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Recombinant Human Platelet-derived Growth Factor in Combination With Collagen Matrix

Primary Purpose

Gingival Recession, Platelet Derived Growth Factor

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Root coverage procedures
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)
  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Michigan School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

collagen matrix + platelet-derived growth factor

collagen matrix alone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean Root Coverage
amount of recession reduction compared to the baseline recession depth
Keratinized tissue width gain
amount of keratinized tissue width gain from the baseline
Gingival thickness gain
amount of gingival thickness gain from the baseline

Secondary Outcome Measures

3D volumetric changes
Soft tissue volumetric variation evaluated with digital softwares
Tissue perfusion variations
Tissue perfusion variations compared to baseline at the different follow-up using ultrasonography
Patient-related outcomes
Patient self reported perception of the procedure in terms of morbidity, satisfaction and esthetic outcomes. Visual analogue scales (from 0 to 100) will be used to assess these outcomes
Esthetic outcomes
evaluated using the root coverage esthetic score (from 0 to 10)

Full Information

First Posted
June 29, 2020
Last Updated
September 26, 2021
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04462237
Brief Title
Recombinant Human Platelet-derived Growth Factor in Combination With Collagen Matrix
Official Title
The Effect of Recombinant Human Platelet-derived Growth Factor in Combination With Collagen Matrix for the Treatment of Multiple Adjacent Gingival Recessions: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
August 18, 2021 (Actual)
Study Completion Date
August 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Despite the fact that gingival recession is most often a generalized condition rather than being localized to a single tooth, most of the data currently found in the literature pertains to the treatment of localized gingival recessions. The gold standard treatment for this condition involves the use of an autogenous connective tissue graft, that is associated with increased patient morbidity. Biomaterials have progressively gained popularity due to their advantages when compared to autogenous grafts, such as unrestricted availability, avoidance of a secondary surgical site, reduction of the surgical time, and the patient's preference. Collagen matrix is one of the most used soft tissue substitute for the treatment of gingival recessions. Combining this scaffold material with a growth factor could enhance its outcomes. In particular, root coverage using platelet-derived growth factor can also promote regeneration of new cementum, periodontal ligament and bone. Therefore, the aim of the present study is to investigate the effect of platelet-derived growth factor in combination with collagen matrix outcomes for the treatment of multiple adjacent gingival recessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Platelet Derived Growth Factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
collagen matrix + platelet-derived growth factor
Arm Type
Experimental
Arm Description
Root coverage procedure using collagen matrix + platelet-derived growth factor for the treatment of multiple adjacent gingival recessions
Arm Title
collagen matrix alone
Arm Type
Active Comparator
Arm Description
Root coverage procedure using collagen matrix alone (without the use of the platelet-derived growth factor) for the treatment of multiple adjacent gingival recessions
Intervention Type
Procedure
Intervention Name(s)
Root coverage procedures
Intervention Description
Treatment of multiple adjacent gingival recession using a coronally advanced flap
Primary Outcome Measure Information:
Title
Mean Root Coverage
Description
amount of recession reduction compared to the baseline recession depth
Time Frame
6 months
Title
Keratinized tissue width gain
Description
amount of keratinized tissue width gain from the baseline
Time Frame
6 months
Title
Gingival thickness gain
Description
amount of gingival thickness gain from the baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
3D volumetric changes
Description
Soft tissue volumetric variation evaluated with digital softwares
Time Frame
6 months
Title
Tissue perfusion variations
Description
Tissue perfusion variations compared to baseline at the different follow-up using ultrasonography
Time Frame
6 months
Title
Patient-related outcomes
Description
Patient self reported perception of the procedure in terms of morbidity, satisfaction and esthetic outcomes. Visual analogue scales (from 0 to 100) will be used to assess these outcomes
Time Frame
6 months
Title
Esthetic outcomes
Description
evaluated using the root coverage esthetic score (from 0 to 10)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Differences in Angiogenic Biomarkers
Description
Within-subject difference between the concentrations at the control and test sites
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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) 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenzo Tavelli, DDS, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Giannobile, DDS, MS, DMSc
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hom-Lay Wang, DDS, MS, PhD
Organizational Affiliation
University of Michigan
Official's Role
Study Director
Facility Information:
Facility Name
University of Michigan School of Dentistry
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35871600
Citation
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.
Results Reference
derived

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Recombinant Human Platelet-derived Growth Factor in Combination With Collagen Matrix

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