Soft Tissue Augmentation Around Dental ImplantsCTNCT07436091
Porcine Derma for Soft Tissue Augmentation Around Implants
A study testing Soft tissue augmentation with Derma OsteoBiol® around dental implants. in people with Soft Tissue Augmentation Around Dental Implants, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Brief description of the study objectives The present study aims to evaluate the effectiveness of the porcine-derived collagen matrix Derma OsteoBiol® for peri-implant soft tissue augmentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Augmentation Around Dental Implants
- What is being tested?
- Soft tissue augmentation with Derma OsteoBiol® around dental implants.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2026to 30 Dec 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients must have the ability to fully understand the nature of the proposed surgery, voluntarily consent to participate and signed the Informed Consent Form before any study related procedures are performed.
- Agree with data collection and analyses.
- Males or females who are a minimum of 18 years of age or older.
- Ability to comply with study-related procedures, including maintaining good oral hygiene and attending follow-up appointments.
- Implant placement at least 6 weeks prior to enrolment.
- There must be a need for soft tissue augmentation in an implant side.
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- Implant located in the posterior areas of the maxilla or mandibula (molar or 2nd premolars).
- Basic periodontal examination (BPE) score must be less than 2.
- patients exhibiting KT width of >2 mm at the buccal aspect of the implant.
Who cannot join
- • Patients who meet any of the following exclusion criteria are not eligible for inclusion in the study.
- General contraindications for dental and/or surgical treatment, including the use of anticoagulants.
- Presence of a vertical bone dehiscence greater than 3 mm at the implant site, as assessed at the time of soft tissue augmentation surgery.
- Heavy smoking habit, defined as consuming more than 10 cigarettes per day.
- Presence of active periodontal or peri-implant disease.
- Insulin-dependent diabetes.
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- History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years.
- Women of childbearing age who are not using a highly effective method of contraception.
- Pregnancy or breastfeeding.
- Previous or current use of medication that affects mucosal healing in general, such as steroids or large doses of anti-inflammatory drugs.
- Any disease or condition affecting connective tissue metabolism, such as arterial diseases in the operating area, bone metabolic disorders, or alcohol abuse.
- Systemic diseases such as diabetes or autoimmune diseases.
- Allergy to collagen.
- Participation in an investigational device or drug clinical trial within the last 6 months.
- Inadequate oral hygiene (FMPS>25%)
- An adverse event occurred, whether or not study device related, which precluded continued treatment;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Faculdade De Medicina Dentaria da Universidade do Porto
Porto, 4200-393
About this study
Official title: Porcine Derma for Soft Tissue Augmentation Around Implants: Clinical Study
Brief description of the study objectives The present study aims to evaluate the effectiveness of the porcine-derived collagen matrix Derma OsteoBiol® for peri-implant soft tissue augmentation.
The objectives include:
Measuring changes in soft tissue thickness (in 3D) in the buccal region of the treated implants; Analyzing patient-reported outcomes (PROMs), namely pain and impact on oral health-related quality of life; Monitoring the stability of peri-implant tissues and aesthetic parameters over a 12-month period.
Read the detailed description
Description of the study methodology (including the expected completion date) This is a prospective, controlled, post-marketing clinical follow-up study (Phase IV), to be conducted at the Faculty of Dental Medicine of the University of Porto. The aim is to evaluate the effectiveness of the resorbable porcine-derived collagen matrix Derma OsteoBiol® for soft tissue augmentation around dental implants.
Fifteen adult participants, aged 18 years or older, will be included, presenting a need for augmentation of the keratinized mucosa at the buccal aspect of an implant previously placed in the posterior region of the maxilla or mandible. Participants must be able to understand the nature of the study, provide free and informed consent, comply with the procedures and visits defined in the protocol, and maintain good oral hygiene. The dental implant must have been placed at least six weeks prior to the start of the study, and the width of the buccal keratinized mucosa must be great than one millimeters.
Individuals with general contraindications to dental surgery, such as uncontrolled use of anticoagulants, or presenting vertical bone defects greater than three millimeters at the implant site, will be excluded. Additional exclusion criteria include: heavy smoking (more than ten cigarettes per day), presence of active periodontal or peri-implant disease, insulin-dependent diabetes mellitus, history of malignant neoplasia with treatment within the last five years, pregnancy or breastfeeding, lack of effective contraception in women of childbearing age, use of medications that affect soft tissue healing, systemic diseases interfering with connective tissue metabolism (such as autoimmune or arterial diseases), alcohol abuse, collagen allergy, participation in other clinical studies within the previous six months, inadequate oral hygiene (plaque index greater than 25%), or occurrence of any adverse event preventing continuation of treatment.
After inclusion, participants will undergo mucogingival surgery using the VISTA (Vestibular Incision Submucosal Tunnel Access) surgical technique. The Derma OsteoBiol® membrane will be pre-hydrated in sterile saline solution, trimmed, and positioned at the surgical site, and stabilized with monofilament sutures. The incision will be completely closed, avoiding membrane exposure.
Tissue thickness will be assessed through intraoral digital impressions and three-dimensional tissue volume analysis, with measurements performed before surgery and at 1, 3, 6, and 12 months after the intervention. These images will be superimposed using stable anatomical reference points to ensure accuracy and will be analyzed by a calibrated and independent examiner. Clinical data will also be collected throughout the study, including measurements of keratinized mucosa width, probing depth, clinical attachment level, presence of bleeding on probing, plaque index, and gingival recession. Standardized clinical photographs will be obtained at each visit for documentation of soft tissue status and aesthetic evaluation.
Patient perspective will be assessed using the Oral Health Impact Profile questionnaire (OHIP-14) and a numerical pain rating scale, applied at specific follow-up time points. The occurrence of adverse events will be continuously monitored and recorded in accordance with applicable legal and regulatory standards.
This study will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice.
- Being tested
- Soft tissue augmentation with Derma OsteoBiol® around dental implants.
- Keywords
- soft tissue, dental implants, soft tissue substitues, Tissue thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue augmentation with Derma OsteoBiol® around dental implants.Procedure or surgery
OsteoBiol® Derma collagen membranes will be hydrated in saline before surgery. Using the VISTA technique, a vertical incision apical to the site will be made under local anesthesia, avoiding papillae. A full-thickness flap will be elevated with tunneling instruments. The membrane will be trimmed to fit, placed laterally, and secured with 6/0 monofilament vertical mattress sutures. The incision will be closed with the same suture.
| Study group | Role | What they receive |
|---|---|---|
| Derma OsteoBiol® | Experimental | Not described Receives: Procedure: Soft tissue augmentation with Derma OsteoBiol® around dental implants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 3D Soft Tissue Thickness (mm)
Digital impressions will be superimposed to assess changes in 3D soft tissue thickness at the buccal aspect of treated implant sites. Measurements will be performed by an independent, calibrated examiner at baseline and at 1, 3, 6, and 12 months post-surgery, following standardized 3D model analysis protocols.
Measured: 1, 3, 6, and 12 months post-surgery
Secondary outcomes (6)
Patient-Reported Outcomes (PROs)
Oral Health Impact Profile-14 (OHIP-14): Administered at baseline (Visit 2), and at 10 days, and at 1, 3, 6, and 12 months postoperatively.
Measured: 10 days, 1, 3, 6, and 12 months
General Clinical Measurements
Clinical parameters will include keratinized tissue (KT) width, probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), plaque index (PI), and recession depth. These will be evaluated at screening, baseline, and during follow-up visits
Measured: screening (-30 to -1), baseline (day 0), Visit 3 - 10 days, Visit 4 - 1 month, Visit 5 - 3 months, Visit 6 - 6 months, Visit 7 - 12 months
Safety Monitoring
Patients will be continuously monitored for adverse events. Any device-related complaints or failures will be promptly reported to the manufacturer in accordance with regulatory requirements.
Measured: baseline (day 0), Visit 3 - 10 days, Visit 4 - 1 month, Visit 5 - 3 months, Visit 6 - 6 months, Visit 7 - 12 months
Aesthetic Outcomes
Aesthetic evaluation will include the Papilla Index (Jemt, 1997), spectrophotometric comparison of mucosal color to the contralateral site, and the Pink Esthetic Score (PES) as proposed by Fürhauser et al. (2005).
Measured: screening (-30 to -1), baseline (day 0), Visit 3 - 10 days, Visit 4 - 1 month, Visit 5 - 3 months, Visit 6 - 6 months, Visit 7 - 12 months
Clinical Photographs
Soft tissue conditions will be documented through standardized clinical photography taken at baseline, during surgery, and at follow-up visits.
Measured: screening (-30 to -1), baseline (day 0), Visit 3 - 10 days, Visit 4 - 1 month, Visit 5 - 3 months, Visit 6 - 6 months, Visit 7 - 12 months
Pain Assessment (NRS)
Pain Assessment (NRS) with the pain with the numerical rating scale. Will be employed at 10 days, 1 month, and any time the patient reports increased discomfort.
Measured: 10 days, 1 month, and any time the patient reports increased discomfort (through study completion, an average of 1 year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Apr 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Augmentation Around 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Tecnoss Dental srl
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436091
- Sponsor's protocol ID
- 27b/2025
- Acronym
- CT
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) collected during the study, including demographic characteristics, baseline clinical data, intervention details, primary and secondary outcome measures, and adverse events data. Data dictionaries describing the variables will also be made available.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Porcine Derma for Soft Tissue Augmentation Around Implants: Clinical Study
- ClinicalTrials.gov ID
- NCT07436091
- Acronym / sponsor ID
- CT / 27b/2025
- Keywords
- soft tissue, dental implants, soft tissue substitues, Tissue thickness
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Tecnoss Dental srl
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 27 Feb 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.
Brief description of the study objectives The present study aims to evaluate the effectiveness of the porcine-derived collagen matrix Derma OsteoBiol® for peri-implant soft tissue augmentation.
The objectives include:
Measuring changes in soft tissue thickness (in 3D) in the buccal region of the treated implants; Analyzing patient-reported outcomes (PROMs), namely pain and impact on oral health-related quality of life; Monitoring the stability of peri-implant tissues and aesthetic parameters over a 12-month period.
Detailed description
Description of the study methodology (including the expected completion date) This is a prospective, controlled, post-marketing clinical follow-up study (Phase IV), to be conducted at the Faculty of Dental Medicine of the University of Porto. The aim is to evaluate the effectiveness of the resorbable porcine-derived collagen matrix Derma OsteoBiol® for soft tissue augmentation around dental implants.
Fifteen adult participants, aged 18 years or older, will be included, presenting a need for augmentation of the keratinized mucosa at the buccal aspect of an implant previously placed in the posterior region of the maxilla or mandible. Participants must be able to understand the nature of the study, provide free and informed consent, comply with the procedures and visits defined in the protocol, and maintain good oral hygiene. The dental implant must have been placed at least six weeks prior to the start of the study, and the width of the buccal keratinized mucosa must be great than one millimeters.
Individuals with general contraindications to dental surgery, such as uncontrolled use of anticoagulants, or presenting vertical bone defects greater than three millimeters at the implant site, will be excluded. Additional exclusion criteria include: heavy smoking (more than ten cigarettes per day), presence of active periodontal or peri-implant disease, insulin-dependent diabetes mellitus, history of malignant neoplasia with treatment within the last five years, pregnancy or breastfeeding, lack of effective contraception in women of childbearing age, use of medications that affect soft tissue healing, systemic diseases interfering with connective tissue metabolism (such as autoimmune or arterial diseases), alcohol abuse, collagen allergy, participation in other clinical studies within the previous six months, inadequate oral hygiene (plaque index greater than 25%), or occurrence of any adverse event preventing continuation of treatment.
After inclusion, participants will undergo mucogingival surgery using the VISTA (Vestibular Incision Submucosal Tunnel Access) surgical technique. The Derma OsteoBiol® membrane will be pre-hydrated in sterile saline solution, trimmed, and positioned at the surgical site, and stabilized with monofilament sutures. The incision will be completely closed, avoiding membrane exposure.
Tissue thickness will be assessed through intraoral digital impressions and three-dimensional tissue volume analysis, with measurements performed before surgery and at 1, 3, 6, and 12 months after the intervention. These images will be superimposed using stable anatomical reference points to ensure accuracy and will be analyzed by a calibrated and independent examiner. Clinical data will also be collected throughout the study, including measurements of keratinized mucosa width, probing depth, clinical attachment level, presence of bleeding on probing, plaque index, and gingival recession. Standardized clinical photographs will be obtained at each visit for documentation of soft tissue status and aesthetic evaluation.
Patient perspective will be assessed using the Oral Health Impact Profile questionnaire (OHIP-14) and a numerical pain rating scale, applied at specific follow-up time points. The occurrence of adverse events will be continuously monitored and recorded in accordance with applicable legal and regulatory standards.
This study will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Derma OsteoBiol® | Experimental | Procedure: Soft tissue augmentation with Derma OsteoBiol® around dental implants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • Patients must have the ability to fully understand the nature of the proposed surgery, voluntarily consent to participate and signed the Informed Consent Form before any study related procedures are performed.
Key exclusion criteria (16 listed)
- • Patients who meet any of the following exclusion criteria are not eligible for inclusion in the study.
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 |
|---|---|---|
| Soft tissue augmentation with Derma OsteoBiol® around dental implants.OsteoBiol® Derma collagen membranes will be hydrated in saline before surgery. Using the VISTA technique, a vertical incision apical to the site will be made under local anesthesia, avoiding papillae. A full-thickness flap will be elevated with tunneling instruments. The membrane will be trimmed to fit, placed laterally, and secured with 6/0 monofilament vertical mattress sutures. The incision will be closed with the same suture. | Procedure or surgery | Derma OsteoBiol® |
Primary outcome
Change in 3D Soft Tissue Thickness (mm)
Time frame: 1, 3, 6, and 12 months post-surgery
Digital impressions will be superimposed to assess changes in 3D soft tissue thickness at the buccal aspect of treated implant sites. Measurements will be performed by an independent, calibrated examiner at baseline and at 1, 3, 6, and 12 months post-surgery, following standardized 3D model analysis protocols.
6 secondary outcomes
Patient-Reported Outcomes (PROs)
Time frame: 10 days, 1, 3, 6, and 12 months
General Clinical Measurements
Time frame: screening (-30 to -1), baseline (day 0), Visit 3 - 10 days, Visit 4 - 1 month, Visit 5 - 3 months, Visit 6 - 6 months, Visit 7 - 12 months
Safety Monitoring
Time frame: baseline (day 0), Visit 3 - 10 days, Visit 4 - 1 month, Visit 5 - 3 months, Visit 6 - 6 months, Visit 7 - 12 months
Aesthetic Outcomes
Time frame: screening (-30 to -1), baseline (day 0), Visit 3 - 10 days, Visit 4 - 1 month, Visit 5 - 3 months, Visit 6 - 6 months, Visit 7 - 12 months
Clinical Photographs
Time frame: screening (-30 to -1), baseline (day 0), Visit 3 - 10 days, Visit 4 - 1 month, Visit 5 - 3 months, Visit 6 - 6 months, Visit 7 - 12 months
Pain Assessment (NRS)
Time frame: 10 days, 1 month, and any time the patient reports increased discomfort (through study completion, an average of 1 year).
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 5 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) collected during the study, including demographic characteristics, baseline clinical data, intervention details, primary and secondary outcome measures, and adverse events data. Data dictionaries describing the variables will also be made available.
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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.
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 Soft tissue augmentation with Derma OsteoBiol® around dental implants. in people with Soft Tissue Augmentation Around Dental Implants, run by Universidade do Porto at 1 site in Portugal.
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 16 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: enrolling by invitation, as of the sponsor's last update on 5 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 Portugal. 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?
Change in 3D Soft Tissue Thickness (mm) (time frame: 1, 3, 6, and 12 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 5 May 2026.