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NCT Number: NCT05576922

Collagen Matrix + rhPDGF-BB vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences

The study aims at comparing two different approaches for the treatment of implant esthetic complications (peri-implant soft tissue dehiscences): autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard School of Dental Medicine

Boston, Massachusetts, 02115, United States

About this study

The present randomized clinical trial aims at investigating two approaches (autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB) when performed in combination with the prosthetic-surgical approach for the treatment of peri-implant soft tissue dehiscences. Clinical, volumetric, ultrasonographic and patient-reported outcomes will be evaluated at different time points up to 1 year.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥ 18 years,
  • Periodontally and systemically healthy,
  • Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth), iv) Presence of single dental implant in the anterior area (from the first right premolar to the first left premolar) showing a PSTD, with the subjects searching for treatment of this condition,
  • Peri-implant papillae not flat (PSTD subclass a or b) (Zucchelli et al., 2019), vi) Implants diagnosed as healthy (Berglundh et al., 2018),
  • Ability to perform good oral hygiene

Exclusion criteria

  • Contraindications for surgery,
  • Systemic condition (e.g. diabetes mellitus, HIV, cancer, etc) that could compromise wound healing,
  • Patients pregnant or attempting to get pregnant (self-reported),
  • Untreated periodontitis,
  • Untreated peri-implant mucositis or peri-implantitis (Berglundh et al., 2018),
  • Smoking, defined as self-reported daily habit. Occasional smokers won't be excluded,
  • History of soft tissue grafting at the implant site showing PSTD within the last 6 months.

Indications for surgical intervention will be established based on patient's esthetic demands and peri-implant soft tissue phenotype.

Treatment and study plan

Prosthetic-surgical approach + autogenous graft

Other

Coronally advanced flap with an autogenous graft (CTG)

Prosthetic-surgical approach + graft substitute

Other

Coronally advanced flap with a graft substitute (collagen matrix and rhPDGF-BB)

Primary outcomes

  1. Soft tissue dehiscence reduction

    Time frame: 6 and 12 months

    Reduction of the depth of the Soft tissue dehiscence (vertical measurement of the complication, in relation to the level of the cemento-enamel junction of the contralateral homologous tooth) compared to baseline (expressed in millimeters)

Secondary outcomes

  1. Complete peri-implant soft tissue dehiscence (PSTD) coverage

    Time frame: 6 and 12 months

    Percentage of cases with complete resolution of the implant esthetic complication (expressed as a percentage)

  2. mean peri-implant soft tissue dehiscence (PSTD) coverage

    Time frame: 6 and 12 months

    Percentage of coverage of the soft tissue dehiscence compared to baseline, measured with a formula considering final PSTD depth and initial PSTD depth (expressed as a percentage)

  3. Mucosal thickness changes

    Time frame: 3, 6 and 12 months

    Changes within the mucosal thickness measured with ultrasonography (expressed in mm)

  4. 3D Volumetric changes

    Time frame: 3, 6 and 12 months

    Changes within the buccal contour measured by superimposing digital impressions obtained with optical scanning (expressed in mm^3)

  5. Post-operative pain

    Time frame: 14 days after the surgery

    Patient-reported pain after the surgical procedure (expressed with a 0-10 visual analogue scale [VAS])

  6. Professional esthetic assessment

    Time frame: 12 months

    Esthetic outcomes of the treatment assessed by a calibrated operator using the Implant soft tissue Dehiscence coverage Esthetic Score (IDES) (expressed using points, based on the IDES classification system from Zucchelli et al. 2021)

Sponsors and collaborators

Lead sponsor

Harvard Medical School (HMS and HSDM)

Other

Registry information

Official study title

Xenogeneic Collagen Matrix Loaded With rhPDGF-BB vs Autogenous Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences: A Randomized, Controlled, Clinical, Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 13, 2022
Registry last updated
Apr 10, 2025

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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