In-patient Comparison of Immediately Loaded and Non-loaded Submerged and Transgingival Healed Implants Within 4 Months - Trial NCT06408506

Timeline & Enrollment

Primary Outcome

Survival

Summary

The study involves 20 patients who require implant treatment for the edentulous lower jaw,
 following specific inclusion and exclusion criteria. Patients are drawn from the regular pool
 of those seeking implant therapy, with no additional recruitment efforts.
 
 This study compares the effects of loaded and non-loaded dental implants. Preoperative
 assessments include medical histories, clinical, and radiographic examinations of the jaw.
 Participants are thoroughly informed about the study procedures and consent to participate
 through signed agreements. They undergo preoperative diagnostics, including panoramic X-rays
 to evaluate mandibular bone height, and complete the OHIP-G 14 questionnaire to establish a
 baseline for their oral health-related quality of life.
 
 The implant placement involves standard outpatient surgical procedures under local
 anesthesia. The implants used are CE-certified and are placed in predetermined positions in
 the edentulous region. During the surgery intraoral scans and conventional impressions are
 performed. Post-operative care includes oral rinses, and radiographic assessments, with
 follow-up visits scheduled for suture removal and further assessments using the visual analog
 scale for pain and swelling.
 
 The healing phase spans four months, during which patients' comfort and oral health are
 monitored through clinical examinations and additional questionnaires. Follow-up after 4
 months includes re-entry surgery and further radiographic evaluations and intraoral scans to
 assess the bone's response around the implants. Throughout the study, adverse events and
 patient satisfaction are continuously documented.
 
 In the later stages, regular follow-up visits for up to 24 months post-surgery to monitor
 implant stability and health through clinical and radiographic check-ups are performed.
 
 This study aims to document implant survival rates, peri-implant bone regeneration, assess
 biological and technical complications, and evaluate patient satisfaction and quality of life
 throughout the implant process, providing valuable data for future dental implant protocols.

ICD-10 Classifications