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

Gingival Recession Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04462237
• Other study ID #: HUM00177214
• Status: Completed
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: August 18, 2021

Study information

• Verified date: September 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 18, 2021
• Est. primary completion date: August 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Platelet Derived Growth Factor

Intervention

Procedure:
• Root coverage procedures
Treatment of multiple adjacent gingival recession using a coronally advanced flap

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences in Angiogenic Biomarkers	Within-subject difference between the concentrations at the control and test sites	3 months
Primary	Mean Root Coverage	amount of recession reduction compared to the baseline recession depth	6 months
Primary	Keratinized tissue width gain	amount of keratinized tissue width gain from the baseline	6 months
Primary	Gingival thickness gain	amount of gingival thickness gain from the baseline	6 months
Secondary	3D volumetric changes	Soft tissue volumetric variation evaluated with digital softwares	6 months
Secondary	Tissue perfusion variations	Tissue perfusion variations compared to baseline at the different follow-up using ultrasonography	6 months
Secondary	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
Secondary	Esthetic outcomes	evaluated using the root coverage esthetic score (from 0 to 10)	6 months