CompletedNot Applicable

Peri-implant Soft Tissue Changes at Small Buccal Dehiscences

Italy44 participantsStarted 2023-09-05

Plain-language summary

This study was designed to assess peri-implant soft tissue health, volume and marginal stability at implants sites which presented small buccal bone dehiscences (\<3mm evaluated in a vertical direction) at the time of insertion. Patients will be then randomly allocated to receive grafting with connective tissue graft or guided bone regeneration and evaluated at 3 months after surgery and at 12 months of follow up after crown placement

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults ≥18 years of age * Patients requiring a single dental implant in a healed site in the posterior region (premolar or molar areas) * Presence of a buccal bone dehiscence defect at implant placement, defined as a vertical defect of the buccal bone plate ≥1 mm and ≤3 mm measured from the implant shoulder after implant insertion * Adequate residual bone to allow implant placement with primary stability (insertion torque ≥25 Ncm or ISQ ≥60) * Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤20% * Patients able to understand and sign informed consent * Patients willing to comply with study procedures and follow-up visits Exclusion Criteria: * Uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus, HbA1c \>7.5%) * Immunocompromised patients * History of radiotherapy in the head and neck region * Use of medications affecting bone metabolism (e.g., bisphosphonates, denosumab) * Pregnancy or lactation

What they're measuring

Buccal soft tissue contour change (profilometric analysis)

Timeframe: 12 months after prosthetic loading

Trial details

NCT IDNCT07501715

SponsorUniversity of Turin, Italy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-01