Peri-implant Soft Tissue DeficiencyNCT07371481
CTG Versus Collagen Matrix for Peri-Implant Soft Tissue Augmentation
A study testing Collagen Matrix and Connective Tissue Graft in people with Peri-implant Soft Tissue Deficiency and Insufficient Peri-implant Keratinized Tissue, run by Hanoi Medical University at 1 site in Vietnam.
Trial summary
This randomized controlled trial compares two techniques for peri-implant soft tissue augmentation in the mandibular molar region: an autogenous connective tissue graft (CTG) and a collagen matrix. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peri-implant Soft Tissue Deficiency, Insufficient Peri-implant Keratinized Tissue
- What is being tested?
- Collagen Matrix and Connective Tissue Graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jan 2026to Sep 2028
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years.
- Patients requiring dental implant treatment in the mandibular molar region.
- Presence of insufficient peri-implant soft tissue thickness (< 2 mm).
- Adequate general health to undergo minor oral surgery.
- Ability and willingness to provide written informed consent and comply with study procedures.
Who cannot join
- Systemic conditions or medications that may impair wound healing.
- Heavy smoking (more than 10 cigarettes per day).
- History of allergy or hypersensitivity to collagen-based materials.
- Previous graft failure or complications at the intended implant site.
- Loss of three or more adjacent teeth in the study area (excluding third molars).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
School of Dentistry, Hanoi Medical University
Hanoi, 100000
About this study
Official title: Results of Soft Tissue Grafting Around Implant in the Mandible Molar Area
This randomized controlled trial compares two techniques for peri-implant soft tissue augmentation in the mandibular molar region: an autogenous connective tissue graft (CTG) and a collagen matrix. Adult patients requiring implant treatment with insufficient peri-implant soft tissue thickness will be randomly assigned to receive either CTG or a collagen matrix at the time of implant surgery.
The study aims to evaluate and compare changes in peri-implant soft tissue thickness, width of keratinized tissue, and soft tissue contour over a 9-month follow-up period, as well as the occurrence of postoperative complications. The results of this study will help determine whether a collagen matrix can provide clinical outcomes comparable to those of connective tissue grafting for peri-implant soft tissue augmentation.
Read the detailed description
This randomized controlled trial is designed to compare two approaches for peri-implant soft tissue augmentation in the mandibular molar region: an autogenous connective tissue graft (CTG) and a collagen matrix. Adult patients with insufficient peri-implant soft tissue thickness will be enrolled and randomly allocated in a 1:1 ratio to receive either CTG or a collagen matrix at the time of implant surgery. Randomization will be performed using a block randomization method, and outcome assessment will be conducted by a blinded examiner.
Clinical and digital evaluations will be performed at predefined time points, including baseline and follow-up visits up to 9 months after surgery. Peri-implant soft tissue thickness, width of keratinized tissue, and soft tissue contour changes will be assessed using standardized clinical measurements and digital workflows based on intraoral scanning and cone-beam computed tomography where indicated. Postoperative healing and adverse events will be monitored throughout the follow-up period.
The study is conducted at a single academic center and is intended to provide comparative clinical data on the effectiveness and safety of collagen matrix versus connective tissue grafting for peri-implant soft tissue augmentation.
- Being tested
- Collagen Matrix, Connective Tissue Graft
- Keywords
- Peri-implant soft tissue augmentation, Connective tissue graft, Collagen matrix, Dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen MatrixDevice
A porcine-derived collagen matrix is used for peri-implant soft tissue augmentation at the time of implant surgery, serving as a substitute for autogenous connective tissue grafting.
Connective Tissue GraftProcedure or surgery
An autogenous connective tissue graft harvested from the patient is used for peri-implant soft tissue augmentation at the time of implant surgery.
| Study group | Role | What they receive |
|---|---|---|
| Connective Tissue Graft (CTG) | Active comparator | Peri-implant soft tissue augmentation using autogenous connective tissue graft. Receives: Procedure: Connective Tissue Graft |
| Collagen Matrix | Experimental | Peri-implant soft tissue augmentation using a collagen matrix. Receives: Device: 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 using standardized digital methods.
Measured: Baseline (before surgery) to 9 months after surgery
Secondary outcomes (3)
Change in width of peri-implant keratinized tissue
Change in the width of keratinized tissue around the implant measured clinically using standardized procedures.
Measured: Baseline to 9 months after surgery
Change in peri-implant marginal bone level
Changes in marginal bone level assessed using cone-beam computed tomography where indicated.
Measured: Baseline to 9 months after surgery
Peri-implant clinical indices
Assessment of peri-implant inflammation using standardized clinical indices.
Measured: Up to 9 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Jan 2026
- Primary completionDec 2027 (estimated)
- Study completionSep 2028 (estimated)
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 DeficiencyStudies 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 are randomly assigned in a 1:1 ratio to one of two parallel groups to receive either a connective tissue graft or a collagen matrix for peri-implant soft tissue augmentation, with no crossover between groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DUC NGUYEN MINH, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371481
- Sponsor's protocol ID
- 01250159
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2026
- Last updated
- 16 Sep 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 because the dataset contains sensitive clinical and imaging information, and data sharing was not included in the approved study protocol or informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Soft Tissue Grafting Around Implant in the Mandible Molar Area
- ClinicalTrials.gov ID
- NCT07371481
- Acronym / sponsor ID
- 01250159
- Keywords
- Peri-implant soft tissue augmentation, Connective tissue graft, Collagen matrix, Dental implant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 28 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 randomized controlled trial compares two techniques for peri-implant soft tissue augmentation in the mandibular molar region: an autogenous connective tissue graft (CTG) and a collagen matrix. Adult patients requiring implant treatment with insufficient peri-implant soft tissue thickness will be randomly assigned to receive either CTG or a collagen matrix at the time of implant surgery.
The study aims to evaluate and compare changes in peri-implant soft tissue thickness, width of keratinized tissue, and soft tissue contour over a 9-month follow-up period, as well as the occurrence of postoperative complications. The results of this study will help determine whether a collagen matrix can provide clinical outcomes comparable to those of connective tissue grafting for peri-implant soft tissue augmentation.
Detailed description
This randomized controlled trial is designed to compare two approaches for peri-implant soft tissue augmentation in the mandibular molar region: an autogenous connective tissue graft (CTG) and a collagen matrix. Adult patients with insufficient peri-implant soft tissue thickness will be enrolled and randomly allocated in a 1:1 ratio to receive either CTG or a collagen matrix at the time of implant surgery. Randomization will be performed using a block randomization method, and outcome assessment will be conducted by a blinded examiner.
Clinical and digital evaluations will be performed at predefined time points, including baseline and follow-up visits up to 9 months after surgery. Peri-implant soft tissue thickness, width of keratinized tissue, and soft tissue contour changes will be assessed using standardized clinical measurements and digital workflows based on intraoral scanning and cone-beam computed tomography where indicated. Postoperative healing and adverse events will be monitored throughout the follow-up period.
The study is conducted at a single academic center and is intended to provide comparative clinical data on the effectiveness and safety of collagen matrix versus connective tissue grafting for peri-implant soft tissue augmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to one of two parallel groups to receive either a connective tissue graft or a collagen matrix for peri-implant soft tissue augmentation, with no crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| Connective Tissue Graft (CTG) | Active comparator | Procedure: Connective Tissue GraftPeri-implant soft tissue augmentation using autogenous connective tissue graft. |
| Collagen Matrix | Experimental | Device: Collagen MatrixPeri-implant soft tissue augmentation using a collagen matrix. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 65 years.
- Patients requiring dental implant treatment in the mandibular molar region.
- Presence of insufficient peri-implant soft tissue thickness (< 2 mm).
- Adequate general health to undergo minor oral surgery.
- Ability and willingness to provide written informed consent and comply with study procedures.
Key exclusion criteria (5 listed)
- Systemic conditions or medications that may impair wound healing.
- Heavy smoking (more than 10 cigarettes per day).
- History of allergy or hypersensitivity to collagen-based materials.
- Previous graft failure or complications at the intended implant site.
- Loss of three or more adjacent teeth in the study area (excluding third molars).
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 |
|---|---|---|
| Collagen MatrixA porcine-derived collagen matrix is used for peri-implant soft tissue augmentation at the time of implant surgery, serving as a substitute for autogenous connective tissue grafting. | Device | Collagen Matrix |
| Connective Tissue GraftAn autogenous connective tissue graft harvested from the patient is used for peri-implant soft tissue augmentation at the time of implant surgery. | Procedure or surgery | Connective Tissue Graft (CTG) |
Primary outcome
Change in peri-implant soft tissue thickness
Time frame: Baseline (before surgery) to 9 months after surgery
Change in peri-implant soft tissue thickness measured using standardized digital methods.
3 secondary outcomes
Change in width of peri-implant keratinized tissue
Time frame: Baseline to 9 months after surgery
Change in peri-implant marginal bone level
Time frame: Baseline to 9 months after surgery
Peri-implant clinical indices
Time frame: Up to 9 months after surgery
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 16 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset contains sensitive clinical and imaging information, and data sharing was not included in the approved study protocol or informed consent.
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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 Collagen Matrix and Connective Tissue Graft in people with Peri-implant Soft Tissue Deficiency and Insufficient Peri-implant Keratinized Tissue, run by Hanoi Medical University at 1 site in Vietnam.
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 5 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 16 Sep 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 Vietnam. 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 Phu Manh Nguyen, DDS, MSc ((+84) 2435747005, manhphu@hmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peri-implant soft tissue thickness (time frame: Baseline (before surgery) to 9 months after 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 16 Sep 2026.