Thin Peri-implant Mucosal PhenotypeNCT07667855
Peri-implant Soft Tissue Augmentation Using Microneedling With i-PRF vs. Connective Tissue Graft
A study testing Connective Tissue Graft (CTG) and Microneedling with Injectable Platelet-Rich Fibrin (MN+i-PRF) in people with Thin Peri-implant Mucosal Phenotype, run by Beirut Arab University at 1 site in Lebanon.
Trial summary
This randomized controlled clinical trial aims to evaluate a minimally invasive technique for peri-implant soft tissue augmentation using microneedling combined with injectable platelet-rich fibrin (i-PRF) compared with the current gold-standard connective tissue graft (CTG). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thin Peri-implant Mucosal Phenotype
- What is being tested?
- Connective Tissue Graft (CTG) and Microneedling with Injectable Platelet-Rich Fibrin (MN+i-PRF)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteLebanon
- Study dates
- 26 Jun 2026to 26 Mar 2027
- 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
- Systemically healthy adults (Between 18 and 65) with one or more dental implants requiring second-stage surgery in the esthetic zone (Anteriors and Premolars).
- Thin soft tissue phenotype: mucosal thickness or KTW <2 mm buccally.
- Stable osseointegrated implant, adequate restorative space, and healthy adjacent teeth.
- Good oral hygiene (PI ≤10%), with peri-implant maintenance.
- Signed consent + willingness for 1-year follow-up.
Who cannot join
- Heavy smokers (≥10 cig/day); light smokers only if reduced.
- Systemic/healing issues: uncontrolled diabetes, immunocompromise, bleeding disorders, anticoagulants, steroids.
- Pregnancy or breastfeeding.
- Active infection (periodontal or peri-implant).
- No residual keratinized mucosa on buccal side.
- Previous graft/augmentation at the site or recent surgery (<6 months).
- Allergies to anesthetics/materials.
- Non-compliance with instructions or follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site
Beirut Arab University
Beirut
Nayer Aboelsaad, Phd, +96179109899, naier74@gmail.com
About this study
Official title: Peri-implant Soft Tissue Augmentation Using Microneedling With i-PRF vs. Connective Tissue Graft: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial aims to evaluate a minimally invasive technique for peri-implant soft tissue augmentation using microneedling combined with injectable platelet-rich fibrin (i-PRF) compared with the current gold-standard connective tissue graft (CTG). Patients with thin peri-implant soft tissue requiring implant second-stage surgery in the esthetic zone will be randomly assigned to receive either CTG harvested from the palate or a series of microneedling and i-PRF treatments. Clinical outcomes including mucosal thickness, keratinized tissue width, peri-implant health parameters, volumetric soft tissue changes, esthetic outcomes, and patient-reported measures of pain and satisfaction will be evaluated during follow-up. The study aims to determine whether microneedling with i-PRF can provide comparable soft tissue augmentation while reducing patient morbidity associated with connective tissue graft harvesting.
Read the detailed description
Peri-implant soft tissue quality is a key determinant of implant health, long-term stability, and esthetic outcomes. Adequate peri-implant mucosal thickness and keratinized tissue width contribute to the maintenance of peri-implant health, while thin soft tissue phenotypes have been associated with increased risk of recession, discomfort during oral hygiene procedures, and peri-implant tissue complications. Connective tissue grafting (CTG) remains the gold standard for peri-implant soft tissue augmentation; however, it requires harvesting autogenous tissue from a secondary donor site, resulting in increased surgical morbidity, postoperative discomfort, and longer treatment time.
Recent regenerative approaches have focused on the use of injectable platelet-rich fibrin (i-PRF), an autologous blood-derived concentrate rich in platelets, leukocytes, fibrin, and growth factors that promote angiogenesis, collagen formation, and soft tissue healing. Microneedling is a minimally invasive technique that creates controlled micro-injuries within the soft tissues, stimulating collagen production and enhancing the penetration and biological effects of regenerative agents. Preliminary evidence suggests that combining microneedling with i-PRF may enhance peri-implant soft tissue thickness and quality while minimizing patient morbidity.
This study is designed as a prospective, parallel-arm randomized controlled clinical trial comparing microneedling combined with injectable platelet-rich fibrin (MN+i-PRF) with connective tissue grafting (CTG) for peri-implant soft tissue augmentation during implant second-stage surgery. Approximately 24 eligible participants presenting with thin peri-implant soft tissue phenotype in the esthetic zone will be randomly allocated in a 1:1 ratio to either the test or control group. Allocation concealment will be performed using computer-generated randomization and sealed opaque envelopes. Outcome assessors will be blinded to treatment allocation.
Participants in the control group will undergo peri-implant soft tissue augmentation using a subepithelial connective tissue graft harvested from the palate and stabilized at the buccal aspect of the implant site. Participants in the test group will receive microneedling using a sterile automated microneedling device followed by injection of autologous i-PRF into the peri-implant mucosa. The test intervention will be performed at implant uncovery and repeated at 2-week and 4-week follow-up visits to maximize regenerative effects.
The primary outcome measure will be the change in peri-implant mucosal thickness from baseline. Secondary outcome measures will include keratinized tissue width, peri-implant probing depth, bleeding on probing, volumetric soft tissue contour changes assessed through intraoral scanning, Pink Esthetic Score (PES), and patient-reported outcome measures including postoperative pain and treatment satisfaction. Clinical and patient-centered outcomes will be evaluated at predefined follow-up intervals extending up to 9 months after treatment.
The objective of this study is to determine whether microneedling combined with i-PRF can provide peri-implant soft tissue augmentation outcomes comparable to connective tissue grafting while reducing treatment invasiveness and patient morbidity. The findings may contribute to the development of minimally invasive regenerative approaches for peri-implant phenotype modification and esthetic enhancement.
- Conditions
- Thin Peri-implant Mucosal Phenotype
- Being tested
- Connective Tissue Graft (CTG), Microneedling with Injectable Platelet-Rich Fibrin (MN+i-PRF)
- Keywords
- Microneedling, Injectable Platelet-Rich Fibrin, i-PRF, Peri-implant soft tissue augmentation, Implant Esthetics, Mucosal Thickness, Connective Tissue Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective Tissue Graft (CTG)Procedure or surgery
Peri-implant soft tissue augmentation performed using a subepithelial connective tissue graft harvested from the palate during implant second-stage surgery. The graft is placed at the buccal aspect of the implant site to increase mucosal thickness and improve peri-implant soft tissue phenotype.
Microneedling with Injectable Platelet-Rich Fibrin (MN+i-PRF)Procedure or surgery
Peri-implant soft tissue augmentation performed using automated microneedling followed by injection of autologous injectable platelet-rich fibrin (i-PRF) during implant second-stage surgery. The intervention is repeated at 2 and 4 weeks postoperatively to enhance peri-implant soft tissue thickness and quality.
| Study group | Role | What they receive |
|---|---|---|
| Connective Tissue Graft | Active comparator | Participants will receive peri-implant soft tissue augmentation using a subepithelial connective tissue graft harvested from the palate during implant second-stage surgery. The graft will be placed at the buccal aspect of the implant site to increase peri-implant mucosal thickness and improve soft tissue phenotype stability. Receives: Procedure: Connective Tissue Graft (CTG) |
| Microneedling + Injectable Platelet-Rich Fibrin (MN+i-PRF) | Experimental | Participants will receive peri-implant soft tissue augmentation using microneedling with a sterile automated microneedling device followed by injection of autologous injectable platelet-rich fibrin (i-PRF). The procedure will be performed during implant second-stage surgery and repeated at 2 and 4 weeks postoperatively. Receives: Procedure: Microneedling with Injectable Platelet-Rich Fibrin (MN+i-PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal Thickness
Change in buccal peri-implant mucosal thickness (mm) measured at the mid-facial aspect, 2 mm apical to the mucosal margin, using standardized transgingival probing through a custom stent. Measurements will be compared between baseline and follow-up examinations.
Measured: Baseline to 8 Weeks
Secondary outcomes (7)
Keratinized Tissue Width (KTW)
Change in keratinized tissue width (mm) measured at the mid-facial aspect from the mucosal margin to the mucogingival junction using a calibrated periodontal probe.
Measured: Baseline to 8 Weeks
Peri-implant Probing Depth (PD)
Peri-implant probing depth (mm) measured at four sites per implant (mesiobuccal, mid-buccal, distobuccal, and lingual/palatal) using a calibrated periodontal probe and standardized probing force.
Measured: Baseline to 8 Weeks
Bleeding on Probing (BOP)
Presence or absence of bleeding following gentle periodontal probing at four peri-implant sites. Bleeding on probing will be recorded as an indicator of peri-implant soft tissue health.
Measured: Baseline to 8 Weeks
Volumetric Soft Tissue Contour Change
Volumetric changes in peri-implant soft tissues assessed using intraoral digital scans and three-dimensional superimposition of STL files obtained at baseline and follow-up visits.
Measured: Baseline to 8 weeks
Pink Esthetic Score (PES)
Esthetic evaluation of peri-implant soft tissues using the Pink Esthetic Score. Standardized clinical photographs will be assessed to evaluate papilla fill, soft tissue contour, level, color, and texture around the implant restoration.
Measured: 6 Months
Postoperative Pain
Participant-reported postoperative pain measured using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
Measured: 24 Hours and 72 Hours Postoperatively
Patient Satisfaction
Participant satisfaction regarding treatment comfort, esthetic outcome, and willingness to undergo the procedure again, measured using a 10-point Visual Analog Scale (VAS).
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start26 Jun 2026 (estimated)
- Primary completion26 Feb 2027 (estimated)
- Study completion26 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Thin Peri-implant Mucosal PhenotypeStudies 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 study is a prospective, parallel-arm, randomized controlled clinical trial. Eligible participants requiring peri-implant soft tissue augmentation during second-stage implant surgery will be randomly assigned in a 1:1 ratio to either a connective tissue graft (CTG) group or a microneedling with injectable platelet-rich fibrin (MN+i-PRF) group. Participants will remain in their assigned group throughout the study, and outcomes will be evaluated over a 9-month follow-up period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beirut Arab University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayer Aboelsaad, Beirut Arab University
- Investigators
- Nayer Aboelsaad, PHD, Study chair, Beirut Arab University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667855
- Sponsor's protocol ID
- 2025-H-0185-D-M-0914
- Status last verified
- Oct 2025
- First submitted
- 19 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ayyildiz BG, Eken S, Terzioglu B. The effect of the injectable platelet-rich fibrin on peri-implant soft tissue phenotype: a preliminary, prospective, 12-month follow-up clinical study. Clin Oral Investig. 2026 Mar 30;30(4):159. doi: 10.1007/s00784-026-06849-0.
PubMed 41910803Giammarinaro E, Baldini N, Covani U, Menini M, Pesce P, Marconcini S. Does platelet-rich fibrin enhance the outcomes of peri-implant soft tissues? A systematic review. BMC Oral Health. 2025 Apr 22;25(1):615. doi: 10.1186/s12903-025-05922-6.
PubMed 40264081Zurek J, Niemczyk W, Dominiak M, Niemczyk S, Wiench R, Skaba D. Gingival Augmentation Using Injectable Platelet-Rich Fibrin (i-PRF)-A Systematic Review of Randomized Controlled Trials. J Clin Med. 2024 Sep 20;13(18):5591. doi: 10.3390/jcm13185591.
PubMed 39337077Chetana, Sidharthan S, Dharmarajan G, Iyer S, Poulose M, Guruprasad M, Chordia D. Evaluation of microneedling with and without injectable-platelet rich fibrin for gingival augmentation in thin gingival phenotype-A randomized clinical trial. J Oral Biol Craniofac Res. 2024 Jan-Feb;14(1):49-54. doi: 10.1016/j.jobcr.2023.10.008. Epub 2023 Dec 15.
PubMed 38188907Valli Veluri S, Gottumukkala SN, Penmetsa GS, Ramesh K, P MK, Bypalli V, Vundavalli S, Gera D. Clinical and patient-reported outcomes of periodontal phenotype modification therapy using injectable platelet rich fibrin with microneedling and free gingival grafts: A prospective clinical trial. J Stomatol Oral Maxillofac Surg. 2024 Sep;125(4):101744. doi: 10.1016/j.jormas.2023.101744. Epub 2023 Dec 19.
PubMed 38128879
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-implant Soft Tissue Augmentation Using Microneedling With i-PRF vs. Connective Tissue Graft: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07667855
- Acronym / sponsor ID
- 2025-H-0185-D-M-0914
- Conditions
- Thin Peri-implant Mucosal Phenotype
- Keywords
- Microneedling, Injectable Platelet-Rich Fibrin, i-PRF, Peri-implant soft tissue augmentation, Implant Esthetics, Mucosal Thickness, Connective Tissue Graft
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Beirut Arab UniversityUniversity, hospital or other
- Study start
- 26 Jun 2026 (estimated)
- Primary completion
- 26 Feb 2027 (estimated)
- Study completion
- 26 Mar 2027 (estimated)
- First posted
- 25 Jun 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 clinical trial aims to evaluate a minimally invasive technique for peri-implant soft tissue augmentation using microneedling combined with injectable platelet-rich fibrin (i-PRF) compared with the current gold-standard connective tissue graft (CTG). Patients with thin peri-implant soft tissue requiring implant second-stage surgery in the esthetic zone will be randomly assigned to receive either CTG harvested from the palate or a series of microneedling and i-PRF treatments. Clinical outcomes including mucosal thickness, keratinized tissue width, peri-implant health parameters, volumetric soft tissue changes, esthetic outcomes, and patient-reported measures of pain and satisfaction will be evaluated during follow-up. The study aims to determine whether microneedling with i-PRF can provide comparable soft tissue augmentation while reducing patient morbidity associated with connective tissue graft harvesting.
Detailed description
Peri-implant soft tissue quality is a key determinant of implant health, long-term stability, and esthetic outcomes. Adequate peri-implant mucosal thickness and keratinized tissue width contribute to the maintenance of peri-implant health, while thin soft tissue phenotypes have been associated with increased risk of recession, discomfort during oral hygiene procedures, and peri-implant tissue complications. Connective tissue grafting (CTG) remains the gold standard for peri-implant soft tissue augmentation; however, it requires harvesting autogenous tissue from a secondary donor site, resulting in increased surgical morbidity, postoperative discomfort, and longer treatment time.
Recent regenerative approaches have focused on the use of injectable platelet-rich fibrin (i-PRF), an autologous blood-derived concentrate rich in platelets, leukocytes, fibrin, and growth factors that promote angiogenesis, collagen formation, and soft tissue healing. Microneedling is a minimally invasive technique that creates controlled micro-injuries within the soft tissues, stimulating collagen production and enhancing the penetration and biological effects of regenerative agents. Preliminary evidence suggests that combining microneedling with i-PRF may enhance peri-implant soft tissue thickness and quality while minimizing patient morbidity.
This study is designed as a prospective, parallel-arm randomized controlled clinical trial comparing microneedling combined with injectable platelet-rich fibrin (MN+i-PRF) with connective tissue grafting (CTG) for peri-implant soft tissue augmentation during implant second-stage surgery. Approximately 24 eligible participants presenting with thin peri-implant soft tissue phenotype in the esthetic zone will be randomly allocated in a 1:1 ratio to either the test or control group. Allocation concealment will be performed using computer-generated randomization and sealed opaque envelopes. Outcome assessors will be blinded to treatment allocation.
Participants in the control group will undergo peri-implant soft tissue augmentation using a subepithelial connective tissue graft harvested from the palate and stabilized at the buccal aspect of the implant site. Participants in the test group will receive microneedling using a sterile automated microneedling device followed by injection of autologous i-PRF into the peri-implant mucosa. The test intervention will be performed at implant uncovery and repeated at 2-week and 4-week follow-up visits to maximize regenerative effects.
The primary outcome measure will be the change in peri-implant mucosal thickness from baseline. Secondary outcome measures will include keratinized tissue width, peri-implant probing depth, bleeding on probing, volumetric soft tissue contour changes assessed through intraoral scanning, Pink Esthetic Score (PES), and patient-reported outcome measures including postoperative pain and treatment satisfaction. Clinical and patient-centered outcomes will be evaluated at predefined follow-up intervals extending up to 9 months after treatment.
The objective of this study is to determine whether microneedling combined with i-PRF can provide peri-implant soft tissue augmentation outcomes comparable to connective tissue grafting while reducing treatment invasiveness and patient morbidity. The findings may contribute to the development of minimally invasive regenerative approaches for peri-implant phenotype modification and esthetic enhancement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a prospective, parallel-arm, randomized controlled clinical trial. Eligible participants requiring peri-implant soft tissue augmentation during second-stage implant surgery will be randomly assigned in a 1:1 ratio to either a connective tissue graft (CTG) group or a microneedling with injectable platelet-rich fibrin (MN+i-PRF) group. Participants will remain in their assigned group throughout the study, and outcomes will be evaluated over a 9-month follow-up period.
| Arm | Type | Receives |
|---|---|---|
| Connective Tissue Graft | Active comparator | Procedure: Connective Tissue Graft (CTG)Participants will receive peri-implant soft tissue augmentation using a subepithelial connective tissue graft harvested from the palate during implant second-stage surgery. The graft will be placed at the buccal aspect of the implant site to increase peri-implant mucosal thickness and improve soft tissue phenotype stability. |
| Microneedling + Injectable Platelet-Rich Fibrin (MN+i-PRF) | Experimental | Procedure: Microneedling with Injectable Platelet-Rich Fibrin (MN+i-PRF)Participants will receive peri-implant soft tissue augmentation using microneedling with a sterile automated microneedling device followed by injection of autologous injectable platelet-rich fibrin (i-PRF). The procedure will be performed during implant second-stage surgery and repeated at 2 and 4 weeks postoperatively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Systemically healthy adults (Between 18 and 65) with one or more dental implants requiring second-stage surgery in the esthetic zone (Anteriors and Premolars).
- Thin soft tissue phenotype: mucosal thickness or KTW <2 mm buccally.
- Stable osseointegrated implant, adequate restorative space, and healthy adjacent teeth.
- Good oral hygiene (PI ≤10%), with peri-implant maintenance.
- Signed consent + willingness for 1-year follow-up.
Key exclusion criteria (8 listed)
- Heavy smokers (≥10 cig/day); light smokers only if reduced.
- Systemic/healing issues: uncontrolled diabetes, immunocompromise, bleeding disorders, anticoagulants, steroids.
- Pregnancy or breastfeeding.
- Active infection (periodontal or peri-implant).
- No residual keratinized mucosa on buccal side.
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 Graft (CTG)Peri-implant soft tissue augmentation performed using a subepithelial connective tissue graft harvested from the palate during implant second-stage surgery. The graft is placed at the buccal aspect of the implant site to increase mucosal thickness and improve peri-implant soft tissue phenotype. | Procedure or surgery | Connective Tissue Graft |
| Microneedling with Injectable Platelet-Rich Fibrin (MN+i-PRF)Peri-implant soft tissue augmentation performed using automated microneedling followed by injection of autologous injectable platelet-rich fibrin (i-PRF) during implant second-stage surgery. The intervention is repeated at 2 and 4 weeks postoperatively to enhance peri-implant soft tissue thickness and quality. | Procedure or surgery | Microneedling + Injectable Platelet-Rich Fibrin (MN+i-PRF) |
Primary outcome
Mucosal Thickness
Time frame: Baseline to 8 Weeks
Change in buccal peri-implant mucosal thickness (mm) measured at the mid-facial aspect, 2 mm apical to the mucosal margin, using standardized transgingival probing through a custom stent. Measurements will be compared between baseline and follow-up examinations.
7 secondary outcomes
Keratinized Tissue Width (KTW)
Time frame: Baseline to 8 Weeks
Peri-implant Probing Depth (PD)
Time frame: Baseline to 8 Weeks
Bleeding on Probing (BOP)
Time frame: Baseline to 8 Weeks
Volumetric Soft Tissue Contour Change
Time frame: Baseline to 8 weeks
Pink Esthetic Score (PES)
Time frame: 6 Months
Postoperative Pain
Time frame: 24 Hours and 72 Hours Postoperatively
Patient Satisfaction
Time frame: 8 Weeks
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 25 Jun 2026.
- Results publication: PubMed 41910803Ayyildiz BG, Eken S, Terzioglu B. The effect of the injectable platelet-rich fibrin on peri-implant soft tissue phenotype: a preliminary, prospective, 12-month follow-up clinical study. Clin Oral Investig. 2026 Mar 30;30(4):159. doi: 10.1007/s00784-026-06849-0.
- Results publication: PubMed 40264081Giammarinaro E, Baldini N, Covani U, Menini M, Pesce P, Marconcini S. Does platelet-rich fibrin enhance the outcomes of peri-implant soft tissues? A systematic review. BMC Oral Health. 2025 Apr 22;25(1):615. doi: 10.1186/s12903-025-05922-6.
- Results publication: PubMed 39337077Zurek J, Niemczyk W, Dominiak M, Niemczyk S, Wiench R, Skaba D. Gingival Augmentation Using Injectable Platelet-Rich Fibrin (i-PRF)-A Systematic Review of Randomized Controlled Trials. J Clin Med. 2024 Sep 20;13(18):5591. doi: 10.3390/jcm13185591.
- Results publication: PubMed 38188907Chetana, Sidharthan S, Dharmarajan G, Iyer S, Poulose M, Guruprasad M, Chordia D. Evaluation of microneedling with and without injectable-platelet rich fibrin for gingival augmentation in thin gingival phenotype-A randomized clinical trial. J Oral Biol Craniofac Res. 2024 Jan-Feb;14(1):49-54. doi: 10.1016/j.jobcr.2023.10.008. Epub 2023 Dec 15.
- Results publication: PubMed 38128879Valli Veluri S, Gottumukkala SN, Penmetsa GS, Ramesh K, P MK, Bypalli V, Vundavalli S, Gera D. Clinical and patient-reported outcomes of periodontal phenotype modification therapy using injectable platelet rich fibrin with microneedling and free gingival grafts: A prospective clinical trial. J Stomatol Oral Maxillofac Surg. 2024 Sep;125(4):101744. doi: 10.1016/j.jormas.2023.101744. Epub 2023 Dec 19.
- Individual participant dataSharing planned: Undecided
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.
Nayer Aboelsaad, PHD study chair
Beirut Arab University
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 (CTG) and Microneedling with Injectable Platelet-Rich Fibrin (MN+i-PRF) in people with Thin Peri-implant Mucosal Phenotype, run by Beirut Arab University at 1 site in Lebanon.
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 8 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 25 Jun 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 Lebanon. 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 Ranim Ahmad, Msc Oral & Dental Surgery (+961 79129351, raneem-ahmad1998@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucosal Thickness (time frame: Baseline to 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07667855, which also lists 5 linked publications.
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 25 Jun 2026.