Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLA

Launched by BARTS & THE LONDON NHS TRUST · Oct 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two types of dental implants to see how well they integrate with the bone in the jaw after a year. The researchers want to understand not only the stability of the bone around the implants but also how they look, how the body reacts to them, and the overall satisfaction of patients who receive them. The implants being tested are called modSLA and NGA.

To participate in this study, you should be over 18 years old and need to have a tooth removed due to decay or other issues. You should also be healthy enough to follow the study's guidelines and give your consent. However, certain health conditions, like uncontrolled diabetes or diseases affecting bone, may prevent you from joining. If you qualify, you can expect to receive the dental implant and be monitored for a year, during which the team will check on your healing, satisfaction, and any side effects. This trial is currently looking for participants, and it could provide valuable information about dental implants to help future patients.

Gender

ALL

Eligibility 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.