Comparing two types of dental implants for bone stability and aesthetics
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 is testing which type of dental implant surface, NGA or modSLA, works better for keeping the bone stable and looking good after a tooth extraction in the front of the mouth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Barts & The London NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06086873 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of two different dental implant surfaces, NGA and modSLA, on the stability of crestal bone levels and aesthetic outcomes one year after loading. It will recruit 39 patients requiring a single tooth extraction in the anterior maxilla and randomly assign them to receive either an NGA implant or one of two modSLA implants. The study will assess various outcomes, including immunological responses and patient-reported measures, to determine the best implant surface for dental restoration. This research aims to fill a gap in existing literature regarding the comparative effectiveness of these implant surfaces.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who require extraction of a single-rooted anterior tooth in the maxilla.
Not a fit: Patients with systemic diseases affecting bone metabolism or those requiring multiple extractions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dental implant outcomes, enhancing both bone stability and aesthetic results for patients.
How similar studies have performed: While ultra-hydrophilic implants have been studied extensively, this specific comparison between NGA and modSLA surfaces is novel and has not been previously published.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
London
- Royal London Dental Institute — London, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.