Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLA

NCT06086873 | Recruiting

• 2 other identifiers: 160995IRAS:329055
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Implant

Outcome Measures

Primary Outcomes (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).

  1 Year post loading

Secondary Outcomes (5)

• Aesthetic Outcome

  1 Year post loading

• Patient Satisfaction

  1 Year post loading

• Patient Satisfaction- Aesthetics

  1 Year post loading

• Primary Stability

  1 Year post loading

• Immunological Response

  Pre-surgery to 12 Weeks post surgery

Study Arms (3)

NGA Implant

EXPERIMENTAL

NGA Implant (NobelActive TiUltraNP, Nobel Biocare AG, Switzerland)

Device: Implant Type

BLX implant (BLX) modSLA Surface

EXPERIMENTAL

BLX implant (BLX) modSLA Surface (BLX, SLActive, Roxolid, Institut Straumann AG, Switzerland)

Device: Implant Type

TLX implant (TLX) modSLA Surface

EXPERIMENTAL

TLX implant (TLX) modSLA Surface (TLX, SLActive, Roxolid, Institut Straumann AG, Switzerland).

Device: Implant Type

Interventions

Implant Type DEVICE

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).

BLX implant (BLX) modSLA Surface; NGA Implant; TLX implant (TLX) modSLA Surface

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Systemic disease that can interfere with dental implant therapy (e.g. uncontrolled diabetes)
• 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;

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Virginia Commonwealth University: collaborator

Study Sites (1)

Royal London Dental Institute

London, E1 1BB, United Kingdom

RECRUITING

Study Design

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

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: September 5, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)