Comparative Evaluation Between One-piece and Two-piece Implants Supporting Mandibular Screw-retained All-On-Four Full-arch Prosthesis on Peri-implant Bone Changes.

ConditionsMarginal Bone Loss One-piece Implants Versus Two-piece Implants During the Osseointegration Phase

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorCairo University

About this trial

Evaluating the bone changing after receiving one-piece implants supported full arch prosthesis compared to the conventional two-piece implants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Completely edentulous patients, who can sign an informed consent will be considered eligible for this trial.

Residual bone height should have sufficient volume and quality for implant placement with a minimum of 12-14 mm in height and 6 mm in width.

Patients who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, technical problems concerning denture design and/or occlusion are found, or who are dissatisfied with the retention and stability of their technically satisfactory mandibular dentures.

Disqualifiers

- Patients with conditions that may contraindicate implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino bisphosphonates, patients undergoing radiotherapy to the head and neck region).

Inadequate mouth opening

Heavy smokers, more than 10 cigarettes/day

Patients with poor oral hygiene and motivation.

Trial design

Design model

Parallel

Treatments tested in this trial

One-piece dental implants with MUA
Device
one-piece dental implants with multi-units abutment mounted on the implants as a single piece provided with different abutment angulation utilizing these implants for All-On-Four prothesis
Two-piece dental implants
Device
Surgical and immediate loading procedures: On the day of implant placement, patients will receive two-piece implant. After crestal incision and full-thickness flap elevation, the implant sites will be prepared aided by a surgical template. 4 implants will be placed, two aligned in an axial orientation and two will be distally aligned (17 degrees). The standard placement procedure as recommended by the manufacturer will be used. The surgical drills with increasing diameters will be used to prepare the implant sites. Implants will be ideally placed at bone level (or 1 mm deeper depending on the soft tissue thickness). After 3 months as a healing phase, a definitive prosthesis will be fabricated using the same abutments, and the marginal bone loss after the osseointegration phase will be assessed.

Treatment groups

22 Participants

are divided into 2 treatment groups

Group A: Patients will receive an implant screw-retained restoration supported by One-piece implants.Experimental treatment 1 intervention

Group B: Patients will receive an implant screw-retained restoration supported by two-piece implants.Active comparator 1 intervention

Trial outcomes

Primary outcomes

Peri-implant marginal bone loss

Peri-implant marginal bone loss will be assessed utilizing CBCT. The radiographic evaluation will be performed at baseline and at 3 months after functional loading. Using the first thread of the implant as a standard reference point, the circumference of the Crestal bone level around the implant will be measured in all directions (mesial, distal, buccal, and lingual) in width and height.

Time frame

From implant placement (baseline) and After 3 months (after the osseointegration phase)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: