CompletedNot Applicable

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

Austria20 participantsStarted 2017-09-28

Plain-language 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.

Who can participate

Age range20 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written consent of the participant after being informed Capability of giving an informed consent * good health as defined by the subjects medical history (no contraindications as described in the exclusion criteria below) * age 20 to 80 years * Patients who require 6 implants in the positions 32, 33, 34, 42, 43, 44 * edentulous mandible with enough interforaminal bone volume for placement of 6 implants * Residual vertical bone height of at least 8mm in the interforaminal region * Patients who wish implant-supported restoration with six implants Exclusion Criteria: * Homelessness * Smoking * Medication with a contraindication for implant therapy * Skeletal immaturity * Any active malignancy or ongoing treatment for malignancy * An active infection at the operative site * Persistent compartment syndrome or neurovascular residua of compartment syndrome * Pathological fractures such as those observed in (but not limited to) Paget's disease or in metastatic bone * Contraindications to the class of devices under study, e.g. known hypersensitivity or allergy to class of devices * Pregnancy * Intention to become pregnant during the course of the study * Breast feeding * Lack of safe contraception

What they're measuring

Survival

Timeframe: 24 months

Trial details

NCT IDNCT06408506

SponsorMedical University of Graz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-29