Gingival RecessionNCT04462237
Recombinant Human Platelet-derived Growth Factor in Combination With Collagen Matrix
A study testing Root coverage procedures in people with Gingival Recession and Platelet Derived Growth Factor, run by University of Michigan at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Platelet Derived Growth Factor
- What is being tested?
- Root coverage procedures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2020to 18 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48104
About this study
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
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
Read the 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.
- Conditions
- Gingival Recession, Platelet Derived Growth Factor
- Being tested
- Root coverage procedures
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root coverage proceduresProcedure or surgery
Treatment of multiple adjacent gingival recession using a coronally advanced flap
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Root coverage procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Root Coverage
amount of recession reduction compared to the baseline recession depth
Measured: 6 months
Keratinized tissue width gain
amount of keratinized tissue width gain from the baseline
Measured: 6 months
Gingival thickness gain
amount of gingival thickness gain from the baseline
Measured: 6 months
Secondary outcomes (4)
3D volumetric changes
Soft tissue volumetric variation evaluated with digital softwares
Measured: 6 months
Tissue perfusion variations
Tissue perfusion variations compared to baseline at the different follow-up using ultrasonography
Measured: 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
Measured: 6 months
Esthetic outcomes
evaluated using the root coverage esthetic score (from 0 to 10)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start9 Sep 2020
- Primary completion18 Aug 2021
- Study completion18 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Tavelli, University of Michigan
- Investigators
- Lorenzo Tavelli, DDS, MS, Principal investigator, University of MichiganWilliam Giannobile, DDS, MS, DMSc, Study chair, University of MichiganHom-Lay Wang, DDS, MS, PhD, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462237
- Sponsor's protocol ID
- HUM00177214
- Status last verified
- Sep 2021
- First submitted
- 29 Jun 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39843351Tavelli 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.
PubMed 35871600
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04462237
- Acronym / sponsor ID
- HUM00177214
- Conditions
- Gingival Recession, Platelet Derived Growth Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| collagen matrix + platelet-derived growth factor | Experimental | Procedure: Root coverage proceduresRoot coverage procedure using collagen matrix + platelet-derived growth factor for the treatment of multiple adjacent gingival recessions |
| collagen matrix alone | Active comparator | Procedure: Root coverage proceduresRoot coverage procedure using collagen matrix alone (without the use of the platelet-derived growth factor) for the treatment of multiple adjacent gingival recessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Root coverage proceduresTreatment of multiple adjacent gingival recession using a coronally advanced flap | Procedure or surgery | collagen matrix + platelet-derived growth factor, collagen matrix alone |
Primary outcome
Mean Root Coverage
Time frame: 6 months
amount of recession reduction compared to the baseline recession depth
Keratinized tissue width gain
Time frame: 6 months
amount of keratinized tissue width gain from the baseline
Gingival thickness gain
Time frame: 6 months
amount of gingival thickness gain from the baseline
4 secondary outcomes
3D volumetric changes
Time frame: 6 months
Tissue perfusion variations
Time frame: 6 months
Patient-related outcomes
Time frame: 6 months
Esthetic outcomes
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 39843351Tavelli 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.
- Derived from this study: PubMed 35871600Tavelli 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.
- Individual participant dataSharing planned: No
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Gingival Recession
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Tavelli, DDS, MS principal investigator
University of Michigan
William Giannobile, DDS, MS, DMSc study chair
University of Michigan
Hom-Lay Wang, DDS, MS, PhD study director
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root coverage procedures in people with Gingival Recession and Platelet Derived Growth Factor, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Root Coverage (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04462237, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.