NCT04462237

Brief Summary

The present randomized clinical trial is aimed at evaluating the efficacy of recombinant human platelet-derived growth factor in combination with collagen matrix for the treatment of multiple adjacent gingival recessions

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 9, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

June 29, 2020

Last Update Submit

September 26, 2021

Conditions

Gingival RecessionPlatelet Derived Growth Factor

Outcome Measures

Primary Outcomes (3)

  • Mean Root Coverage

    amount of recession reduction compared to the baseline recession depth

    6 months

  • Keratinized tissue width gain

    amount of keratinized tissue width gain from the baseline

    6 months

  • Gingival thickness gain

    amount of gingival thickness gain from the baseline

    6 months

Secondary Outcomes (4)

  • 3D volumetric changes

    6 months

  • Tissue perfusion variations

    6 months

  • Patient-related outcomes

    6 months

  • Esthetic outcomes

    6 months

Other Outcomes (1)

  • Differences in Angiogenic Biomarkers

    3 months

Study Arms (2)

collagen matrix + platelet-derived growth factor

EXPERIMENTAL

Root coverage procedure using collagen matrix + platelet-derived growth factor for the treatment of multiple adjacent gingival recessions

Procedure: Root coverage procedures

collagen matrix alone

ACTIVE COMPARATOR

Root coverage procedure using collagen matrix alone (without the use of the platelet-derived growth factor) for the treatment of multiple adjacent gingival recessions

Procedure: Root coverage procedures

Interventions

Root coverage proceduresPROCEDURE

Treatment of multiple adjacent gingival recession using a coronally advanced flap

collagen matrix + platelet-derived growth factorcollagen matrix alone

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)
  • At least two multiple adjacent gingival recessions (with at least one 2 mm or deeper) requiring surgical intervention for root coverage
  • No interproximal attachment/bone loss
  • No prior experience of root coverage procedures within the last 1 year
  • The patient must be able to perform good oral hygiene

You may not qualify if:

  • Contraindications for periodontal surgery
  • Patients pregnant or attempting to get pregnant (self-reported)
  • Untreated periodontitis
  • Persistence of uncorrected gingival trauma from traumatic toothbrushing
  • Interdental attachment loss greater than 1 mm or furcation involvement in the teeth to be treated
  • Presence of severe tooth malposition, rotation or clinically significant super-eruption
  • Self-reported current smoking more than 10 cigarettes/day or pipe or cigar smoking
  • Allergy to collagen-based medical products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48104, United States

Location

Related Publications (2)

  • Tavelli L, Nguyen T, Rodriguez MV, Mancini L, Giannobile WV, Barootchi S. Tissue Perfusion and Biomarkers Assessment Following Root Coverage Procedures. J Periodontal Res. 2025 Nov;60(11):1117-1131. doi: 10.1111/jre.13374. Epub 2025 Jan 22.

    PMID: 39843351DERIVED

  • Tavelli L, Barootchi S, Rodriguez MV, Mancini L, Majzoub J, Travan S, Sugai J, Chan HL, Kripfgans O, Wang HL, Giannobile WV. Recombinant human platelet-derived growth factor improves root coverage of a collagen matrix for multiple adjacent gingival recessions: A triple-blinded, randomized, placebo-controlled trial. J Clin Periodontol. 2022 Nov;49(11):1169-1184. doi: 10.1111/jcpe.13706. Epub 2022 Jul 31.

    PMID: 35871600DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Lorenzo Tavelli, DDS, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • William Giannobile, DDS, MS, DMSc

    University of Michigan

    STUDY CHAIR

  • Hom-Lay Wang, DDS, MS, PhD

    University of Michigan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 8, 2020

Study Start

September 9, 2020

Primary Completion

August 18, 2021

Study Completion

August 18, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)