparison of the patient satisfaction between the three groups derived from an analysis of patient questionnaires (Likert Scales).	1 Year post loading
Patient Satisfaction- Aesthetics	- A numerical comparison of the aesthetic merit between the three groups derived from an analysis of patient questionnaires (Likert scales)	1 Year post loading
Primary Stability	A numerical comparison of primary stability measurement of the three groups (IT, RFA).	1 Year post loading
Immunological Response	- A numerical and qualitative comparison of inflammatory profiles derived from peripheral blood of the three groups	Pre-surgery to 12 Weeks post surgery

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust
• Collaborators: Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 160995; IRAS:329055 (Registry Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No