NCT05576922

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 4, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2025

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

2.8 years

First QC Date

October 3, 2022

Last Update Submit

April 8, 2025

Conditions

Implant Complication

Outcome Measures

Primary Outcomes (1)

  • Soft tissue dehiscence reduction

    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 Outcomes (6)

  • Complete peri-implant soft tissue dehiscence (PSTD) coverage

    6 and 12 months

  • mean peri-implant soft tissue dehiscence (PSTD) coverage

    6 and 12 months

  • Mucosal thickness changes

    3, 6 and 12 months

  • 3D Volumetric changes

    3, 6 and 12 months

  • Post-operative pain

    14 days after the surgery

  • +1 more secondary outcomes

Study Arms (2)

Connective tissue graft

ACTIVE COMPARATOR

Autogenous connective tissue graft harvested from the palate as a free gingival graft and then de-epithelialized

Other: Prosthetic-surgical approach + autogenous graft

Collagen matrix + rhPDGF-BB

EXPERIMENTAL

Xenogeneic cross-linked collagen matrix + recombinant human platelet-derived growth factor-BB

Other: Prosthetic-surgical approach + graft substitute

Interventions

Prosthetic-surgical approach + autogenous graftOTHER

Coronally advanced flap with an autogenous graft (CTG)

Connective tissue graft
Prosthetic-surgical approach + graft substituteOTHER

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

Collagen matrix + rhPDGF-BB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard School of Dental Medicine

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Transplantation, Autologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Officials

  • Lorenzo Tavelli, DDS, MS

    Harvard School of Dental Medicine, Boston, USA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel-arm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 13, 2022

Study Start

January 4, 2023

Primary Completion

October 20, 2025

Study Completion

October 21, 2025

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)