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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Root coverage procedures | Procedure | Treatment of multiple adjacent gingival recession using a coronally advanced flap |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Angiogenic Biomarkers | Within-subject difference between the concentrations at the control and test sites | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Dentistry | Ann Arbor | Michigan | 48104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39843351 | Derived | 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. | |
| 35871600 | Derived | 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. |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| 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 |
| D055093 |
| Periodontal Atrophy |