Dental ImplantsNCT07324187
CTG vs VCMX for Peri-implant Soft Tissue Thickness
A study testing Connective Tissue Graft and Volume-Stable Collagen Matrix in people with Dental Implants and Peri-Implant Tissues, run by Medical Innovation Center Wroclaw at 1 site in Poland.
Trial summary
This investigator-initiated randomized controlled clinical trial evaluated changes in peri-implant soft tissue thickness in the aesthetic zone following soft tissue augmentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants, Peri-Implant Tissues, Missing Tooth/Teeth
- What is being tested?
- Connective Tissue Graft and Volume-Stable Collagen Matrix
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePoland
- Study dates
- 2 Jan 2022to 19 Apr 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Single-tooth edentulism in the aesthetic zone of the maxilla or mandible, bordered by natural teeth on both sides.
- Bilateral two-tooth edentulism accepted only when implants were placed in separate quadrants.
- Indication for dental implant placement with peri-implant soft tissue augmentation.
- Adequate bone volume at the implant site confirmed radiographically.
- Baseline peri-implant soft tissue thickness suitable for augmentation.
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- Minimum height of keratinized tissue of at least 2 mm.
- Good oral hygiene and periodontal health.
- Ability and willingness to provide written informed consent.
Who cannot join
- Previous bone grafting procedures at the intended implant site.
- Severe periodontal disease or untreated oral infection.
- Bruxism or heavy smoking.
- Systemic diseases or conditions that could impair wound healing or bone metabolism.
- History of radiotherapy in the head and neck region.
- Previous or ongoing bisphosphonate therapy.
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- Uncontrolled diabetes mellitus.
- Pregnancy or breastfeeding.
- Use of medications known to interfere with soft tissue healing.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medyczne Centrum Innowacji Wrocław (Wrocław Medical Innovation Center), formerly operating as Akademicka Akademicka Poliklinika Stomatologiczna
Wroclaw
About this study
Official title: Peri-implant Soft Tissue Thickness in the Aesthetic Zone: A Randomized Controlled Clinical Trial Comparing Connective Tissue Grafts and a Volume-Stable Collagen Matrix
This investigator-initiated randomized controlled clinical trial evaluated changes in peri-implant soft tissue thickness in the aesthetic zone following soft tissue augmentation. Adult patients requiring single-tooth implant therapy in the aesthetic zone were randomly assigned to receive either an autogenous connective tissue graft (CTG) or a volume-stable collagen matrix (VCMX) at the implant site.
The primary objective of the study was to compare changes in peri-implant soft tissue thickness between the two treatment approaches over time. Secondary objectives included evaluation of aesthetic outcomes, clinical parameters, and treatment-related complications.
The study was conducted at a single academic clinical center in Poland in accordance with Good Clinical Practice, the Declaration of Helsinki, and applicable ethical and regulatory requirements. All participants provided written informed consent prior to enrollment.
Read the detailed description
This investigator-initiated, single-center, randomized controlled clinical trial was designed to assess the effectiveness of two different soft tissue augmentation approaches on peri-implant soft tissue thickness in the aesthetic zone. The study compared the use of an autogenous connective tissue graft (CTG) with a volume-stable collagen matrix (VCMX) in patients undergoing single-tooth implant therapy.
Eligible adult patients presenting with an indication for peri-implant soft tissue augmentation in the aesthetic zone were enrolled and randomly allocated in a 1:1 ratio to one of the two intervention groups. In the CTG group, a subepithelial connective tissue graft was harvested from the palate and placed at the peri-implant site. In the VCMX group, a commercially available volume-stable collagen matrix was used for soft tissue augmentation according to the manufacturer's instructions.
Standardized surgical and prosthetic protocols were applied in both groups. Clinical examinations and outcome assessments were performed at predefined follow-up visits. The primary outcome measure was the change in peri-implant soft tissue thickness measured at the implant site over time. Secondary outcome measures included additional clinical parameters, aesthetic outcomes, patient-reported outcomes, and the incidence of adverse events or complications.
The study protocol, patient information sheet, and informed consent form were approved by the Bioethics Committee of Wroclaw Medical University prior to study initiation. The study was conducted in compliance with Good Clinical Practice guidelines, ISO 14155, and the principles of the Declaration of Helsinki. All participants provided written informed consent before any study-related procedures were performed.
- Conditions
- Dental Implants, Peri-Implant Tissues, Missing Tooth/Teeth
- Being tested
- Connective Tissue Graft, Volume-Stable Collagen Matrix
- Keywords
- connective tissue graft,, collagen matrix, peri-implant soft tissue, CTG, VCMX
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective Tissue GraftProcedure or surgery
An autogenous subepithelial connective tissue graft harvested from the palatal donor site and used for peri-implant soft tissue augmentation according to a standardized surgical protocol.
Volume-Stable Collagen MatrixDevice
A volume-stable collagen matrix used for peri-implant soft tissue augmentation according to the manufacturer's instructions and a standardized surgical protocol.
| Study group | Role | What they receive |
|---|---|---|
| Connective Tissue Graft (CTG) | Active comparator | Participants received peri-implant soft tissue augmentation using an autogenous subepithelial connective tissue graft harvested from the palate and placed at the implant site according to a standardized surgical protocol. Receives: Procedure: Connective Tissue Graft |
| Volume-Stable Collagen Matrix (VCMX) | Experimental | Participants received peri-implant soft tissue augmentation using a volume-stable collagen matrix placed at the implant site according to the manufacturer's instructions and a standardized surgical protocol. Receives: Device: Volume-Stable 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
Change in peri-implant soft tissue thickness measured at the implant site using a standardized clinical measurement method.
Measured: Baseline and 6 months after soft tissue augmentation
Secondary outcomes (1)
Peri-implant soft tissue thickness at additional follow-up time points
Peri-implant soft tissue thickness assessed at predefined follow-up visits after soft tissue augmentation.
Measured: Baseline, 3 months, and 12 months after augmentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start2 Jan 2022
- Primary completion10 Apr 2025
- Study completion19 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Participants were randomly assigned in a 1:1 ratio to one of two parallel intervention groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Innovation Center Wroclaw
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Principal investigator, Jakub Hadzik, Medical Innovation Center Wroclaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324187
- Sponsor's protocol ID
- 400166
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to data protection and confidentiality considerations, and because informed consent for public data sharing was not obtained from participants.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-implant Soft Tissue Thickness in the Aesthetic Zone: A Randomized Controlled Clinical Trial Comparing Connective Tissue Grafts and a Volume-Stable Collagen Matrix
- ClinicalTrials.gov ID
- NCT07324187
- Acronym / sponsor ID
- 400166
- Conditions
- Dental Implants, Peri-Implant Tissues, Missing Tooth/Teeth
- Keywords
- connective tissue graft,, collagen matrix, peri-implant soft tissue, CTG, VCMX
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medical Innovation Center WroclawUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 19 Apr 2025 (actual)
- First posted
- 7 Jan 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.
This investigator-initiated randomized controlled clinical trial evaluated changes in peri-implant soft tissue thickness in the aesthetic zone following soft tissue augmentation. Adult patients requiring single-tooth implant therapy in the aesthetic zone were randomly assigned to receive either an autogenous connective tissue graft (CTG) or a volume-stable collagen matrix (VCMX) at the implant site.
The primary objective of the study was to compare changes in peri-implant soft tissue thickness between the two treatment approaches over time. Secondary objectives included evaluation of aesthetic outcomes, clinical parameters, and treatment-related complications.
The study was conducted at a single academic clinical center in Poland in accordance with Good Clinical Practice, the Declaration of Helsinki, and applicable ethical and regulatory requirements. All participants provided written informed consent prior to enrollment.
Detailed description
This investigator-initiated, single-center, randomized controlled clinical trial was designed to assess the effectiveness of two different soft tissue augmentation approaches on peri-implant soft tissue thickness in the aesthetic zone. The study compared the use of an autogenous connective tissue graft (CTG) with a volume-stable collagen matrix (VCMX) in patients undergoing single-tooth implant therapy.
Eligible adult patients presenting with an indication for peri-implant soft tissue augmentation in the aesthetic zone were enrolled and randomly allocated in a 1:1 ratio to one of the two intervention groups. In the CTG group, a subepithelial connective tissue graft was harvested from the palate and placed at the peri-implant site. In the VCMX group, a commercially available volume-stable collagen matrix was used for soft tissue augmentation according to the manufacturer's instructions.
Standardized surgical and prosthetic protocols were applied in both groups. Clinical examinations and outcome assessments were performed at predefined follow-up visits. The primary outcome measure was the change in peri-implant soft tissue thickness measured at the implant site over time. Secondary outcome measures included additional clinical parameters, aesthetic outcomes, patient-reported outcomes, and the incidence of adverse events or complications.
The study protocol, patient information sheet, and informed consent form were approved by the Bioethics Committee of Wroclaw Medical University prior to study initiation. The study was conducted in compliance with Good Clinical Practice guidelines, ISO 14155, and the principles of the Declaration of Helsinki. All participants provided written informed consent before any study-related procedures were performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Connective Tissue Graft (CTG) | Active comparator | Procedure: Connective Tissue GraftParticipants received peri-implant soft tissue augmentation using an autogenous subepithelial connective tissue graft harvested from the palate and placed at the implant site according to a standardized surgical protocol. |
| Volume-Stable Collagen Matrix (VCMX) | Experimental | Device: Volume-Stable Collagen MatrixParticipants received peri-implant soft tissue augmentation using a volume-stable collagen matrix placed at the implant site according to the manufacturer's instructions and a standardized surgical protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults aged 18 years or older.
- Single-tooth edentulism in the aesthetic zone of the maxilla or mandible, bordered by natural teeth on both sides.
- Bilateral two-tooth edentulism accepted only when implants were placed in separate quadrants.
- Indication for dental implant placement with peri-implant soft tissue augmentation.
- Adequate bone volume at the implant site confirmed radiographically.
Key exclusion criteria (9 listed)
- Previous bone grafting procedures at the intended implant site.
- Severe periodontal disease or untreated oral infection.
- Bruxism or heavy smoking.
- Systemic diseases or conditions that could impair wound healing or bone metabolism.
- History of radiotherapy in the head and neck region.
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 GraftAn autogenous subepithelial connective tissue graft harvested from the palatal donor site and used for peri-implant soft tissue augmentation according to a standardized surgical protocol. | Procedure or surgery | Connective Tissue Graft (CTG) |
| Volume-Stable Collagen MatrixA volume-stable collagen matrix used for peri-implant soft tissue augmentation according to the manufacturer's instructions and a standardized surgical protocol. | Device | Volume-Stable Collagen Matrix (VCMX) |
Primary outcome
Change in peri-implant soft tissue thickness
Time frame: Baseline and 6 months after soft tissue augmentation
Change in peri-implant soft tissue thickness measured at the implant site using a standardized clinical measurement method.
1 secondary outcome
Peri-implant soft tissue thickness at additional follow-up time points
Time frame: Baseline, 3 months, and 12 months after augmentation
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 16 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to data protection and confidentiality considerations, and because informed consent for public data sharing was not obtained from participants.
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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 and Volume-Stable Collagen Matrix in people with Dental Implants and Peri-Implant Tissues, run by Medical Innovation Center Wroclaw at 1 site in Poland.
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 9 inclusion and 9 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 16 Jan 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 Poland. 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 (time frame: Baseline and 6 months after soft tissue augmentation). 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 16 Jan 2026; AzTrials last refreshed its copy on 2 Nov 2026.