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

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.

Conditions

• Jaw, Edentulous

Interventions

PROCEDURE

Re-Entry Surgery

Re-entry surgery 4 months after the insertion of the implants to reveal implants after osseointegration

PROCEDURE

Probing peri-implant bone

Probing peri-implant bone with Dental Probe during surgery

PROCEDURE

Scanning peri-implant bone

Scanning peri-implant bone during surgery

PROCEDURE

Conventional Impressions

Conventional Impressions during surgery

PROCEDURE

Implant Surgery

Placement of 6 implants in the edentulous mandible

PROCEDURE

Healing procedure

All 6 Implants in all patients are let to heal for 4 Months under the same conditions: The most distal implants are left submerged. The most mesial implants are left transgingival and the Implants in the middle are immediately loaded using gold bar retained dentures

Sponsors & Collaborators

• Medical University of Graz

  lead OTHER

Principal Investigators

• Alwin Sokolowski, DDS,MDS,PhD · Medical University of Graz

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-09-28

Primary Completion

2025-10-29

Completion

2025-10-29

Countries

• Austria

Study Locations