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NCT Number: NCT05729607

Vertical Soft Tissue Augmentation With CTG vs ADM

The study aims at comparing two different approaches for vertical soft tissue augmentation at implant sites exhibiting soft tissue dehiscences: autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard School of Dental Medicine

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Lorenzo Tavelli, DDS, MS

CONTACT

[email protected]

7346044364

About this study

The present randomized clinical trial aims at investigating two approaches (autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative) when performed for vertical soft tissue augmentation at sites with 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)
  • Presence of single functional dental implant in the anterior with a PSTD
  • Implants diagnosed as healthy (Berglundh et al., 2018)

Exclusion criteria

are:

  • 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 within the last 6 months

Treatment and study plan

Vertical soft tissue augmentation

Procedure

Vertical soft tissue augmentation with autogenous connective tissue graft (CTG)

Primary outcomes

  1. Change in Soft tissue dehiscence depth

    Time frame: 12 months

    Change 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) at 12 months compared to baseline (expressed in millimeters)

Secondary outcomes

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

    Time frame: 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: 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 (IDES)

    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) The range is from 0 (worst outcome) to 10 (best outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Lorenzo Tavelli, DDS, MS

CONTACT

[email protected]

734-604-4364

Sponsors and collaborators

Lead sponsor

Harvard Medical School (HMS and HSDM)

Other

Registry information

Official study title

Vertical Soft Tissue Augmentation With Dermal Matrix and Enamel Matrix Derivative vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences in the Esthetic Zone: A Randomized, Controlled, Clinical, Trial

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 15, 2023
Registry last updated
Sep 18, 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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