NCT07535528

Implant Placement Depth and Peri-Implant Tissue Outcomes

Influence of Implant Placement Depth (-2 mm vs -4 mm Subcrestal) on Peri-implant Tissue Conditions: a Randomized Clinical Trial Protocol

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Valencia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Implant Placement
• Soft Tissue Management in Subcrestal Dental Implants
• Marginal Bone Loss

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2026-05-15
• Primary completion: 2026-11-20
• Completion: 2027-07-20
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: Spain