Peri-implant Soft Tissue AugmentationNCT07605286
Soft Tissue Augmentation Around Dental Implants
A study testing Connective Tissue Graft (Palate), Connective Tissue Graft (Tuberosity) and Fibro-Gide Collagen Matrix in people with Peri-implant Soft Tissue Augmentation and Dental Implant Rehabilitation, run by Andrey Vasilyev at 1 site in Russia.
Trial summary
The goal of this study is to determine which method better increases the volume of soft tissues (gums) around dental implants: using the patient's own tissues or applying collagen matrices. The study also evaluates the safety of these methods and their impact on smile aesthetics. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Peri-implant Soft Tissue Augmentation, Dental Implant Rehabilitation
- What is being tested?
- Connective Tissue Graft (Palate), Connective Tissue Graft (Tuberosity) and Fibro-Gide Collagen Matrix
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2021to 1 Oct 2024
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 21 and 75 years
- Requirement for single dental implant placement in the mandibular molar region (replacing no more than one tooth)
- Need for soft tissue augmentation to achieve peri-implant mucosal thickness ≥2 mm
- Signed voluntary informed consent for treatment and research participation
- Ability and willingness to attend all scheduled follow-up examinations for 12 months post-surgery
- Adequate oral hygiene and commitment to maintain it throughout the study period
Who cannot join
- Presence of systemic diseases in a decompensated stage (e.g., uncontrolled diabetes, severe cardiovascular disease)
- Current or prior use of immunosuppressants, bisphosphonates, or high-dose corticosteroids
- History of cancer, radiation therapy, or chemotherapy within 5 years prior to enrollment
- Need for concurrent bone grafting or immediate implant placement following tooth extraction
- Active periodontal disease or untreated oral infections at the time of surgery
- Heavy smoking (>10 cigarettes/day) or inability to abstain from smoking during the healing period
Show all 11Show fewer
- Pregnancy or lactation
- Known allergy to collagen, porcine/bovine products, or materials used in the study (sutures, anesthetics)
- Participation in another clinical trial within 30 days prior to enrollment
- Refusal to participate in any stage of the study or inability to comply with study procedures
- Psychological or social conditions that, in the investigator's judgment, may compromise protocol adherence or data reliability
Trial locations and contacts
1 site in 1 country.
Russia1 site
Central Research Institute of Dental and Maxillofacial Surgery
Moscow, 119021
About this study
Official title: The Use of Collagen Matrices and Connective Tissue Grafts for Soft Tissue Augmentation Around Dental Implants
The goal of this study is to determine which method better increases the volume of soft tissues (gums) around dental implants: using the patient's own tissues or applying collagen matrices. The study also evaluates the safety of these methods and their impact on smile aesthetics.
The main questions it aims to answer:
Read more
Which method provides greater and more stable increase in gum thickness around the implant? Does the choice of material affect gum color (how well it matches adjacent areas)? What features of healing and cellular tissue structure are observed when using different materials?
Researchers will compare:
Autogenous connective tissue grafts (CTG) - the patient's own connective tissue grafts harvested from the palate or maxillary tuberosity Xenogeneic collagen matrices (XCM) - bioresorbable materials of animal origin (Fibro-Gide® and FibroMatrix®) that do not require harvesting the patient's own tissue
Participants will:
Undergo a surgical procedure to increase soft tissue volume in the area of implant placement (using one of four methods assigned randomly)
Attend clinic visits for follow-up examinations and assessments:
- Before surgery
- 3 months after surgery
- 6 months after surgery
Undergo additional examinations:
- 3D intraoral scanning to assess changes in tissue volume
- Cone-beam computed tomography (CBCT) to measure gum thickness
- Polarized-light photography to evaluate gum color
- Collection of a small tissue sample (biopsy) for laboratory analysis of tissue structure and cellular composition
- Being tested
- Connective Tissue Graft (Palate), Connective Tissue Graft (Tuberosity), Fibro-Gide Collagen Matrix, FibroMatrix Collagen Matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective Tissue Graft (Palate)Procedure or surgery
Autogenous subepithelial connective tissue graft harvested from the hard palate (premolar-molar region) using a horizontal incision 2-3 mm apical to the gingival margin. Epithelium removed microscopically. Graft secured within a soft-tissue "envelope" at the recipient implant site using U-shaped sutures. Donor site closed with compression sutures.
Connective Tissue Graft (Tuberosity)Procedure or surgery
Autogenous subepithelial connective tissue graft harvested from the maxillary tuberosity using parallel incisions 2 mm distal to the last molar. Epithelial strip removed. Graft placed and secured at the implant site using U-shaped suturing technique. Donor site closed with interrupted sutures.
Fibro-Gide Collagen MatrixDevice
Porcine-derived xenogeneic collagen matrix (types I/III), 6 mm thick, gamma-sterilized. Trimmed to fit recipient site, placed between flap and bone without suturing to the flap, fully covered by soft tissues during closure. No donor site required.
FibroMatrix Collagen MatrixDevice
Bovine pericardium-derived xenogeneic collagen matrix (types I/III), 3-4 mm thick, freeze-dried, bilayer structure. Trimmed to fit recipient site, placed between flap and bone without suturing to the flap, fully covered by soft tissues during closure. No donor site required.
| Study group | Role | What they receive |
|---|---|---|
| Palate CTG | Experimental | Subepithelial connective tissue graft harvested from the hard palate, placed at the implant site to augment soft tissue thickness and volume Receives: Procedure: Connective Tissue Graft (Palate) |
| Tuberosity CTG | Experimental | Subepithelial connective tissue graft harvested from the maxillary tuberosity, placed at the implant site to augment soft tissue thickness and volume Receives: Procedure: Connective Tissue Graft (Tuberosity) |
| Fibro-Gide | Experimental | Xenogeneic collagen matrix (porcine-derived, types I/III collagen), trimmed and placed between the flap and bone to augment soft tissue Receives: Device: Fibro-Gide Collagen Matrix |
| FibroMatrix | Experimental | Xenogeneic collagen matrix (bovine pericardium-derived, types I/III collagen), trimmed and placed between the flap and bone to augment soft tissue Receives: Device: FibroMatrix Collagen Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peri-implant soft tissue thickness from baseline to 6 months post-augmentation
The primary outcome is the mean change in vertical soft tissue thickness at the implant site, measured at three equidistant points (crest, 1 mm apical, 2 mm apical) along the vestibular aspect of the alveolar ridge. Thickness is assessed using three complementary methods: (1) mucosal puncture with a calibrated spreader and silicone stopper under local anesthesia; (2) superimposition of cone-beam computed tomography (CBCT) scans; and (3) comparison of digital 3D intraoral scans (STL files) using GOM Inspect software. Measurements are averaged across the three points per site. The primary analysis compares mean thickness gain between the four intervention groups (palate CTG, tuberosity CTG, Fibro-Gide, FibroMatrix) at 6 months.
Measured: Baseline (pre-surgery), 3 months post-surgery, and 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Oct 2021
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant Soft Tissue AugmentationStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrey Vasilyev
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Andrey Vasilyev, Research Centre for Medical Genetics, Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605286
- Sponsor's protocol ID
- 1/20
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly. This decision is based on: (1) the single-center, academic nature of the study with a relatively small sample size, which increases re-identification risk even after de-identification; (2) the inclusion of detailed clinical, radiographic, and histological data that may contain sensitive personal health information; (3) ongoing secondary analyses and manuscript preparations by the investigative team; and (4) the absence of a dedicated infrastructure for secure, governed data sharing at this institution.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Collagen Matrices and Connective Tissue Grafts for Soft Tissue Augmentation Around Dental Implants
- ClinicalTrials.gov ID
- NCT07605286
- Acronym / sponsor ID
- 1/20
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Andrey VasilyevOther government
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 22 May 2026 (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 goal of this study is to determine which method better increases the volume of soft tissues (gums) around dental implants: using the patient's own tissues or applying collagen matrices. The study also evaluates the safety of these methods and their impact on smile aesthetics.
The main questions it aims to answer:
Which method provides greater and more stable increase in gum thickness around the implant? Does the choice of material affect gum color (how well it matches adjacent areas)? What features of healing and cellular tissue structure are observed when using different materials?
Researchers will compare:
Autogenous connective tissue grafts (CTG) - the patient's own connective tissue grafts harvested from the palate or maxillary tuberosity Xenogeneic collagen matrices (XCM) - bioresorbable materials of animal origin (Fibro-Gide® and FibroMatrix®) that do not require harvesting the patient's own tissue
Participants will:
Undergo a surgical procedure to increase soft tissue volume in the area of implant placement (using one of four methods assigned randomly)
Attend clinic visits for follow-up examinations and assessments:
- Before surgery
- 3 months after surgery
- 6 months after surgery
Undergo additional examinations:
- 3D intraoral scanning to assess changes in tissue volume
- Cone-beam computed tomography (CBCT) to measure gum thickness
- Polarized-light photography to evaluate gum color
- Collection of a small tissue sample (biopsy) for laboratory analysis of tissue structure and cellular composition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Palate CTG | Experimental | Procedure: Connective Tissue Graft (Palate)Subepithelial connective tissue graft harvested from the hard palate, placed at the implant site to augment soft tissue thickness and volume |
| Tuberosity CTG | Experimental | Procedure: Connective Tissue Graft (Tuberosity)Subepithelial connective tissue graft harvested from the maxillary tuberosity, placed at the implant site to augment soft tissue thickness and volume |
| Fibro-Gide | Experimental | Device: Fibro-Gide Collagen MatrixXenogeneic collagen matrix (porcine-derived, types I/III collagen), trimmed and placed between the flap and bone to augment soft tissue |
| FibroMatrix | Experimental | Device: FibroMatrix Collagen MatrixXenogeneic collagen matrix (bovine pericardium-derived, types I/III collagen), trimmed and placed between the flap and bone to augment soft tissue |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 21 and 75 years
- Requirement for single dental implant placement in the mandibular molar region (replacing no more than one tooth)
- Need for soft tissue augmentation to achieve peri-implant mucosal thickness ≥2 mm
- Signed voluntary informed consent for treatment and research participation
- Ability and willingness to attend all scheduled follow-up examinations for 12 months post-surgery
Key exclusion criteria (11 listed)
- Presence of systemic diseases in a decompensated stage (e.g., uncontrolled diabetes, severe cardiovascular disease)
- Current or prior use of immunosuppressants, bisphosphonates, or high-dose corticosteroids
- History of cancer, radiation therapy, or chemotherapy within 5 years prior to enrollment
- Need for concurrent bone grafting or immediate implant placement following tooth extraction
- Active periodontal disease or untreated oral infections at the time of surgery
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 |
|---|---|---|
| Connective Tissue Graft (Palate)Autogenous subepithelial connective tissue graft harvested from the hard palate (premolar-molar region) using a horizontal incision 2-3 mm apical to the gingival margin. Epithelium removed microscopically. Graft secured within a soft-tissue "envelope" at the recipient implant site using U-shaped sutures. Donor site closed with compression sutures. | Procedure or surgery | Palate CTG |
| Connective Tissue Graft (Tuberosity)Autogenous subepithelial connective tissue graft harvested from the maxillary tuberosity using parallel incisions 2 mm distal to the last molar. Epithelial strip removed. Graft placed and secured at the implant site using U-shaped suturing technique. Donor site closed with interrupted sutures. | Procedure or surgery | Tuberosity CTG |
| Fibro-Gide Collagen MatrixPorcine-derived xenogeneic collagen matrix (types I/III), 6 mm thick, gamma-sterilized. Trimmed to fit recipient site, placed between flap and bone without suturing to the flap, fully covered by soft tissues during closure. No donor site required. | Device | Fibro-Gide |
| FibroMatrix Collagen MatrixBovine pericardium-derived xenogeneic collagen matrix (types I/III), 3-4 mm thick, freeze-dried, bilayer structure. Trimmed to fit recipient site, placed between flap and bone without suturing to the flap, fully covered by soft tissues during closure. No donor site required. | Device | FibroMatrix |
Primary outcome
Change in peri-implant soft tissue thickness from baseline to 6 months post-augmentation
Time frame: Baseline (pre-surgery), 3 months post-surgery, and 6 months post-surgery
The primary outcome is the mean change in vertical soft tissue thickness at the implant site, measured at three equidistant points (crest, 1 mm apical, 2 mm apical) along the vestibular aspect of the alveolar ridge. Thickness is assessed using three complementary methods: (1) mucosal puncture with a calibrated spreader and silicone stopper under local anesthesia; (2) superimposition of cone-beam computed tomography (CBCT) scans; and (3) comparison of digital 3D intraoral scans (STL files) using GOM Inspect software. Measurements are averaged across the three points per site. The primary analysis compares mean thickness gain between the four intervention groups (palate CTG, tuberosity CTG, Fibro-Gide, FibroMatrix) at 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 22 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly. This decision is based on: (1) the single-center, academic nature of the study with a relatively small sample size, which increases re-identification risk even after de-identification; (2) the inclusion of detailed clinical, radiographic, and histological data that may contain sensitive personal health information; (3) ongoing secondary analyses and manuscript preparations by the investigative team; and (4) the absence of a dedicated infrastructure for secure, governed data sharing at this institution.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective Tissue Graft (Palate), Connective Tissue Graft (Tuberosity) and Fibro-Gide Collagen Matrix in people with Peri-implant Soft Tissue Augmentation and Dental Implant Rehabilitation, run by Andrey Vasilyev at 1 site in Russia.
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 6 inclusion and 11 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 22 May 2026. 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 Russia. 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?
Change in peri-implant soft tissue thickness from baseline to 6 months post-augmentation (time frame: Baseline (pre-surgery), 3 months post-surgery, and 6 months post-surgery). 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 22 May 2026.