Dental ImplantationNCT07782125
Volume-Stable Collagen Matrix vs. Connective Tissue Graft for Peri-Implant Soft Tissue Defects
A study testing Connective tissue graft and Volume-stable collagen matrix in people with Dental Implantation and Peri-Implant Soft Tissue Deficiency, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Peri-implant soft-tissue defects will be treated with either a volume-stable collagen matrix (VCMX; test group) or an autogenous connective tissue graft (CTG; control group) following implant placement in patients with a single missing tooth. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implantation, Peri-Implant Soft Tissue Deficiency, Soft Tissue Augmentation
- 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
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2025to 1 Sep 2026
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 years
- Periodontal health confirmed according to the 2017 World Workshop criteria (BOP <10%, PD ≤3 mm, absence of gingival inflammation, and good oral hygiene) (Tonetti et al., 2018)
- Requirement of implant placement and soft-tissue augmentation for a single missing tooth in the anterior region
- Bleeding on probing <30% at the adjacent teeth (Thoma et al., 2016)
- Compliance with the study protocol and follow-up visits
Who cannot join
- Siebert Class II or Class III defects
- History of surgery at the treated site
- Untreated periodontitis or peri-implantitis
- Current smoking or smoking within the previous five years
- Systemic conditions (that may impair healing)
- Pregnancy or lactation
Show all 9Show fewer
- Allergy to the materials/drugs used
- Drug use affecting mucosal healing
- History of antibiotic therapy within the previous six months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Ankara University
Ankara, Yeni̇mahalle, 06560
Elif Unsal, PHD, +905337627542, unsal.e@gmail.com
About this study
Official title: Clinical, Histological, Biomolecular, and Ultrasonographic Analysis of the Efficacy of a Volume-Stable Collagen Matrix Versus an Autogenous Connective Tissue Graft in the Treatment of Peri-Implant Soft-Tissue Defects
Peri-implant soft-tissue defects will be treated with either a volume-stable collagen matrix (VCMX; test group) or an autogenous connective tissue graft (CTG; control group) following implant placement in patients with a single missing tooth. After a mid-crestal incision and full-thickness flap elevation, the graft material will be positioned over the crest beneath the buccal flap and stabilized, followed by tension-free primary closure. Peri-implant soft-tissue thickness, echo intensity, and vascularization will be assessed non-invasively using high-resolution intraoral ultrasonography and Power Doppler imaging. Clinical periodontal parameters and patient-reported outcomes, including pain perception (visual analog scale), swelling, fatigue, analgesic consumption, and wound healing, will be recorded. These outcomes will be evaluated at baseline and on the 1st week, 1st, 3rd, and 6th months. At the 6th month, gingival biopsy samples obtained during healing abutment placement will be evaluated histologically and immunohistochemically (CD11c, CD163, COL1, COL3, MMP-1, TIMP-1) to compare the biological integration of the two graft materials.
Read the detailed description
Adequate peri-implant soft-tissue thickness is important for both esthetic outcomes and the long-term maintenance of peri-implant health, as thin mucosa has been associated with increased marginal bone loss. Although the autogenous connective tissue graft is considered the gold standard for soft-tissue augmentation, it entails disadvantages such as the need for a second surgical site and donor-site morbidity. The volume-stable collagen matrix has been proposed as an alternative that eliminates the need for a donor site; however, comparative data based on ultrasonographic, histological, and immunohistochemical evidence remain limited. This study aims to compare VCMX and CTG using a multidimensional approach.
The study is designed as a single-center, randomized, controlled clinical trial to be conducted at the Department of Periodontology, Faculty of Dentistry, Ankara University. Participants meeting the eligibility criteria will be allocated to the test (VCMX) and control (CTG) groups. All surgical and clinical procedures will be performed according to standardized protocols, and all data will be recorded prospectively.
The evaluation will adopt a multidimensional methodological approach: the assessment of quantitative data obtained by high-resolution intraoral ultrasonography (soft-tissue thickness, vascularization, and echo intensity) together with histological and immunohistochemical findings constitutes the novel aspect of this study. The primary outcome will be the change in ultrasonographic soft-tissue thickness, whereas the secondary outcomes will comprise vascularization, echo intensity, clinical periodontal parameters, patient-reported outcomes, and the histological/immunohistochemical evaluation of graft integration. In this way, the two graft materials will be compared not only in terms of dimensional gain but also with respect to biological integration and tissue quality.
- Being tested
- Connective tissue graft, Volume-stable collagen matrix
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 connective tissue graft harvested from the palate using the extraoral de-epithelialization technique will be placed over the crest beneath the buccal flap and stabilized with simple interrupted sutures (6-0 polypropylene) to augment peri-implant soft-tissue thickness. (control group)
Volume-stable collagen matrixDevice
A volume-stable porcine-derived collagen matrix (15×20×3 mm) will be trimmed to the defect size, placed over the crest beneath the buccal flap, and stabilized with simple interrupted sutures (6-0 polypropylene) to augment peri-implant soft-tissue thickness. (test group)
| Study group | Role | What they receive |
|---|---|---|
| VCMX Group | Experimental | Soft-tissue augmentation will be performed using a volume-stable collagen matrix (VCMX). Under local anesthesia, a mid-crestal incision combined with sulcular incisions will be made, and a full-thickness flap will be elevated with periosteal releasing incisions to eliminate tension. Implants will be placed according to prosthetic and surgical principles and covered with a cover screw. The VCMX (15×20×3 mm) will be trimmed to the defect size, positioned over the crest beneath the buccal flap, and stabilized with simple interrupted sutures (6-0 polypropylene). Tension-free primary flap closure will be achieved with simple interrupted sutures (5-0 polypropylene). Receives: Device: Volume-stable collagen matrix |
| CTG Group | Active comparator | Soft-tissue augmentation will be performed using an autogenous connective tissue graft (CTG). Under local anesthesia, a mid-crestal incision combined with sulcular incisions will be made, and a full-thickness flap will be elevated with periosteal releasing incisions to eliminate tension. Implants will be placed according to prosthetic and surgical principles and covered with a cover screw. A CTG harvested using the extraoral de-epithelialization technique will be positioned over the crest beneath the buccal flap and stabilized with simple interrupted sutures (6-0 polypropylene). Tension-free primary flap closure will be achieved with simple interrupted sutures (5-0 polypropylene). Receives: Procedure: Connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri-implant soft-tissue thickness
Peri-implant buccal soft-tissue thickness will be measured non-invasively using high-resolution intraoral ultrasonography (LOGIQ P10 XDClear R4.5, GE Healthcare) with an L8-18i-RS high-frequency linear "hockey-stick" probe (8 MHz). Measurements will be repeated preoperatively (baseline) and postoperatively at 1 week, 1 month, 3 months, and 6 months. On static B-mode images, linear soft-tissue thickness will be assessed at three levels 1.5, 3, and 5 mm apical to the alveolar crest margin and recorded in millimeters by a single calibrated examiner blinded to group allocation. The primary outcome is the change in linear soft-tissue thickness from baseline to 6 months, compared between the VCMX and CTG groups.
Measured: Baseline, 1 week, 1 month, 3 months, and 6 months
Secondary outcomes (18)
Peri-implant soft-tissue vascularization
Peri-implant soft-tissue perfusion will be evaluated using Power Doppler ultrasonography (PDUS) with the same unit and probe, preoperatively (baseline) and postoperatively at 1 week, 1 month, 3 months, and 6 months. Quantitative analysis will use the device's integrated Color Quantification (CQ) module: a circular region of interest (ROI) 6 mm in diameter (area 28.274 mm²), originating from the alveolar crest margin, will be defined. Within this ROI, the proportion of colored (Power Doppler) pixels representing blood flow relative to the total number of pixels will be calculated to obtain a semi-quantitative Power Doppler pixel density . The outcome is the change in pixel density from baseline to 6 months, compared between the VCMX and CTG groups.
Measured: Baseline, 1 week, 1 month, 3 months, and 6 months
Ultrasonographic echo intensity of peri-implant soft tissue
Tissue echogenicity will be evaluated preoperatively (baseline) and postoperatively at 1 week, 1 month, 3 months, and 6 months from static B-mode images obtained with the probe positioned longitudinally over the mid-buccal region of the edentulous site. Echo intensity will be measured in decibels (dB) using the unit's grayscale (echo-intensity) function. The ROI will extend 7 mm apically from the soft-tissue margin. As the device references echo intensity to the system's saturation level, soft-tissue reflections yield negative dB values; less negative values indicate higher echogenicity (denser, more organized tissue), and more negative values indicate hypoechoic/less dense tissue. Measurements will be performed by a single calibrated, blinded examiner, with intra-examiner reliability assessed beforehand. The outcome is the change in echo intensity from baseline to 6 months, compared between the VCMX and CTG groups.
Measured: Baseline, 1 week, 1 month, 3 months, and 6 months
Postoperative pain
Patient-rated pain intensity at 1 week, recorded on a Visual Analog Scale (VAS) anchored at 0 (no pain) and 10 (most severe pain). Compared between the VCMX and CTG groups.
Measured: 1 week
Postoperative swelling
Patient-rated swelling at 1 week on a Visual Analog Scale (VAS) from 0 (no swelling) to 10 (most severe). Compared between the VCMX and CTG groups.
Measured: 1 week
Postoperative fatigue
Patient-rated fatigue at 1 week on a Visual Analog Scale (VAS) from 0 (no fatigue) to 10 (most severe). Compared between the VCMX and CTG groups
Measured: 1 week
Number of analgesic tablets consumed
Total number of analgesic tablets taken during the first postoperative week, recorded by patient self-report. Compared between the VCMX and CTG groups.
Measured: 1 week
Early wound healing (Wound Healing Index, WHI)
Early wound healing at 1 week scored with the Wound Healing Index (Huang et al., 2005) based on edema, erythema, discomfort, flap dehiscence, and suppuration, from 1 (uneventful healing) to 3 (poor healing). Compared between the VCMX and CTG groups.
Measured: 1 week
Soft-tissue appearance
Soft-tissue appearance at 6 months graded with the Aichelmann-Reidy et al. (2001) tissue-appearance system across five parameters (tissue consistency, contour, color match, scar formation, and integration with adjacent tissue), each scored against predefined criteria and summed into a total appearance score. Compared between the VCMX and CTG groups.
Measured: 6 months
Patient satisfaction with appearance
Number of participants rating the appearance of the treated site as "satisfactory" versus "not satisfactory" at 6 months. Compared between the VCMX and CTG groups.
Measured: 6 months
Patient satisfaction with experience
Number of participants rating their treatment experience as "satisfactory" versus "not satisfactory" at 6 months. Compared between the VCMX and CTG groups.
Measured: 6 months
Histomorphological evaluation
Descriptive light-microscopic evaluation (hematoxylin-eosin and Masson's trichrome) of tissue architecture, integrity and cellular organization, extracellular matrix organization, and the presence of necrosis, edema, hemorrhage, inflammation, foreign-body reaction, and fibrosis.
Measured: 6 months
Microvascular density
Number of vessels counted in the superficial connective tissue at x400 magnification (single field = 0.237 mm²) across three consecutive fields, averaged per specimen. Compared between the VCMX and CTG groups.
Measured: 6 months
CD163
Number of CD163-positive cells counted at x400 magnification (single field = 0.237 mm²) across three hot-spot fields, averaged per specimen. Compared between the VCMX and CTG groups.
Measured: 6 months
CD11c
Number of CD11c-positive cells counted at x400 magnification (single field = 0.237 mm²) across three hot-spot fields, averaged per specimen. Compared between the VCMX and CTG groups.
Measured: 6 months
TIMP-1
Number of TIMP-1 positive cells counted at x400 magnification (single field = 0.237 mm²) across three hot-spot fields, averaged per specimen. Compared between the VCMX and CTG groups.
Measured: 6 months
MMP-1
Number of MMP-1 positive cells counted at x400 magnification (single field = 0.237 mm²) across three hot-spot fields, averaged per specimen. Compared between the VCMX and CTG groups.
Measured: 6 months
Collagen I
Immunohistochemical Collagen I staining, quantified as the percentage of positively stained area relative to the total microscopic field area. Compared between the VCMX and CTG groups.
Measured: 6 months
Collagen III
Immunohistochemical Collagen III staining, quantified as the percentage of positively stained area relative to the total microscopic field area. Compared between the VCMX and CTG groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start18 Dec 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantationStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Atak, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782125
- Sponsor's protocol ID
- İ03-222-25
- Other IDs
- TSA-2025-4380
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 24 Aug 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Histological, Biomolecular, and Ultrasonographic Analysis of the Efficacy of a Volume-Stable Collagen Matrix Versus an Autogenous Connective Tissue Graft in the Treatment of Peri-Implant Soft-Tissue Defects
- ClinicalTrials.gov ID
- NCT07782125
- Acronym / sponsor ID
- İ03-222-25
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 24 Aug 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.
Peri-implant soft-tissue defects will be treated with either a volume-stable collagen matrix (VCMX; test group) or an autogenous connective tissue graft (CTG; control group) following implant placement in patients with a single missing tooth. After a mid-crestal incision and full-thickness flap elevation, the graft material will be positioned over the crest beneath the buccal flap and stabilized, followed by tension-free primary closure. Peri-implant soft-tissue thickness, echo intensity, and vascularization will be assessed non-invasively using high-resolution intraoral ultrasonography and Power Doppler imaging. Clinical periodontal parameters and patient-reported outcomes, including pain perception (visual analog scale), swelling, fatigue, analgesic consumption, and wound healing, will be recorded. These outcomes will be evaluated at baseline and on the 1st week, 1st, 3rd, and 6th months. At the 6th month, gingival biopsy samples obtained during healing abutment placement will be evaluated histologically and immunohistochemically (CD11c, CD163, COL1, COL3, MMP-1, TIMP-1) to compare the biological integration of the two graft materials.
Detailed description
Adequate peri-implant soft-tissue thickness is important for both esthetic outcomes and the long-term maintenance of peri-implant health, as thin mucosa has been associated with increased marginal bone loss. Although the autogenous connective tissue graft is considered the gold standard for soft-tissue augmentation, it entails disadvantages such as the need for a second surgical site and donor-site morbidity. The volume-stable collagen matrix has been proposed as an alternative that eliminates the need for a donor site; however, comparative data based on ultrasonographic, histological, and immunohistochemical evidence remain limited. This study aims to compare VCMX and CTG using a multidimensional approach.
The study is designed as a single-center, randomized, controlled clinical trial to be conducted at the Department of Periodontology, Faculty of Dentistry, Ankara University. Participants meeting the eligibility criteria will be allocated to the test (VCMX) and control (CTG) groups. All surgical and clinical procedures will be performed according to standardized protocols, and all data will be recorded prospectively.
The evaluation will adopt a multidimensional methodological approach: the assessment of quantitative data obtained by high-resolution intraoral ultrasonography (soft-tissue thickness, vascularization, and echo intensity) together with histological and immunohistochemical findings constitutes the novel aspect of this study. The primary outcome will be the change in ultrasonographic soft-tissue thickness, whereas the secondary outcomes will comprise vascularization, echo intensity, clinical periodontal parameters, patient-reported outcomes, and the histological/immunohistochemical evaluation of graft integration. In this way, the two graft materials will be compared not only in terms of dimensional gain but also with respect to biological integration and tissue quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VCMX Group | Experimental | Device: Volume-stable collagen matrixSoft-tissue augmentation will be performed using a volume-stable collagen matrix (VCMX). Under local anesthesia, a mid-crestal incision combined with sulcular incisions will be made, and a full-thickness flap will be elevated with periosteal releasing incisions to eliminate tension. Implants will be placed according to prosthetic and surgical principles and covered with a cover screw. The VCMX (15×20×3 mm) will be trimmed to the defect size, positioned over the crest beneath the buccal flap, and stabilized with simple interrupted sutures (6-0 polypropylene). Tension-free primary flap closure will be achieved with simple interrupted sutures (5-0 polypropylene). |
| CTG Group | Active comparator | Procedure: Connective tissue graftSoft-tissue augmentation will be performed using an autogenous connective tissue graft (CTG). Under local anesthesia, a mid-crestal incision combined with sulcular incisions will be made, and a full-thickness flap will be elevated with periosteal releasing incisions to eliminate tension. Implants will be placed according to prosthetic and surgical principles and covered with a cover screw. A CTG harvested using the extraoral de-epithelialization technique will be positioned over the crest beneath the buccal flap and stabilized with simple interrupted sutures (6-0 polypropylene). Tension-free primary flap closure will be achieved with simple interrupted sutures (5-0 polypropylene). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years
- Periodontal health confirmed according to the 2017 World Workshop criteria (BOP <10%, PD ≤3 mm, absence of gingival inflammation, and good oral hygiene) (Tonetti et al., 2018)
- Requirement of implant placement and soft-tissue augmentation for a single missing tooth in the anterior region
- Bleeding on probing <30% at the adjacent teeth (Thoma et al., 2016)
- Compliance with the study protocol and follow-up visits
Key exclusion criteria (9 listed)
- Siebert Class II or Class III defects
- History of surgery at the treated site
- Untreated periodontitis or peri-implantitis
- Current smoking or smoking within the previous five years
- Systemic conditions (that may impair healing)
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 connective tissue graft harvested from the palate using the extraoral de-epithelialization technique will be placed over the crest beneath the buccal flap and stabilized with simple interrupted sutures (6-0 polypropylene) to augment peri-implant soft-tissue thickness. (control group) | Procedure or surgery | CTG Group |
| Volume-stable collagen matrixA volume-stable porcine-derived collagen matrix (15×20×3 mm) will be trimmed to the defect size, placed over the crest beneath the buccal flap, and stabilized with simple interrupted sutures (6-0 polypropylene) to augment peri-implant soft-tissue thickness. (test group) | Device | VCMX Group |
Primary outcome
peri-implant soft-tissue thickness
Time frame: Baseline, 1 week, 1 month, 3 months, and 6 months
Peri-implant buccal soft-tissue thickness will be measured non-invasively using high-resolution intraoral ultrasonography (LOGIQ P10 XDClear R4.5, GE Healthcare) with an L8-18i-RS high-frequency linear "hockey-stick" probe (8 MHz). Measurements will be repeated preoperatively (baseline) and postoperatively at 1 week, 1 month, 3 months, and 6 months. On static B-mode images, linear soft-tissue thickness will be assessed at three levels 1.5, 3, and 5 mm apical to the alveolar crest margin and recorded in millimeters by a single calibrated examiner blinded to group allocation. The primary outcome is the change in linear soft-tissue thickness from baseline to 6 months, compared between the VCMX and CTG groups.
18 secondary outcomes
Peri-implant soft-tissue vascularization
Time frame: Baseline, 1 week, 1 month, 3 months, and 6 months
Ultrasonographic echo intensity of peri-implant soft tissue
Time frame: Baseline, 1 week, 1 month, 3 months, and 6 months
Postoperative pain
Time frame: 1 week
Postoperative swelling
Time frame: 1 week
Postoperative fatigue
Time frame: 1 week
Number of analgesic tablets consumed
Time frame: 1 week
Early wound healing (Wound Healing Index, WHI)
Time frame: 1 week
Soft-tissue appearance
Time frame: 6 months
Patient satisfaction with appearance
Time frame: 6 months
Patient satisfaction with experience
Time frame: 6 months
Histomorphological evaluation
Time frame: 6 months
Microvascular density
Time frame: 6 months
CD163
Time frame: 6 months
CD11c
Time frame: 6 months
TIMP-1
Time frame: 6 months
MMP-1
Time frame: 6 months
Collagen I
Time frame: 6 months
Collagen III
Time frame: 6 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 24 Aug 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.
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 Implantation and Peri-Implant Soft Tissue Deficiency, run by Ankara University at 1 site in Turkey (Türkiye).
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 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: looking for participants now, as of the sponsor's last update on 24 Aug 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 Turkey (Türkiye). 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 Sivge Kurgan, PHD (+905325495235, sivgeakgun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peri-implant soft-tissue thickness (time frame: Baseline, 1 week, 1 month, 3 months, and 6 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 24 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.