MedTrace Logo

Implant Placement Depth and Peri-Implant Tissue Outcomes

NCT07535528 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-17

No results posted yet for this 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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University of Valencia

    lead OTHER

Principal Investigators

  • Ana Verónica Blanco Besteiro, DDS, MSc and PhD candidate · University of Valencia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2026-11-20
Completion
2027-07-20

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07535528 on ClinicalTrials.gov