Single RT1 Gingival Recession With no Loss of Interproximal AttachmentPhase 1/2NCT07520539
Adding Effect of Cross-linked Hyaluronic Acid to Microneedling After Coronally Advanced Flap in Isolated RT1 Recession
A Phase 1/2 study testing cross-linked hyaluronic acid and Microneedling in people with Single RT1 Gingival Recession With no Loss of Interproximal Attachment, run by Cairo University.
Trial summary
In patients with single RT1 recessions and thin gingival phenotype, does adding cross-linked hyaluronic acid by microneedling after CAF surgery produce greater gingival thickness gain and higher probability of complete root coverage at 6 months than microneedling alone? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Single RT1 Gingival Recession With no Loss of Interproximal Attachment
- What is being tested?
- cross-linked hyaluronic acid and Microneedling
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Dec 2026
- Phase
- Phase 1/2
- 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
- Inclusion criteria
- Adult (≥18 years) with Single RT1 gingival recession in esthetic zone.
- Thin gingival biotype (≤ 1mm).
- Systemically healthy patients.
- Non- smoker patients.
- Full-mouth bleeding on probing (BOP) and plaque indices (PI) scores ≤15%.
- Willingness to comply with follow up and maintenance.
- Exclusion criteria
- RT2 or RT3 recessions or multiple adjacent recessions.
- Previous mucogingival surgery at the test site.
- Use of medications causing gingival enlargement.
- Uncontrolled systemic disease.
- Pregnancy or lactation.
- Current smokers.
About this study
Official title: Evaluation of Gingival Thickness and Root Coverage Outcomes Following Coronally Advanced Flap Combined With Microneedling With or Without Cross-Linked Hyaluronic Acid in RT1 Recession Defects: A Randomized Clinical Trial
In patients with single RT1 recessions and thin gingival phenotype, does adding cross-linked hyaluronic acid by microneedling after CAF surgery produce greater gingival thickness gain and higher probability of complete root coverage at 6 months than microneedling alone?
Read the detailed description
The aim of this study is to evaluate changes in gingival thickness and root coverage outcomes after coronally advanced flap (CAF) then cross-linked hyaluronic acid injection along with performing microneedling in patients with RT1 single gingival recession with thin gingival phenotype in esthetic region.
- Being tested
- cross-linked hyaluronic acid, Microneedling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross-linked hyaluronic acidCombination product
Microneedling sessions will be performed 1 month after the CAF procedure to ensure initial flap healing. The micro-needling technique will be performed under local anesthesia, by using Dr. Pen Ultima M8 MN pen (Dr. Pen; Phoenix, AZ, USA) using 16-Pins gauge with a diameter of 0.18 mm adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. The MN needles are vertically inserted into the keratinized tissue reaching the bone, for 30-40 s per tooth using an intermittent motion along the keratinized tissue. Then, cross-linked hyaluronic acid will be injected in a volume of 0.2mm of a 20 mg/ml concentration with particle size 400 μm. HA injection will be administrated until blanching of gingiva is evident. To ascertain that the HA is distributed evenly, the region will be gently massaged for 2 to 3 min with a sterile gauze soaked in saline. This Microneedling technique with HA injection will be repeated four times at 10-day intervals.
MicroneedlingDevice
Microneedling sessions will be performed 1 month after CAF procedure to ensure initial flap healing. The micro-needling technique will be performed under local anesthesia, by using Dr. Pen Ultima M8 MN pen (Dr. Pen; Phoenix, AZ, USA) using 16-Pins gauge with a diameter of 0.18 mm adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. The MN needles are vertically inserted into the keratinized tissue reaching the bone, for 30-40 s per tooth using an intermittent motion along the keratinized tissue. This method will be repeated four times at 10-day intervals.
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Microneedling sessions will be performed 1 month after the CAF procedure to ensure initial flap healing. The micro-needling technique will be performed under local anesthesia, by using Dr. Pen Ultima M8 MN pen (Dr. Pen; Phoenix, AZ, USA) using 16-Pins gauge with a diameter of 0.18 mm adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. The MN needles are vertically inserted into the keratinized tissue reaching the bone, for 30-40 s per tooth using an intermittent motion along the keratinized tissue. Then, cross-linked hyaluronic acid will be injected in a volume of 0.2mm of a 20 mg/ml concentration with particle size 400 μm. HA injection will be administrated until blanching of gingiva is evident. To ascertain that the HA is distributed evenly the region will be gently massaged for 2 to 3 min with a sterile gauze soaked in saline. This Microneedling technique with HA injection will be repeated four times at 10-day intervals. Receives: Combination Product: cross-linked hyaluronic acid |
| control group | Active comparator | Microneedling sessions will be performed 1 month after CAF procedure to ensure initial flap healing. The micro-needling technique will be performed under local anesthesia, by using Dr. Pen Ultima M8 MN pen (Dr. Pen; Phoenix, AZ, USA) using 16-Pins gauge with a diameter of 0.18 mm adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. The MN needles are vertically inserted into the keratinized tissue reaching the bone, for 30-40 s per tooth using an intermittent motion along the keratinized tissue. This method will be repeated four times at 10-day intervals. Receives: Device: Microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival thickness
using a No.15 endodontic spreader with a silicon stopper placed 2 mm apical to the gingival margin at the mid-buccal aspect; depth of penetration measured with a ruler to the nearest 0.5 mm.
Measured: 6-months post surgery
Secondary outcomes (10)
Complete Root Coverage (CRC)
Measured: 6 months post surgery
Percentage of Root Coverage (%)
Measured: 6 months post surgery
Keratinized Tissue Width (KTW)
Measured: 6 months post surgery
Recession Depth (RD)
Measured: 6 months post surgery
Recession Width (RW)
Measured: 6 months post surgery
Recession Reduction (Rec-Red)
Measured: 6 months post surgery
Clinical Attachment Level (CAL)
Measured: 6 months post surgery
Probing Depth (PD)
Measured: 6 months post surgery
Root Coverage Esthetic Score (RES)
Root coverage esthetic score (RES) will be measured through direct clinical inspection without magnification and will include five variables: gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), mucogingival junction alignment (MGJ), and gingival color (GC). Zero, 3, or 6 points were used for the evaluation of the position of the gingival margin, whereas a score of 0 or 1 point was used for each of the other variables.
Scoring System The maximum achievable esthetic score is 10 points. A score of 0 points is assigned if the final position of the gingival margin is equal to or apical to the initial recession depth, indicating failure of the root coverage procedure, regardless of the other parameters (color, scar formation, MTC, or MGJ). A score of 0 points is also assigned when partial or complete loss of the interproximal papilla (black triangle) occurs following treatment.
Measured: 6 months post surgery
Condition-specific Health-related Quality-of-life
Condition-specific health-related quality-of-life will be assumed to evaluate the patient satisfaction with the treatment outcome using a questionnaire based on a 5-point Likert scale, where patients will rate their level of satisfaction with the esthetic outcome and overall treatment result. The response options will range from 1 (very dissatisfied) to 5 (very satisfied). The questionnaire will be administered at the 6-month follow-up visit, and the mean satisfaction score will be calculated for each group for statistical comparison.
Measured: 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single RT1 Gingival Recession With no Loss of Interproximal AttachmentStudies of the same condition, open and under way.
- More trials run by Cairo 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tareq Mohammed Salah Ismail El Shamy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520539
- Sponsor's protocol ID
- role of hyaluronic acid
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gingival Thickness and Root Coverage Outcomes Following Coronally Advanced Flap Combined With Microneedling With or Without Cross-Linked Hyaluronic Acid in RT1 Recession Defects: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07520539
- Acronym / sponsor ID
- role of hyaluronic acid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Apr 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.
In patients with single RT1 recessions and thin gingival phenotype, does adding cross-linked hyaluronic acid by microneedling after CAF surgery produce greater gingival thickness gain and higher probability of complete root coverage at 6 months than microneedling alone?
Detailed description
The aim of this study is to evaluate changes in gingival thickness and root coverage outcomes after coronally advanced flap (CAF) then cross-linked hyaluronic acid injection along with performing microneedling in patients with RT1 single gingival recession with thin gingival phenotype in esthetic region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Combination Product: cross-linked hyaluronic acidMicroneedling sessions will be performed 1 month after the CAF procedure to ensure initial flap healing. The micro-needling technique will be performed under local anesthesia, by using Dr. Pen Ultima M8 MN pen (Dr. Pen; Phoenix, AZ, USA) using 16-Pins gauge with a diameter of 0.18 mm adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. The MN needles are vertically inserted into the keratinized tissue reaching the bone, for 30-40 s per tooth using an intermittent motion along the keratinized tissue. Then, cross-linked hyaluronic acid will be injected in a volume of 0.2mm of a 20 mg/ml concentration with particle size 400 μm. HA injection will be administrated until blanching of gingiva is evident. To ascertain that the HA is distributed evenly the region will be gently massaged for 2 to 3 min with a sterile gauze soaked in saline. This Microneedling technique with HA injection will be repeated four times at 10-day intervals. |
| control group | Active comparator | Device: MicroneedlingMicroneedling sessions will be performed 1 month after CAF procedure to ensure initial flap healing. The micro-needling technique will be performed under local anesthesia, by using Dr. Pen Ultima M8 MN pen (Dr. Pen; Phoenix, AZ, USA) using 16-Pins gauge with a diameter of 0.18 mm adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. The MN needles are vertically inserted into the keratinized tissue reaching the bone, for 30-40 s per tooth using an intermittent motion along the keratinized tissue. This method will be repeated four times at 10-day intervals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cross-linked hyaluronic acidMicroneedling sessions will be performed 1 month after the CAF procedure to ensure initial flap healing. The micro-needling technique will be performed under local anesthesia, by using Dr. Pen Ultima M8 MN pen (Dr. Pen; Phoenix, AZ, USA) using 16-Pins gauge with a diameter of 0.18 mm adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. The MN needles are vertically inserted into the keratinized tissue reaching the bone, for 30-40 s per tooth using an intermittent motion along the keratinized tissue. Then, cross-linked hyaluronic acid will be injected in a volume of 0.2mm of a 20 mg/ml concentration with particle size 400 μm. HA injection will be administrated until blanching of gingiva is evident. To ascertain that the HA is distributed evenly, the region will be gently massaged for 2 to 3 min with a sterile gauze soaked in saline. This Microneedling technique with HA injection will be repeated four times at 10-day intervals. | Combination product | test group |
| MicroneedlingMicroneedling sessions will be performed 1 month after CAF procedure to ensure initial flap healing. The micro-needling technique will be performed under local anesthesia, by using Dr. Pen Ultima M8 MN pen (Dr. Pen; Phoenix, AZ, USA) using 16-Pins gauge with a diameter of 0.18 mm adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. The MN needles are vertically inserted into the keratinized tissue reaching the bone, for 30-40 s per tooth using an intermittent motion along the keratinized tissue. This method will be repeated four times at 10-day intervals. | Device | control group |
Primary outcome
Gingival thickness
Time frame: 6-months post surgery
using a No.15 endodontic spreader with a silicon stopper placed 2 mm apical to the gingival margin at the mid-buccal aspect; depth of penetration measured with a ruler to the nearest 0.5 mm.
10 secondary outcomes
Complete Root Coverage (CRC)
Time frame: 6 months post surgery
Percentage of Root Coverage (%)
Time frame: 6 months post surgery
Keratinized Tissue Width (KTW)
Time frame: 6 months post surgery
Recession Depth (RD)
Time frame: 6 months post surgery
Recession Width (RW)
Time frame: 6 months post surgery
Recession Reduction (Rec-Red)
Time frame: 6 months post surgery
Clinical Attachment Level (CAL)
Time frame: 6 months post surgery
Probing Depth (PD)
Time frame: 6 months post surgery
Root Coverage Esthetic Score (RES)
Time frame: 6 months post surgery
Condition-specific Health-related Quality-of-life
Time frame: 6 months post surgery
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 15 Apr 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing cross-linked hyaluronic acid and Microneedling in people with Single RT1 Gingival Recession With no Loss of Interproximal Attachment, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Apr 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Gingival thickness (time frame: 6-months post surgery). 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 15 Apr 2026.