Keratinized Tissue Augmentation Around Dental ImplantsNCT07863882
Keratinized Tissue Augmentation Using Augmented Gingival Matrix Compared to Free Gingival Graft Around Implants
A study testing Augmented Gingival Matrix graft and Free Gingival Graft in people with Keratinized Tissue Augmentation Around Dental Implants, run by The Forsyth Institute at 1 site in United States.
Trial summary
This is a 12-month, randomized, examiner-blinded, controlled, two-arm, parallel-group, single-site clinical trial comparing a biocompatible tissue graft (Augmented Gingival Matrix barrier) with a free gingival graft (FGG) to increase the keratinized tissue around implants in medically healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratinized Tissue Augmentation Around Dental Implants
- What is being tested?
- Augmented Gingival Matrix graft and Free Gingival Graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Willing and able to abide by the terms of the consent form and sign the Informed Consent form
- Good general health as evidenced by medical history
- Ages 18 and over
- Edentulous or partially edentulous patients who had undergone dental implant surgery
- Patients exhibiting KT/mucosa width of >0.5 but <2 mm at the buccal aspect of the implant, subjected to surgical intervention either at the time of second-stage surgery after placement of healing abutments (i.e., 3 to 5 months following submerged healing) or implants in function
- Presence of peri-implant tissue health determined by the study clinician
- Adequate oral hygiene as evidenced by plaque index (FMPS<20%).
Who cannot join
- • Willing and able to abide by the terms of the consent form and sign the Informed Consent form
- Good general health as evidenced by medical history
- Ages 18 and over
- Edentulous or partially edentulous patients who had undergone dental implant surgery
- Patients exhibiting KT/mucosa width of >0.5 but <2 mm at the buccal aspect of the implant, subjected to surgical intervention either at the time of second-stage surgery after placement of healing abutments (i.e., 3 to 5 months following submerged healing) or implants in function
- Presence of peri-implant tissue health determined by the study clinician
- Adequate oral hygiene as evidenced by plaque index (FMPS<20%).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
ADA Forsyth Institute
Somerville, Massachusetts, 02134
Director, Center for Clinical and Transl Research, hhasturk@forsyth.org
About this study
Official title: A Randomized Controlled Clinical Trial to Assess Soft Tissue Quantity and Quality Following the Use of Augmented Gingival Matrix Compared to Free Gingival Graft Around Implants-A 12-month Follow-up Study
This is a 12-month, randomized, examiner-blinded, controlled, two-arm, parallel-group, single-site clinical trial comparing a biocompatible tissue graft (Augmented Gingival Matrix barrier) with a free gingival graft (FGG) to increase the keratinized tissue around implants in medically healthy subjects. Subjects will be enrolled in a balanced manner (1:1; treatment:control) into one of the 2 following treatment arms for keratinized tissue augmentation:
- Group A: Augmented Gingival Matrix barrier (Test group)
- Group B: Free gingival graft (Control Group)
Read the detailed description
This is a prospective, 12-month, randomized, examiner-blinded, controlled, two-arm, parallel-group, multi-site clinical trial with a 1:1 allocation ratio comparing Augmented Gingival Matrix barrier (AGM, test graft) with a free gingival graft (FGG; standard of care) around implants in medically healthy subjects.
This randomized controlled clinical trial is designed to compare free gingival graft and AGM graft with respect to both effectiveness and safety when used around dental implants. The primary outcome will be the gain in keratinized tissue width after 12 months. Secondary outcomes will include gingival thickness gain, changes in pocket depth, gingival index, and bleeding on probing, graft contraction, patient-reported pain, treatment satisfaction, and adverse events. The inclusion of both clinician- and patient-reported outcomes will provide a comprehensive evaluation of treatment performance.
- Being tested
- Augmented Gingival Matrix graft, Free Gingival Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Gingival Matrix graftDevice
Also called Free Gingival Graft
After administration of local anesthesia (2% lidocaine/articaine, 1:100.000 epinephrine), implant sites undergoing a simultaneous second-stage surgery will be uncovered, and healing abutments will be inserted. The recipient bed will be prepared using a 15-stainless steel blade by performing a horizontal split-thickness incision above the mucogingival junction (MGJ) on the attached gingiva at the buccal aspect of the implants. The AGM graft will be processed according to the manufacturer's instructions. The graft will be trimmed to fit the recipient bed and secured using interrupted sutures (e.g., 5-0 or 6-0 monofilament).
Free Gingival GraftProcedure or surgery
Recipient bed preparation will be similar to the AGM intervention. A free gingival graft will be harvested from the palate, typically 1.5-2.0 mm thick, aiming for dimensions suitable for the recipient site. The graft will be trimmed and secured to the recipient bed using interrupted sutures (e.g., 5-0 or 6-0 monofilament suture. A periodontal dressing will be placed over the donor site.
| Study group | Role | What they receive |
|---|---|---|
| Augmented Gingival Matrix graft | Active comparator | A biomaterial, namely the Augmented Gingival Matrix (AGM) barrier, will be used as the Test product. It is a bovine-derived, three-layered structure with two external gelatin fiber layers and a central polycaprolactone (PCL) layer. This is an FDA-cleared device. Receives: Device: Augmented Gingival Matrix graft |
| Free Gingival Graft | Active comparator | Free Gingival Graft obtained from the palatal area will serve as the gold-standard control group. Receives: Procedure: Free Gingival Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in keratinized tissue width
Measured from the free gingival margin to the mucogingival junction using a periodontal probe at the mid-buccal/lingual aspect of the treated implant. Changes at 6 months from baseline will be used as the primary outcome measure.
Measured: 6 months
Secondary outcomes (11)
Keratinized Tissue Width (KTW)
Changes at 3 and 12 months from baseline
Measured: 3 and 12 months
Gingival (keratized tissue) Thickness
Intraoral digital scans of the treated area will be captured using an intraoral scanner (3Shape TRIOS or iTero) before the procedure and at 6 and 12 months post-healing. To enable accurate superimposition of scans taken at multiple points, care was taken to capture reproducible, fixed reference points (i.e., adjacent teeth/implants). The scanned files will be converted to STL format and exported into a software program for superimposition. The digital models will be aligned by manually selecting reproducible points on fixed anatomical structures.
Measured: 6 and 12 months
% Graft Shrinkage
Graft dimensions in mm will be measured over time at 3, 6, and 12 months, and changes in graft dimensions will be calculated.
Measured: 3, 6 and 12 months
Change in Probing Depth (PD)
Periodontal pocket depth (PD) will be determined with a calibrated UNC-15 periodontal probe at 6 sites per tooth, rounded down to the nearest whole millimeter. Around implants, distance from the free gingival margin to the base of the peri-implant sulcus will be measured. PD will be measured at baseline, 3, 6, and 12 months.
Measured: 3, 6, and 12 months
Change in Modified Gingival Index (MGI)
MGI will be recorded at 6 sites per tooth using the following 5-point ordinal scale: 0 = Absence of inflammation; 1 = Mild inflammation; slight change in color, little change in texture of any portion of, but not the entire, marginal or papillary gingival unit; 2 = Mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit; 3 = Moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit; 4 = Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration.
Measured: 3, 6, and 12 months.
Change in Bleeding on Probing (BOP):
Dichotomous score of 0 or 1 indicating whether the site bleeds within 15 seconds upon probing is performed: 0 = No bleeding; 1 = Bleeding within 15 seconds following probing. Bleeding on probing will be measured at 6 sites on the tooth. Percent bleeding will be calculated based on the total sites measured.
Measured: 3, 6 and 12 months
Change in Plaque Score
The presence of plaque on buccal and lingual surfaces of the teeth will be assessed using a dichotomous score representing the presence or absence of plaque: 0 = No visible plaque present; 1 = Visible plaque present
Measured: 3, 6 and 12 months
Patient-Reported Outcomes (PROs)
Questionnaires: Post-procedure pain, anesthesia-related experiences, hypersensitivity, and bleeding, etc.
Visual Analog Scale (VAS) for pain and discomfort (recipient and donor site for FGG and recipient site for AGM) at 10 days and at 3, 6, and 12 months. A Visual analogue scale (VAS) is used to assess a subjective rating using a horizontal line with words that represent two opposing extremes (e.g., "How painful does your mouth feel") onto which a respondent is asked to make a vertical mark corresponding to their feelings in relation to the two extremes. VAS questionnaire will be used to assess subjective pain ratings, with each translated to a 0 to 100 scale.
- Impact on daily activities (e.g., eating, speaking) on day 10.
- Esthetic satisfaction at 3, 6, and 12 months.
- Overall satisfaction at 3, 6, and 12 months.
Measured: 10 days, 3, 6 and 12 months
Clinician-Reported Outcomes (ClinROs)
A questionnaire will be used to survey clinicians' satisfaction, ease of use, treatment outcomes, etc.
Measured: 3, 6, and 12 months
Adverse Events
Any unanticipated or untoward medical occurrence experienced by a study participant, regardless of causality. Recorded at all follow-up visits.
Measured: baseline, 14 days, 1 month, 3 months, 6 months and 12 months
Duration of Surgery
The surgical time required to complete each procedure will be measured to the closest minute from the start of the incision to the completion of the last suture.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratinized 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 12-month, randomized, examiner-blinded, controlled, two-arm, parallel-group, single-site clinical trial comparing the Augmented Gingival Matrix barrier with a free gingival graft (FGG) to increase the amount of keratinized tissue around implants in medically healthy subjects. Subjects will be enrolled in a balanced manner (1:1; treatment:control)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Forsyth Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Hasturk, The Forsyth Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863882
- Sponsor's protocol ID
- AGM-KT-001
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial to Assess Soft Tissue Quantity and Quality Following the Use of Augmented Gingival Matrix Compared to Free Gingival Graft Around Implants-A 12-month Follow-up Study
- ClinicalTrials.gov ID
- NCT07863882
- Acronym / sponsor ID
- AGM-KT-001
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Forsyth InstituteUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 7 Oct 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 is a 12-month, randomized, examiner-blinded, controlled, two-arm, parallel-group, single-site clinical trial comparing a biocompatible tissue graft (Augmented Gingival Matrix barrier) with a free gingival graft (FGG) to increase the keratinized tissue around implants in medically healthy subjects. Subjects will be enrolled in a balanced manner (1:1; treatment:control) into one of the 2 following treatment arms for keratinized tissue augmentation:
- Group A: Augmented Gingival Matrix barrier (Test group)
- Group B: Free gingival graft (Control Group)
Detailed description
This is a prospective, 12-month, randomized, examiner-blinded, controlled, two-arm, parallel-group, multi-site clinical trial with a 1:1 allocation ratio comparing Augmented Gingival Matrix barrier (AGM, test graft) with a free gingival graft (FGG; standard of care) around implants in medically healthy subjects.
This randomized controlled clinical trial is designed to compare free gingival graft and AGM graft with respect to both effectiveness and safety when used around dental implants. The primary outcome will be the gain in keratinized tissue width after 12 months. Secondary outcomes will include gingival thickness gain, changes in pocket depth, gingival index, and bleeding on probing, graft contraction, patient-reported pain, treatment satisfaction, and adverse events. The inclusion of both clinician- and patient-reported outcomes will provide a comprehensive evaluation of treatment performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a 12-month, randomized, examiner-blinded, controlled, two-arm, parallel-group, single-site clinical trial comparing the Augmented Gingival Matrix barrier with a free gingival graft (FGG) to increase the amount of keratinized tissue around implants in medically healthy subjects. Subjects will be enrolled in a balanced manner (1:1; treatment:control)
| Arm | Type | Receives |
|---|---|---|
| Augmented Gingival Matrix graft | Active comparator | Device: Augmented Gingival Matrix graftA biomaterial, namely the Augmented Gingival Matrix (AGM) barrier, will be used as the Test product. It is a bovine-derived, three-layered structure with two external gelatin fiber layers and a central polycaprolactone (PCL) layer. This is an FDA-cleared device. |
| Free Gingival Graft | Active comparator | Procedure: Free Gingival GraftFree Gingival Graft obtained from the palatal area will serve as the gold-standard control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Willing and able to abide by the terms of the consent form and sign the Informed Consent form
Key exclusion criteria (7 listed)
- • Willing and able to abide by the terms of the consent form and sign the Informed Consent form
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 |
|---|---|---|
| Augmented Gingival Matrix graftAlso: Free Gingival GraftAfter administration of local anesthesia (2% lidocaine/articaine, 1:100.000 epinephrine), implant sites undergoing a simultaneous second-stage surgery will be uncovered, and healing abutments will be inserted. The recipient bed will be prepared using a 15-stainless steel blade by performing a horizontal split-thickness incision above the mucogingival junction (MGJ) on the attached gingiva at the buccal aspect of the implants. The AGM graft will be processed according to the manufacturer's instructions. The graft will be trimmed to fit the recipient bed and secured using interrupted sutures (e.g., 5-0 or 6-0 monofilament). | Device | Augmented Gingival Matrix graft |
| Free Gingival GraftRecipient bed preparation will be similar to the AGM intervention. A free gingival graft will be harvested from the palate, typically 1.5-2.0 mm thick, aiming for dimensions suitable for the recipient site. The graft will be trimmed and secured to the recipient bed using interrupted sutures (e.g., 5-0 or 6-0 monofilament suture. A periodontal dressing will be placed over the donor site. | Procedure or surgery | Free Gingival Graft |
Primary outcome
Change in keratinized tissue width
Time frame: 6 months
Measured from the free gingival margin to the mucogingival junction using a periodontal probe at the mid-buccal/lingual aspect of the treated implant. Changes at 6 months from baseline will be used as the primary outcome measure.
11 secondary outcomes
Keratinized Tissue Width (KTW)
Time frame: 3 and 12 months
Gingival (keratized tissue) Thickness
Time frame: 6 and 12 months
% Graft Shrinkage
Time frame: 3, 6 and 12 months
Change in Probing Depth (PD)
Time frame: 3, 6, and 12 months
Change in Modified Gingival Index (MGI)
Time frame: 3, 6, and 12 months.
Change in Bleeding on Probing (BOP):
Time frame: 3, 6 and 12 months
Change in Plaque Score
Time frame: 3, 6 and 12 months
Patient-Reported Outcomes (PROs)
Time frame: 10 days, 3, 6 and 12 months
Clinician-Reported Outcomes (ClinROs)
Time frame: 3, 6, and 12 months
Adverse Events
Time frame: baseline, 14 days, 1 month, 3 months, 6 months and 12 months
Duration of Surgery
Time frame: Baseline
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 7 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Keratinized Tissue Augmentation Around Dental Implants
Recruiting
CTG Versus Collagen Matrix for Peri-Implant Soft Tissue Augmentation
Peri-implant Soft Tissue Deficiency, Insufficient Peri-implant Keratinized Tissue
Recruiting
Clinical Evaluation of a Modified Technique for Free Gingival Graft Stabilization Using Titanium Fixation Tacs Around Implants Versus Conventional Suturing Technique
Free Gingival Graft, Soft Tissue Augmentation Around Dental Implants
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 Augmented Gingival Matrix graft and Free Gingival Graft in people with Keratinized Tissue Augmentation Around Dental Implants, run by The Forsyth Institute at 1 site in United States.
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 7 Oct 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 United States. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in keratinized tissue width (time frame: 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 7 Oct 2026.