Dental ImplantsNCT07346391
Augmentation of Peri-implant Keratinized Mucosa Using a Combination of Free Gingival Graft Strip With Platelet-Rich Fibrin
A study testing Combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa around dental implants and Conventional Free Gingival Graft (FGG) to increase keratinized mucosa around dental implants in people with Dental Implants, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
This clinical trial aims to evaluate the clinical effectiveness of combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) for increasing keratinized mucosa around dental implants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dental Implants
- What is being tested?
- Combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa around dental implants and Conventional Free Gingival Graft (FGG) to increase keratinized mucosa around dental implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteVietnam
- Study dates
- 24 Dec 2025to 16 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients meeting the following criteria are eligible for the study:
- Prosthetic Phase: Patients scheduled for the prosthetic phase of dental implant treatment.
- Keratinized Mucosa: Keratinized mucosa height (buccal or lingual) of less than 2 mm around the implant.
- Systemic Health: Systemic health status classified as ASA I or II according to the American Society of Anesthesiologists classification.
- Oral Hygiene: Good oral hygiene, defined by a mean full-mouth plaque index (PlI) of ≤ 1.
Who cannot join
- Patients meeting any of the following criteria will be excluded from the study:
- Systemic Conditions: Presence of systemic diseases or use of medications known to affect the oral mucosa or gingival health.
- Periodontal Health: Untreated periodontal disease and/or peri-implant diseases.
- Surgical History: History of mucogingival surgery at the intended surgical site.
- Pregnancy/Lactation: Pregnant or breastfeeding women.
- Oral Hygiene: Poor oral hygiene, defined by a mean full-mouth plaque index (PlI) > 1.
- Smoking: Current smokers.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Phòng Khám Chuyên Khoa Răng Hàm Mặt Đại Học Y Dược Thành Phố Hồ Chí Minh
HỒ CHÍ MINH, VIỆT NAM, 123456789
About this study
Official title: Clinical Effectiveness of Combining Free Gingival Strip Graft With Platelet-Rich Fibrin for Peri-Implant Keratinized Mucosa Augmentation
This clinical trial aims to evaluate the clinical effectiveness of combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) for increasing keratinized mucosa around dental implants. The study compares this combined technique with the conventional free gingival graft (FGG) method through three primary objectives:
- comparing the increase in keratinized mucosal height at immediate post-op, 1, 3, and 6 months;
- assessing post-operative pain levels at 1, 3, 7, and 14 days;
- evaluating soft tissue aesthetic outcomes at 6 months post-surgery.
Read the detailed description
Pre-operative phase:
Eligible patients undergo clinical examination and medical record documentation. Written informed consent is obtained prior to enrollment. Participants are randomly assigned by drawing one of 22 sealed envelopes: odd numbers are allocated to Group A (strip free gingival graft with PRF) and even numbers to Group B (conventional free gingival graft). Baseline intraoral and extraoral photographs and intraoral scans (PLY format) are obtained.
Intra-operative phase:
- Group A (Experimental): PRF is prepared from venous blood. A strip free gingival graft is harvested from the palate and placed at the recipient site in combination with PRF.
- Group B (Control): A conventional free gingival graft is harvested from the palate and placed at the recipient site.
Post-operative phase:
Follow-up visits are conducted at days 1, 3, 7, and 14, and at 1, 3, and 6 months post-surgery. At 1 month, healing abutments are placed and prosthetic treatment begins and impressions were taken 2 weeks later. In another 2 weeks, the final restorations were delivered. Keratinized mucosa changes are assessed using pre- and post-operative intraoral scans. Post-operative pain is evaluated using the Visual Analog Scale (VAS), and soft tissue aesthetic outcomes are assessed at 6 months using a standardized aesthetic score.
- Conditions
- Dental Implants
- Being tested
- Combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa around dental implants, Conventional Free Gingival Graft (FGG) to increase keratinized mucosa around dental implants
- Keywords
- Combination technique of strip free gingival grafts and PRF in augmenting keratinized mucosa around dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa around dental implantsProcedure or surgery
Venous blood is collected using a butterfly needle and 10ml tubes to prepare the PRF membrane. A keratinized mucosa strip of appropriate dimensions is harvested from the patient's palate. The strip free gingival graft and PRF membrane are then sutured and stabilized at the recipient site.
Conventional Free Gingival Graft (FGG) to increase keratinized mucosa around dental implantsProcedure or surgery
A surgical procedure where a graft consisting of epithelium and connective tissue is harvested from the palate and transplanted to the peri-implant area to increase the width and height of keratinized
| Study group | Role | What they receive |
|---|---|---|
| Conventional Free Gingival Graft (FGG) | Experimental | A surgical procedure where a graft consisting of epithelium and connective tissue is harvested from the palate and transplanted to the peri-implant area to increase the width and height of keratinized mucosa Receives: Procedure: Conventional Free Gingival Graft (FGG) to increase keratinized mucosa around dental implants |
| Combining a strip free gingival graft with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa | Experimental | Venous blood is collected using a butterfly needle and 10ml tubes to prepare the PRF membrane. A keratinized mucosa strip of appropriate dimensions is harvested from the patient's palate. The strip free gingival graft and PRF membrane are then sutured and stabilized at the recipient site. Receives: Procedure: Combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa around dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the increase in peri-implant keratinized mucosa width and mucosa thickness
KMW and MT were assessed using STL surface data at 1, 3, and 6 months
Measured: 1, 3, 6 months
Soft tissue esthetics assessed by the modified Pink Esthetic Score (PES)
"The esthetic outcome of the peri-implant soft tissue is evaluated using the modified Pink Esthetic Score (PES) as described by Fürhauser et al. (2005). The assessment compares the grafted area to the adjacent natural tooth based on parameters: Soft tissue color difference, soft tissue texture difference, soft tissue contour difference.
Each parameter is assigned a score of 0, 1, or 2 (0 being the lowest, 2 being the highest/most esthetic). The total PES score ranges from 0 to 6, where a higher score indicates a superior esthetic result
Measured: 6 months post-operatively
Post-operative pain intensity measured by Visual Analog Scale (VAS)
Pain intensity is measured on a Visual Analog Scale from 0 (no pain) to 10 (unbearable pain). Participants will be asked to mark their level of discomfort at each time point.
Measured: 1, 3, 7 and 14 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start24 Dec 2025
- Primary completion16 Jul 2026
- Study completion16 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Van Khuong, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346391
- Sponsor's protocol ID
- 25309-DHYD
- Status last verified
- Jul 2026
- First submitted
- 23 Dec 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Combining Free Gingival Strip Graft With Platelet-Rich Fibrin for Peri-Implant Keratinized Mucosa Augmentation
- ClinicalTrials.gov ID
- NCT07346391
- Acronym / sponsor ID
- 25309-DHYD
- Conditions
- Dental Implants
- Keywords
- Combination technique of strip free gingival grafts and PRF in augmenting keratinized mucosa around dental implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 24 Dec 2025 (actual)
- Primary completion
- 16 Jul 2026 (actual)
- Study completion
- 16 Jul 2026 (actual)
- First posted
- 16 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 clinical trial aims to evaluate the clinical effectiveness of combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) for increasing keratinized mucosa around dental implants. The study compares this combined technique with the conventional free gingival graft (FGG) method through three primary objectives:
- comparing the increase in keratinized mucosal height at immediate post-op, 1, 3, and 6 months;
- assessing post-operative pain levels at 1, 3, 7, and 14 days;
- evaluating soft tissue aesthetic outcomes at 6 months post-surgery.
Detailed description
Pre-operative phase:
Eligible patients undergo clinical examination and medical record documentation. Written informed consent is obtained prior to enrollment. Participants are randomly assigned by drawing one of 22 sealed envelopes: odd numbers are allocated to Group A (strip free gingival graft with PRF) and even numbers to Group B (conventional free gingival graft). Baseline intraoral and extraoral photographs and intraoral scans (PLY format) are obtained.
Intra-operative phase:
- Group A (Experimental): PRF is prepared from venous blood. A strip free gingival graft is harvested from the palate and placed at the recipient site in combination with PRF.
- Group B (Control): A conventional free gingival graft is harvested from the palate and placed at the recipient site.
Post-operative phase:
Follow-up visits are conducted at days 1, 3, 7, and 14, and at 1, 3, and 6 months post-surgery. At 1 month, healing abutments are placed and prosthetic treatment begins and impressions were taken 2 weeks later. In another 2 weeks, the final restorations were delivered. Keratinized mucosa changes are assessed using pre- and post-operative intraoral scans. Post-operative pain is evaluated using the Visual Analog Scale (VAS), and soft tissue aesthetic outcomes are assessed at 6 months using a standardized aesthetic score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Free Gingival Graft (FGG) | Experimental | Procedure: Conventional Free Gingival Graft (FGG) to increase keratinized mucosa around dental implantsA surgical procedure where a graft consisting of epithelium and connective tissue is harvested from the palate and transplanted to the peri-implant area to increase the width and height of keratinized mucosa |
| Combining a strip free gingival graft with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa | Experimental | Procedure: Combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa around dental implantsVenous blood is collected using a butterfly needle and 10ml tubes to prepare the PRF membrane. A keratinized mucosa strip of appropriate dimensions is harvested from the patient's palate. The strip free gingival graft and PRF membrane are then sutured and stabilized at the recipient site. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients meeting the following criteria are eligible for the study:
Key exclusion criteria (7 listed)
- Patients meeting any of the following criteria will be excluded from 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 |
|---|---|---|
| Combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa around dental implantsVenous blood is collected using a butterfly needle and 10ml tubes to prepare the PRF membrane. A keratinized mucosa strip of appropriate dimensions is harvested from the patient's palate. The strip free gingival graft and PRF membrane are then sutured and stabilized at the recipient site. | Procedure or surgery | Combining a strip free gingival graft with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa |
| Conventional Free Gingival Graft (FGG) to increase keratinized mucosa around dental implantsA surgical procedure where a graft consisting of epithelium and connective tissue is harvested from the palate and transplanted to the peri-implant area to increase the width and height of keratinized | Procedure or surgery | Conventional Free Gingival Graft (FGG) |
Primary outcome
Assessment of the increase in peri-implant keratinized mucosa width and mucosa thickness
Time frame: 1, 3, 6 months
KMW and MT were assessed using STL surface data at 1, 3, and 6 months
Soft tissue esthetics assessed by the modified Pink Esthetic Score (PES)
Time frame: 6 months post-operatively
"The esthetic outcome of the peri-implant soft tissue is evaluated using the modified Pink Esthetic Score (PES) as described by Fürhauser et al. (2005). The assessment compares the grafted area to the adjacent natural tooth based on parameters: Soft tissue color difference, soft tissue texture difference, soft tissue contour difference. Each parameter is assigned a score of 0, 1, or 2 (0 being the lowest, 2 being the highest/most esthetic). The total PES score ranges from 0 to 6, where a higher score indicates a superior esthetic result
Post-operative pain intensity measured by Visual Analog Scale (VAS)
Time frame: 1, 3, 7 and 14 days post-operatively
Pain intensity is measured on a Visual Analog Scale from 0 (no pain) to 10 (unbearable pain). Participants will be asked to mark their level of discomfort at each time point.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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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. This study is not recruiting at the moment.
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 Combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa around dental implants and Conventional Free Gingival Graft (FGG) to increase keratinized mucosa around dental implants in people with Dental Implants, run by University of Medicine and Pharmacy at Ho Chi Minh City 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 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: finished, as of the sponsor's last update on 20 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of the increase in peri-implant keratinized mucosa width and mucosa thickness (time frame: 1, 3, 6 months). The study lists 3 primary outcomes in all. 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 20 Jul 2026.