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

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

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

Study Overview

• Status: Completed
• Conditions: Gingival Recession; Platelet Derived Growth Factor
• Intervention / Treatment: Procedure: Root coverage procedures

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • University of Michigan School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: collagen matrix + platelet-derived growth factor; Root coverage procedure using collagen matrix + platelet-derived growth factor for the treatment of multiple adjacent gingival recessions	Procedure: Root coverage procedures; Treatment of multiple adjacent gingival recession using a coronally advanced flap
ACTIVE_COMPARATOR: collagen matrix alone; 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; Treatment of multiple adjacent gingival recession using a coronally advanced flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D volumetric changes	Soft tissue volumetric variation evaluated with digital softwares	6 months
Tissue perfusion variations	Tissue perfusion variations compared to baseline at the different follow-up using ultrasonography	6 months
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	6 months
Esthetic outcomes	evaluated using the root coverage esthetic score (from 0 to 10)	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in Angiogenic Biomarkers	Within-subject difference between the concentrations at the control and test sites	3 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Lorenzo Tavelli, DDS, MS, University of Michigan; Study Chair: William Giannobile, DDS, MS, DMSc, University of Michigan; Study Director: Hom-Lay Wang, DDS, MS, PhD, University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2020
• Primary Completion (ACTUAL): August 18, 2021
• Study Completion (ACTUAL): August 18, 2021

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (ACTUAL): July 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 26, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: HUM00177214

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