Connective Tissue GraftNCT06335628
Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix
A study testing Geistlich Fibro-Gide® in people with Connective Tissue Graft and Volume Collagen Matrix Xenograft, run by University of Bern at 1 site in Switzerland.
Trial summary
The aim of this research project is to compare two surgical procedures to improve soft tissue volume. Both procedures have already been validated, but despite their great clinical relevance, little data exists in the literature. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Connective Tissue Graft, Volume Collagen Matrix Xenograft
- What is being tested?
- Geistlich Fibro-Gide®
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Aug 2024to Apr 2030
- 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
- Informed Consent signed by the subject
- Age ≥ 18 years
- Willingness to sign informed consent and to participate in the study
- Single tooth gap or extended edentulous space in the lower or posterior jaw including a pontic site with a soft tissue deficiency.
- Tooth gap of ≥ 8 mm.
- Presence of natural or artificial opposing dentition
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- Sufficient vertical interocclusal space of an implant restoration (7mm)
- Bounded by natural and periodontally stable teeth
- Treatment plan must include tooth replacement with an implant or tooth-supported fixed dental prosthesis.
Who cannot join
- Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance with the protocol
- Severe bruxism, clenching habits, or presence of oro-facial pain
- Uncontrolled diabetes mellitus (HbA1c >7.0)
- Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- Any active oral or systemic acute infections
- Currently receiving chemo- or radiotherapy or a history of radiotherapy in the head and neck area
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- Severe hematologic disorders
- Any other diseases or medications that may compromise normal wound healing
- Pregnancy or nursing mother
- Contraindications and limitations of the MD as described in the instructions for use: during pregnancy or lactation, children, presence of acute infection in the surgical area, patients with known sensitivity to porcine material or collagen allergies.
- Vulnerable subjects
- Known or suspected non-compliance
- Drug or alcohol abuse
- Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc.
- Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
- Enrolment of the PI, his/her family members, employees and other dependent persons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Bern
Bern, 3010
Martin Schimmel, Prof., +41316840630, martin.schimmel@unibe.ch
Manrique Fonseca, Dr. med. dent.
About this study
The aim of this research project is to compare two surgical procedures to improve soft tissue volume. Both procedures have already been validated, but despite their great clinical relevance, little data exists in the literature. With this study, the investigators aim to evaluate volumetric changes of connective tissue graft versus biomaterial (membrane). In addition, further clinical measurements will be taken and patient satisfaction will be assessed.
- Being tested
- Geistlich Fibro-Gide®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geistlich Fibro-Gide®Device
Geistlich Fibro-Gide® is intended to be used as an implantable device for regeneration and augmentation of soft tissue in oral and maxillofacial surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Connective Tissue Graft (CTG) | No intervention | Volumetric changes between groups will be compared by matching intraoral scans before and after surgery (including follow-ups after 5 years) using the engineering software Geo-Magic®. |
| Group B: Volume Collagen Matrix Xenograft (VCMX) Geistlich Fibro-Gide® | Experimental | The CTG (Group A) is the gold-standard for soft tissue augmentation, therefore it is considered the control group in this investigation. Receives: Device: Geistlich Fibro-Gide® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric dimensional changes
To assess the volumetric dimensional changes in pontic sites after site development using CTG compared to VCMX
Measured: 0-5 years
Secondary outcomes (22)
Clinical: PPD
Clinical: Probing depth in neighboring teeth
Measured: 0-5 years
Clinical BoP
Clinical: Bleeding on probing
Measured: 0-5 years
Clinical: Suppuration
Clinical: Suppuration on probing
Measured: 0-5 years
Clinical: Mucosa
Clinical: Apical migration of the marginal mucosa
Measured: 0-5 years
Clinical: ktw
Clinical: Keratinized tissue width
Measured: 0-5 years
Clinical: Mobility
Clinical: Mobility
Measured: 0-5 years
Clinical: Thickness
Clinical: Mucosal thickness
Measured: 0-5 years
Clinical: Contributing factors
Clinical: Presence of local contributing factors
Measured: 0-5 years
Patient-reported satisfaction
Questionnaire: Overall patient satisfaction with the treatment provided
Measured: 0-5 years
Patient-reported esthetics
Questionnaire: Esthetics
Measured: 0-5 years
Patient-reported discomfort
Questionnaire: Discomfort
Measured: 0-5 years
Patient-reported pain
Questionnaire: Pain
Measured: 0-5 years
Prosthetics Survival
Prosthetic-related: Fixed dental prostheses survival rates
Measured: 0-5 years
Prosthetics Success
Prosthetic-related: Fixed dental prostheses success rates
Measured: 0-5 years
Prosthetics Complications
Prosthetic-related: Technical complications
Measured: 0-5 years
Prosthetics PES-WES
Prosthetic-related: Esthetic score (PES-WES)
Measured: 0-5 years
Prosthetics: Occlusal
Prosthetic-related: Occlusal contacts (static and dynamic)
Measured: 0-5 years
Prosthetics: Interproximal
Prosthetic-related: Presence of interproximal contacts.
Measured: 0-5 years
Radiographics BL
Marginal bone levels
Measured: 0-5 years
Radiographics PP
Periapical pathosis
Measured: 0-5 years
Radiographics distance
Distance from the adjacent teeth/implants
Measured: 0-5 years
Radiographics Contacts
Presence of open contacts
Measured: 0-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start28 Aug 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Connective Tissue GraftStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manrique Fonseca, DDS, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335628
- Sponsor's protocol ID
- RCT: CTG-VCMX
- Status last verified
- May 2026
- First submitted
- 21 Mar 2024
- Last updated
- 27 May 2026
- 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix
- ClinicalTrials.gov ID
- NCT06335628
- Acronym / sponsor ID
- RCT: CTG-VCMX
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 28 Mar 2024 (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 aim of this research project is to compare two surgical procedures to improve soft tissue volume. Both procedures have already been validated, but despite their great clinical relevance, little data exists in the literature. With this study, the investigators aim to evaluate volumetric changes of connective tissue graft versus biomaterial (membrane). In addition, further clinical measurements will be taken and patient satisfaction will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Connective Tissue Graft (CTG) | No intervention | –Volumetric changes between groups will be compared by matching intraoral scans before and after surgery (including follow-ups after 5 years) using the engineering software Geo-Magic®. |
| Group B: Volume Collagen Matrix Xenograft (VCMX) Geistlich Fibro-Gide® | Experimental | Device: Geistlich Fibro-Gide®The CTG (Group A) is the gold-standard for soft tissue augmentation, therefore it is considered the control group in this investigation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed Consent signed by the subject
- Age ≥ 18 years
- Willingness to sign informed consent and to participate in the study
- Single tooth gap or extended edentulous space in the lower or posterior jaw including a pontic site with a soft tissue deficiency.
- Tooth gap of ≥ 8 mm.
Key exclusion criteria (16 listed)
- Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance with the protocol
- Severe bruxism, clenching habits, or presence of oro-facial pain
- Uncontrolled diabetes mellitus (HbA1c >7.0)
- Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- Any active oral or systemic acute infections
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 |
|---|---|---|
| Geistlich Fibro-Gide®Geistlich Fibro-Gide® is intended to be used as an implantable device for regeneration and augmentation of soft tissue in oral and maxillofacial surgery. | Device | Group B: Volume Collagen Matrix Xenograft (VCMX) Geistlich Fibro-Gide® |
Primary outcome
Volumetric dimensional changes
Time frame: 0-5 years
To assess the volumetric dimensional changes in pontic sites after site development using CTG compared to VCMX
22 secondary outcomes
Clinical: PPD
Time frame: 0-5 years
Clinical BoP
Time frame: 0-5 years
Clinical: Suppuration
Time frame: 0-5 years
Clinical: Mucosa
Time frame: 0-5 years
Clinical: ktw
Time frame: 0-5 years
Clinical: Mobility
Time frame: 0-5 years
Clinical: Thickness
Time frame: 0-5 years
Clinical: Contributing factors
Time frame: 0-5 years
Patient-reported satisfaction
Time frame: 0-5 years
Patient-reported esthetics
Time frame: 0-5 years
Patient-reported discomfort
Time frame: 0-5 years
Patient-reported pain
Time frame: 0-5 years
Prosthetics Survival
Time frame: 0-5 years
Prosthetics Success
Time frame: 0-5 years
Prosthetics Complications
Time frame: 0-5 years
Prosthetics PES-WES
Time frame: 0-5 years
Prosthetics: Occlusal
Time frame: 0-5 years
Prosthetics: Interproximal
Time frame: 0-5 years
Radiographics BL
Time frame: 0-5 years
Radiographics PP
Time frame: 0-5 years
Radiographics distance
Time frame: 0-5 years
Radiographics Contacts
Time frame: 0-5 years
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 27 May 2026.
- 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.
Manrique Fonseca, DDS principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geistlich Fibro-Gide® in people with Connective Tissue Graft and Volume Collagen Matrix Xenograft, run by University of Bern at 1 site in Switzerland.
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: looking for participants now, as of the sponsor's last update on 27 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 Switzerland. 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?
Contact Manrique Fonseca, DDS (+41316840630, manrique.fonseca@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric dimensional changes (time frame: 0-5 years). 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 27 May 2026.