Implant Placement Depth and Peri-Implant Tissue Outcomes

Condition(s) studied

Investigational drug(s) / intervention(s)

Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol: Participants will receive bone-level dental implants placed subcrestally at either -2 mm or -4 mm below the bone crest in healed posterior sites of the maxilla or mandible, according to randomization. Implant placement will follow the manufacturer's drilling protocol, achieving a final insertion torque of at least 35 Ncm. A transmucosal abutment will be connected at the time of surgery, with height selected based on implant placement depth (2-3 mm for -2 mm placement and 4-5 mm for -4 mm placement). The abutment will be tightened to a final torque of at least 30 Ncm following a one abutment-one time protocol.

Study summary

The primary aim of this randomized clinical trial is to evaluate the influence of subcrestal implant placement depth (-2 mm vs -4 mm) on peri-implant marginal bone level changes, including marginal bone loss and bone remodeling. Secondary outcomes include implant success, peri-implant probing depth (PPD), and bleeding on probing (BoP).

Partially edentulous patients requiring fixed implant-supported prosthetic rehabilitation with two implants in posterior maxillary or mandibular regions will be included. Implants will be placed subcrestally at either -2 mm or -4 mm from the bone crest, following a submerged healing protocol. Allocation to insertion depth will be randomized. Marginal bone level changes will be assessed using standardized periapical radiographs at second-stage surgery, prosthesis placement, and at 1, 3, 6, and 12 months after functional loading. PPD and BoP will be recorded at the same time points.

Eligibility

Primary outcome measure(s)

• Changes in peri-implant marginal bone level (mm) — From abutment placement (baseline time [TB]), 1 month post (T1), and at 3 (T3) (prosthetic loading) , 6 (T6), and 12 (T12) months after definitive prosthesis placement.
  Parallelized periapical radiographs will be obtained and a calibrated digital tool will be used to determine the vertical distance from the implant-abutment junction to the most coronal bone-to-implant contact on the mesial and distal sides. Unit of measure: Milimeters (mm)

Trial sites (1)

More University of Valencia trials in Spain

Other trials for the same condition