Status:
RECRUITING
Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLA
Lead Sponsor:
Barts & The London NHS Trust
Collaborating Sponsors:
Virginia Commonwealth University
Conditions:
Dental Implant
Eligibility:
All Genders
18+ years
Phase:
NA
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 patien...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT06086873
Start Date
April 11 2024
End Date
January 1 2027
Last Update
March 26 2025
Active Locations (1)
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1
Royal London Dental Institute
London, United Kingdom, E1 1BB