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

April 8, 2025 updated by: Lorenzo Tavelli, Harvard Medical School (HMS and HSDM)

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Harvard School of Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Connective tissue graft
Autogenous connective tissue graft harvested from the palate as a free gingival graft and then de-epithelialized
Other: Prosthetic-surgical approach + autogenous graft
Coronally advanced flap with an autogenous graft (CTG)
Experimental: Collagen matrix + rhPDGF-BB
Xenogeneic cross-linked collagen matrix + recombinant human platelet-derived growth factor-BB
Other: Prosthetic-surgical approach + graft substitute
Coronally advanced flap with a graft substitute (collagen matrix and rhPDGF-BB)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
6 and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
6 and 12 months
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)
6 and 12 months
Mucosal thickness changes
Time Frame: 3, 6 and 12 months
Changes within the mucosal thickness measured with ultrasonography (expressed in mm)
3, 6 and 12 months
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)
3, 6 and 12 months
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])
14 days after the surgery
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)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harvard Medical School (HMS and HSDM)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lorenzo Tavelli, DDS, MS, Harvard School of Dental Medicine, Boston, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 21, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Delta IMPL REC (IRB22-0637)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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