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 range

20 Years – 80 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Survival

Timeframe: 24 months

Trial details

NCT IDNCT06408506

SponsorMedical University of Graz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-29

View on ClinicalTrials.gov More Jaw, Edentulous trials