Implant ComplicationNCT05576922
Collagen Matrix + rhPDGF-BB vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences
A study testing Prosthetic-surgical approach + autogenous graft and Prosthetic-surgical approach + graft substitute in people with Implant Complication, run by Harvard Medical School (HMS and HSDM) at 1 site in United States.
Trial summary
The study aims at comparing two different approaches for the treatment of implant esthetic complications (peri-implant soft tissue dehiscences): autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Complication
- What is being tested?
- Prosthetic-surgical approach + autogenous graft and Prosthetic-surgical approach + graft substitute
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2023to 21 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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), iv) Presence of single dental implant in the anterior area (from the first right premolar to the first left premolar) showing a PSTD, with the subjects searching for treatment of this condition,
- Peri-implant papillae not flat (PSTD subclass a or b) (Zucchelli et al., 2019), vi) Implants diagnosed as healthy (Berglundh et al., 2018),
- Ability to perform good oral hygiene
Who cannot join
- Contraindications for surgery,
- Systemic condition (e.g. diabetes mellitus, HIV, cancer, etc) that could compromise wound healing,
- Patients pregnant or attempting to get pregnant (self-reported),
- Untreated periodontitis,
- Untreated peri-implant mucositis or peri-implantitis (Berglundh et al., 2018),
- Smoking, defined as self-reported daily habit. Occasional smokers won't be excluded,
- History of soft tissue grafting at the implant site showing PSTD within the last 6 months.
- Indications for surgical intervention will be established based on patient's esthetic demands and peri-implant soft tissue phenotype.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard School of Dental Medicine
Boston, Massachusetts, 02115
About this study
Official title: Xenogeneic Collagen Matrix Loaded With rhPDGF-BB vs Autogenous Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences: A Randomized, Controlled, Clinical, Trial
The study aims at comparing two different approaches for the treatment of implant esthetic complications (peri-implant soft tissue dehiscences): autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB
Read the detailed description
The present randomized clinical trial aims at investigating two approaches (autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB) when performed in combination with the prosthetic-surgical approach for the treatment of peri-implant soft tissue dehiscences. Clinical, volumetric, ultrasonographic and patient-reported outcomes will be evaluated at different time points up to 1 year.
- Conditions
- Implant Complication
- Being tested
- Prosthetic-surgical approach + autogenous graft, Prosthetic-surgical approach + graft substitute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic-surgical approach + autogenous graftOther
Coronally advanced flap with an autogenous graft (CTG)
Prosthetic-surgical approach + graft substituteOther
Coronally advanced flap with a graft substitute (collagen matrix and rhPDGF-BB)
| Study group | Role | What they receive |
|---|---|---|
| Connective tissue graft | Active comparator | Autogenous connective tissue graft harvested from the palate as a free gingival graft and then de-epithelialized Receives: Other: Prosthetic-surgical approach + autogenous graft |
| Collagen matrix + rhPDGF-BB | Experimental | Xenogeneic cross-linked collagen matrix + recombinant human platelet-derived growth factor-BB Receives: Other: Prosthetic-surgical approach + graft substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue dehiscence reduction
Reduction of the depth of the Soft tissue dehiscence (vertical measurement of the complication, in relation to the level of the cemento-enamel junction of the contralateral homologous tooth) compared to baseline (expressed in millimeters)
Measured: 6 and 12 months
Secondary outcomes (6)
Complete peri-implant soft tissue dehiscence (PSTD) coverage
Percentage of cases with complete resolution of the implant esthetic complication (expressed as a percentage)
Measured: 6 and 12 months
mean peri-implant soft tissue dehiscence (PSTD) coverage
Percentage of coverage of the soft tissue dehiscence compared to baseline, measured with a formula considering final PSTD depth and initial PSTD depth (expressed as a percentage)
Measured: 6 and 12 months
Mucosal thickness changes
Changes within the mucosal thickness measured with ultrasonography (expressed in mm)
Measured: 3, 6 and 12 months
3D Volumetric changes
Changes within the buccal contour measured by superimposing digital impressions obtained with optical scanning (expressed in mm^3)
Measured: 3, 6 and 12 months
Post-operative pain
Patient-reported pain after the surgical procedure (expressed with a 0-10 visual analogue scale [VAS])
Measured: 14 days after the surgery
Professional esthetic assessment
Esthetic outcomes of the treatment assessed by a calibrated operator using the Implant soft tissue Dehiscence coverage Esthetic Score (IDES) (expressed using points, based on the IDES classification system from Zucchelli et al. 2021)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start4 Jan 2023
- Primary completion20 Oct 2025 (estimated)
- Study completion21 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant ComplicationStudies of the same condition, open and under way.
- 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
- Model description
- Parallel-arm
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Tavelli, Harvard Medical School (HMS and HSDM)
- Investigators
- Lorenzo Tavelli, DDS, MS, Principal investigator, Harvard School of Dental Medicine, Boston, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576922
- Sponsor's protocol ID
- Delta IMPL REC (IRB22-0637)
- Status last verified
- Apr 2025
- First submitted
- 3 Oct 2022
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xenogeneic Collagen Matrix Loaded With rhPDGF-BB vs Autogenous Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences: A Randomized, Controlled, Clinical, Trial
- ClinicalTrials.gov ID
- NCT05576922
- Acronym / sponsor ID
- Delta IMPL REC (IRB22-0637)
- Conditions
- Implant Complication
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 21 Oct 2025 (estimated)
- First posted
- 13 Oct 2022 (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 study aims at comparing two different approaches for the treatment of implant esthetic complications (peri-implant soft tissue dehiscences): autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB
Detailed description
The present randomized clinical trial aims at investigating two approaches (autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB) when performed in combination with the prosthetic-surgical approach for the treatment of peri-implant soft tissue dehiscences. Clinical, volumetric, ultrasonographic and patient-reported outcomes will be evaluated at different time points up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-arm
| Arm | Type | Receives |
|---|---|---|
| Connective tissue graft | Active comparator | Other: Prosthetic-surgical approach + autogenous graftAutogenous connective tissue graft harvested from the palate as a free gingival graft and then de-epithelialized |
| Collagen matrix + rhPDGF-BB | Experimental | Other: Prosthetic-surgical approach + graft substituteXenogeneic cross-linked collagen matrix + recombinant human platelet-derived growth factor-BB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years,
- Periodontally and systemically healthy,
- Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth), iv) Presence of single dental implant in the anterior area (from the first right premolar to the first left premolar) showing a PSTD, with the subjects searching for treatment of this condition,
- Peri-implant papillae not flat (PSTD subclass a or b) (Zucchelli et al., 2019), vi) Implants diagnosed as healthy (Berglundh et al., 2018),
- Ability to perform good oral hygiene
Key exclusion criteria (8 listed)
- Contraindications for surgery,
- Systemic condition (e.g. diabetes mellitus, HIV, cancer, etc) that could compromise wound healing,
- Patients pregnant or attempting to get pregnant (self-reported),
- Untreated periodontitis,
- Untreated peri-implant mucositis or peri-implantitis (Berglundh et al., 2018),
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 |
|---|---|---|
| Prosthetic-surgical approach + autogenous graftCoronally advanced flap with an autogenous graft (CTG) | Other | Connective tissue graft |
| Prosthetic-surgical approach + graft substituteCoronally advanced flap with a graft substitute (collagen matrix and rhPDGF-BB) | Other | Collagen matrix + rhPDGF-BB |
Primary outcome
Soft tissue dehiscence reduction
Time frame: 6 and 12 months
Reduction of the depth of the Soft tissue dehiscence (vertical measurement of the complication, in relation to the level of the cemento-enamel junction of the contralateral homologous tooth) compared to baseline (expressed in millimeters)
6 secondary outcomes
Complete peri-implant soft tissue dehiscence (PSTD) coverage
Time frame: 6 and 12 months
mean peri-implant soft tissue dehiscence (PSTD) coverage
Time frame: 6 and 12 months
Mucosal thickness changes
Time frame: 3, 6 and 12 months
3D Volumetric changes
Time frame: 3, 6 and 12 months
Post-operative pain
Time frame: 14 days after the surgery
Professional esthetic assessment
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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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
Harvard School of Dental Medicine, Boston, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic-surgical approach + autogenous graft and Prosthetic-surgical approach + graft substitute in people with Implant Complication, run by Harvard Medical School (HMS and HSDM) 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 5 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: under way, not looking for participants, as of the sponsor's last update on 10 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Soft tissue dehiscence reduction (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2025.