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

NCT06408506 | Completed

• 1 other identifier: 29-172 ex 16/17
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Immediate loading; Prei-implant bone regeneration; Implant Survival

Outcome Measures

Primary Outcomes (1)

• Survival

  Implant survival

  24 months

Secondary Outcomes (6)

• Peri-implant bone height

  0 and 4 months

• Oral Health Impact Profile-14 in German

  0 to 24 months

• Bleeding on Probing

  0 to 24 months

• Plaque Index

  0 to 24 months

• Probing Around Implants

  0 to 24 months

Study Arms (1)

6 Implants in edentulous mandible

OTHER

Placement of 6 Implants in the lower jaw, Two of which are remained to heal submucosal, two transmucosal, and two by immediate loading with removable gold bar retained dentures

Procedure: Re-Entry Surgery; Procedure: Probing peri-implant bone; Procedure: Scanning peri-implant bone; Procedure: Conventional Impressions; Procedure: Implant Surgery; Procedure: Healing procedure

Interventions

Re-Entry Surgery PROCEDURE

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

6 Implants in edentulous mandible

Probing peri-implant bone PROCEDURE

Probing peri-implant bone with Dental Probe during surgery

6 Implants in edentulous mandible

Scanning peri-implant bone PROCEDURE

Scanning peri-implant bone during surgery

6 Implants in edentulous mandible

Conventional Impressions PROCEDURE

Conventional Impressions during surgery

6 Implants in edentulous mandible

Implant Surgery PROCEDURE

Placement of 6 implants in the edentulous mandible

6 Implants in edentulous mandible

Healing procedure 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

6 Implants in edentulous mandible

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written consent of the participant after being informed Capability of giving an informed consent

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Dental Department Medical University of Graz

Graz, Styria, 8010, Austria

Location

Related Publications (5)

• Lorenzoni M, Pertl C, Zhang K, Wegscheider WA. In-patient comparison of immediately loaded and non-loaded implants within 6 months. Clin Oral Implants Res. 2003 Jun;14(3):273-9. doi: 10.1034/j.1600-0501.2003.140304.x.

  PMID: 12755777 BACKGROUND

• Ericsson I, Randow K, Nilner K, Peterson A. Early functional loading of Branemark dental implants: 5-year clinical follow-up study. Clin Implant Dent Relat Res. 2000;2(2):70-7. doi: 10.1111/j.1708-8208.2000.tb00108.x.

  PMID: 11359266 BACKGROUND

• Siddiqui AA, Ismail JY, Kukunas S. Immediate loading of dental implants in the edentulous mandible: a preliminary case report from an international prospective multicenter study. Compend Contin Educ Dent. 2001 Oct;22(10):867-70, 873-4, 876 passim; quiz 884.

  PMID: 11915636 BACKGROUND

• Schulte W, Lukas D. Periotest to monitor osseointegration and to check the occlusion in oral implantology. J Oral Implantol. 1993;19(1):23-32.

  PMID: 8246291 BACKGROUND

• Sokolowski A, Lorenzoni M, Steyer E, Marschner F, Pichler A, Sokolowski A. In-patient comparison of marginal bone loss after 4 months in immediately loaded, submucosal, and transmucosal dental implants using 3D scanning: a prospective clinical trial. Clin Oral Investig. 2025 Mar 17;29(4):186. doi: 10.1007/s00784-025-06255-y.

  PMID: 40095138 DERIVED

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Alwin Sokolowski, DDS,MDS,PhD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The positioning and loading protocols of the implants under investigation are blinded to the investigator during the analysis of peri-implant bone heights, which are measured using periodontal probes, as well as during the analysis of intraoperative scans and impressions.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 10, 2024
• Study Start: September 28, 2017
• Primary Completion: October 29, 2025
• Study Completion: October 29, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)