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Completed

NCT Number: NCT07501715

Peri-implant Soft Tissue Changes at Small Buccal Dehiscences

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

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Key information

Conditions

Dental Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

C.I.R. Dental School

Torino, 10126, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

connective tissue graft

Procedure

Following implant placement, a connective tissue graft (CTG) will be harvested from the patient's palate using a standardized technique. The graft will be trimmed and adapted to the buccal aspect of the implant site and stabilized with sutures to increase peri-implant soft tissue thickness. Flap management will be performed to ensure passive adaptation and primary closure. Healing abutments will be placed.

horizontal guided bone regeneration

Procedure

Following implant placement, guided bone regeneration (GBR) will be performed at the buccal aspect of the implant using a xenogeneic bone substitute to fill the dehiscence defect. The graft material will be covered with a resorbable collagen membrane, which will be stabilized to ensure defect containment. Flap advancement will be performed to obtain tension-free primary closure. Healing abutments will be placed according to the study protocol.

Primary outcomes

  1. Buccal soft tissue contour change (profilometric analysis)

    Time frame: 12 months after prosthetic loading

    Change in buccal soft tissue contour assessed by profilometric analysis through superimposition of digital surface scans (intraoral scans). Linear and/or volumetric changes at the buccal aspect of the implant site will be quantified using dedicated software.

Secondary outcomes

  1. Marginal Bone Level (MBL) change

    Time frame: 12 months after prosthetic loading

    Change in marginal bone levels measured on standardized periapical radiographs using customized holders. Measurements will be taken from the implant shoulder to the first bone-to-implant contact.

  2. Mucosal thickness gain

    Time frame: 12 months after prosthetic loading

    Peri-implant mucosal thickness measured at the mid-buccal aspect using a standardized superimposition software.

  3. Width of keratinized mucosa

    Time frame: 12 months after prosthetic loading

    Width of keratinized mucosa measured from the mucogingival junction to the free gingival margin at the mid-buccal aspect.

  4. Pink Esthetic Score

    Time frame: 12 months after prosthetic loading

    Esthetic evaluation using the Pink Esthetic Score (PES) assessed from standardized photographs by blinded examiners.

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Peri-implant Soft Tissue Volume Changes After Treatment of Small Buccal Dehiscence With Connective Tissue Graft or Guided Bone Regeneration: a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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