Papilla ReconstructionEarly Phase 1(PRF) (HA)NCT07280507
Comparing Microneedling and Injectable Platelet Rich Fibrin to Hyaluronic Acid In Papilla Reconstruction
A Early Phase 1 study testing Injectable Platelet Rich Fibrin and Hyaluronic Acid (HA) in people with Papilla Reconstruction, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
This randomized split-mouth clinical trial aims to compare the clinical effectiveness of microneedling combined with injectable platelet-rich fibrin (i-PRF) versus hyaluronic acid (HA) gel injection in the reconstruction of Class I interdental papilla loss. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Papilla Reconstruction
- What is being tested?
- Injectable Platelet Rich Fibrin and Hyaluronic Acid (HA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 24 Nov 2025to 30 Sep 2026
- Phase
- Early Phase 1
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Plaque index <1
- Gingival index <1
- Class I papillary loss (Nordland and Tarnow classification)
- Probing depth ≤4 mm at the test site
- Inter-proximal bone crest distance ≤7 mm from the contact point.
Who cannot join
- Pregnancy
- Lactation
- Uncontrolled systemic diseases (e.g., diabetes)
- Anticoagulant therapy
- Recent radiotherapy
- Orthodontic treatment
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- Midline diastema
- High frenum attachment
- Class II/III papillary loss.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Microneedling With Injectable PRF and Hyaluronic Acid for Papilla Reconstruction: A Randomized Clinical Trial
This randomized split-mouth clinical trial aims to compare the clinical effectiveness of microneedling combined with injectable platelet-rich fibrin (i-PRF) versus hyaluronic acid (HA) gel injection in the reconstruction of Class I interdental papilla loss. The study hypothesizes that MN + i-PRF will yield greater papillary regeneration, offering a minimally invasive, biologically active alternative to traditional surgical approaches for soft-tissue esthetic rehabilitation.
- Conditions
- Papilla Reconstruction
- Being tested
- Injectable Platelet Rich Fibrin, Hyaluronic Acid (HA)
- Keywords
- Papilla, Reconstruction, Hyaluronic Acid, Injectable Platelet Rich Fibrin, Microneedling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable Platelet Rich FibrinBiological
Injectable Platelet Rich Fibrin
Hyaluronic Acid (HA)Other
Filler
| Study group | Role | What they receive |
|---|---|---|
| HA | Experimental | Hyaluronic Acid Filler Receives: Other: Hyaluronic Acid (HA) |
| iPRF | Active comparator | Not described Receives: Biological: Injectable Platelet Rich Fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Papillary height
from the mucogingival junction to the papilla tip
Measured: Baseline, 6 weeks, and 12 weeks.
Papillary width
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start24 Nov 2025
- Primary completionMar 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papilla ReconstructionStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Jamjoom, BDS, MS., King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280507
- Sponsor's protocol ID
- 117-10-24
- Other IDs
- 117-10-24, 117-10-24, King AbdulAziz University
- Acronym
- (PRF) (HA)
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Microneedling With Injectable PRF and Hyaluronic Acid for Papilla Reconstruction: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07280507
- Acronym / sponsor ID
- (PRF) (HA) / 117-10-24
- Conditions
- Papilla Reconstruction
- Keywords
- Papilla, Reconstruction, Hyaluronic Acid, Injectable Platelet Rich Fibrin, Microneedling
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 12 Dec 2025 (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 split-mouth clinical trial aims to compare the clinical effectiveness of microneedling combined with injectable platelet-rich fibrin (i-PRF) versus hyaluronic acid (HA) gel injection in the reconstruction of Class I interdental papilla loss. The study hypothesizes that MN + i-PRF will yield greater papillary regeneration, offering a minimally invasive, biologically active alternative to traditional surgical approaches for soft-tissue esthetic rehabilitation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA | Experimental | Other: Hyaluronic Acid (HA)Hyaluronic Acid Filler |
| iPRF | Active comparator | Biological: Injectable Platelet Rich Fibrin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Plaque index <1
- Gingival index <1
- Class I papillary loss (Nordland and Tarnow classification)
- Probing depth ≤4 mm at the test site
- Inter-proximal bone crest distance ≤7 mm from the contact point.
Key exclusion criteria (9 listed)
- Pregnancy
- Lactation
- Uncontrolled systemic diseases (e.g., diabetes)
- Anticoagulant therapy
- Recent radiotherapy
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 |
|---|---|---|
| Injectable Platelet Rich FibrinInjectable Platelet Rich Fibrin | Biological | iPRF |
| Hyaluronic Acid (HA)Filler | Other | HA |
Primary outcome
Papillary height
Time frame: Baseline, 6 weeks, and 12 weeks.
from the mucogingival junction to the papilla tip
Papillary width
Time frame: 12 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 12 Dec 2025.
- Individual participant dataSharing planned: Yes
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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 Early Phase 1 study testing Injectable Platelet Rich Fibrin and Hyaluronic Acid (HA) in people with Papilla Reconstruction, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 9 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: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2025. 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 Saudi Arabia. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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?
Papillary height (time frame: Baseline, 6 weeks, and 12 weeks.). The study lists 2 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 12 Dec 2025.