Peri-implant Mucosa ThicknessPhase 2/3NCT07750756
Hyaluronic Acid vs I-PRF With Microneedling in Enhancing Peri-implant Soft Tissue
A Phase 2/3 study testing Hyaluronic Acid (HA) and Platelet rich fibrin in people with Peri-implant Mucosa Thickness, run by Ain Shams University.
Trial summary
This study aims to compare the use of microneedling alone versus with hyaluronic acid or i-PRF in conjunction with microneedling in peri-implant mucosa in the esthetic zone to test the superior increase in gingival thickness. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Peri-implant Mucosa Thickness
- What is being tested?
- Hyaluronic Acid (HA) and Platelet rich fibrin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 30 May 2028
- Phase
- Phase 2/3
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with delayed implants placed in the maxillary esthetic region in correct positioning and angulation
- Patients with peri-implant gingival thickness ≤ 1 mm
- Patients with healthy gingiva and who can maintain good oral hygiene around implants
Who cannot join
- Marginal bone loss ≤ 2 mm
- Patients with peri-implantitis or periodontitis
- Patients with systemic conditions or diseases impairing healing or soft tissue metabolism
- Pregnant or lactating females
- Patients taking medications affecting the gingiva
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Hyaluronic Acid Versus I-PRF Combined With Microneedling for Peri Implant Soft Tissue Enhancement: A Randomized Controlled Clinical Trial
This study aims to compare the use of microneedling alone versus with hyaluronic acid or i-PRF in conjunction with microneedling in peri-implant mucosa in the esthetic zone to test the superior increase in gingival thickness.
Read the detailed description
Despite the rising demand for esthetics and the prevailing use of dental implants in the recent era, the soft tissue remains a dilemma that affects patients' satisfaction and the implants' longevity in the oral environment, especially in the esthetic region of the maxilla. Various studies have been done to test the effectiveness of microneedling, hyaluronic acid, and i-PRF as alternative non-invasive or minimally invasive methods targeting tissue enhancement in the gingiva, and have proven that they have notable and desirable results. However, there is a lack in the literature regarding the use of these previously mentioned treatment options with regard to peri-implant soft tissue, and which of the delivered solutions offers superior results with reference to peri-implant mucosa in conjunction with microneedling.
- Conditions
- Peri-implant Mucosa Thickness
- Being tested
- Hyaluronic Acid (HA), Platelet rich fibrin
- Keywords
- microneedling, hyaluronic acid, I-PRF, gingival thickness, peri-implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid (HA)Drug
Hyaluronic acid (HA) is a genuine linear glycosaminoglycan that is present within the extracellular matrix of connective, epithelial, and neural tissues.
Platelet rich fibrinBiological
Also called (I-PRF)
Injectable PRF (i-PRF) is a notable method in enhancing soft tissue phenotypes, relying on its injectable form that can be well delivered to targeted areas to ensure proper distribution of growth factors and cytokines.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling | No intervention | microneedling into the peri-implant soft tissue site |
| Microneedling with Hyaluronic Acid (HA) | Experimental | Microneedling into the peri-implant soft tissue site in addition to the use of HA, repeated 3 times with 7 days gap in between. Receives: Drug: Hyaluronic Acid (HA) |
| Microneedling with injectable platelet rich fibrin (I-PRF) | Experimental | Microneedling into the peri-implant soft tissue site, in addition to the use of I-PRF, repeated 3 times with 7 days gap in between. Receives: Biological: Platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant gingival thickness
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 posted6 Aug 2026
- Study start30 Oct 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion30 May 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 Mucosa ThicknessStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahaf Medhat Zayn, Ain Shams University
- Investigators
- Doaa A. Khattab, Associate Professor, Study chair, Ain Shams UniveristySuzan Sarhan, Associate Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750756
- Sponsor's protocol ID
- 1673
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyaluronic Acid Versus I-PRF Combined With Microneedling for Peri Implant Soft Tissue Enhancement: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07750756
- Acronym / sponsor ID
- 1673
- Conditions
- Peri-implant Mucosa Thickness
- Keywords
- microneedling, hyaluronic acid, I-PRF, gingival thickness, peri-implant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 6 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.
This study aims to compare the use of microneedling alone versus with hyaluronic acid or i-PRF in conjunction with microneedling in peri-implant mucosa in the esthetic zone to test the superior increase in gingival thickness.
Detailed description
Despite the rising demand for esthetics and the prevailing use of dental implants in the recent era, the soft tissue remains a dilemma that affects patients' satisfaction and the implants' longevity in the oral environment, especially in the esthetic region of the maxilla. Various studies have been done to test the effectiveness of microneedling, hyaluronic acid, and i-PRF as alternative non-invasive or minimally invasive methods targeting tissue enhancement in the gingiva, and have proven that they have notable and desirable results. However, there is a lack in the literature regarding the use of these previously mentioned treatment options with regard to peri-implant soft tissue, and which of the delivered solutions offers superior results with reference to peri-implant mucosa in conjunction with microneedling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Microneedling | No intervention | –microneedling into the peri-implant soft tissue site |
| Microneedling with Hyaluronic Acid (HA) | Experimental | Drug: Hyaluronic Acid (HA)Microneedling into the peri-implant soft tissue site in addition to the use of HA, repeated 3 times with 7 days gap in between. |
| Microneedling with injectable platelet rich fibrin (I-PRF) | Experimental | Biological: Platelet rich fibrinMicroneedling into the peri-implant soft tissue site, in addition to the use of I-PRF, repeated 3 times with 7 days gap in between. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with delayed implants placed in the maxillary esthetic region in correct positioning and angulation
- Patients with peri-implant gingival thickness ≤ 1 mm
- Patients with healthy gingiva and who can maintain good oral hygiene around implants
Key exclusion criteria (5 listed)
- Marginal bone loss ≤ 2 mm
- Patients with peri-implantitis or periodontitis
- Patients with systemic conditions or diseases impairing healing or soft tissue metabolism
- Pregnant or lactating females
- Patients taking medications affecting the gingiva
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 |
|---|---|---|
| Hyaluronic Acid (HA)Hyaluronic acid (HA) is a genuine linear glycosaminoglycan that is present within the extracellular matrix of connective, epithelial, and neural tissues. | Drug | Microneedling with Hyaluronic Acid (HA) |
| Platelet rich fibrinAlso: (I-PRF)Injectable PRF (i-PRF) is a notable method in enhancing soft tissue phenotypes, relying on its injectable form that can be well delivered to targeted areas to ensure proper distribution of growth factors and cytokines. | Biological | Microneedling with injectable platelet rich fibrin (I-PRF) |
Primary outcome
Peri-implant gingival thickness
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 17 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Peri-implant Mucosa Thickness
Not yet recruitingObservational study
Association Between Peri-implant Soft Tissue Thickness and Midfacial Marginal Mucosal Recession
Midfacial Mucosal Recession
Not yet recruiting
Peri-implant Soft Tissue Augmentation Using Microneedling With i-PRF vs. Connective Tissue Graft
Thin Peri-implant Mucosal Phenotype
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.
Doaa A. Khattab, Associate Professor study chair
Ain Shams Univeristy
Suzan Sarhan, Associate Professor study director
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hyaluronic Acid (HA) and Platelet rich fibrin in people with Peri-implant Mucosa Thickness, run by Ain Shams University.
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 3 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: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rahaf A. Khattab, Principal investigator (+201120008982, RahafZayn@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant gingival thickness (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 17 Aug 2026.