Interdental Papilla DeficiencyMN-iPRFNCT07907939
Microneedling-Assisted i-PRF for Interdental Papilla Deficiency
A study testing Autologous injectable platelet-rich fibrin (i-PRF) and Microneedling of the interdental papilla in people with Interdental Papilla Deficiency, run by Ehab Ayman Hussien Mohamed Abdelaal at 1 site in Egypt.
Trial summary
Loss of the gum tissue between teeth can leave visible gaps called black triangles. This study will compare injectable platelet-rich fibrin (i-PRF), prepared from the participant's own blood, with i-PRF combined with microneedling. Microneedling creates small controlled punctures in the gum tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interdental Papilla Deficiency
- What is being tested?
- Autologous injectable platelet-rich fibrin (i-PRF) and Microneedling of the interdental papilla
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2026to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- At least one interdental papilla defect classified as Nordland-Tarnow Class I or II.
- Distance between the contact point and interproximal bone crest of 7 mm or less.
- No open contact between the affected teeth.
- Completion of full-mouth periodontal treatment before enrollment.
- Willingness to participate and ability to provide written informed consent.
Who cannot join
- Systemic conditions affecting wound healing, soft tissue turnover, or immune response, including uncontrolled diabetes mellitus, immunosuppression, or coagulation disorders.
- Current use of anticoagulants, systemic corticosteroids, bisphosphonates, or medications known to affect gingival tissue or bone metabolism.
- Known hypersensitivity or allergy to hyaluronic acid or any component of the injectable preparation.
- Pregnancy or breastfeeding.
- Active periodontal disease.
- Smoking.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Periodontology Clinic, Dental Clinic Complex, Faculty of Oral and Dental Medicine, Badr University in Cairo
Badr, Cairo Governorate
Ehab Ayman Hussien Mohamed Abdelaal, BDS, +201500222777, contact@ehabayman.com
About this study
Official title: Effect of Microneedling-Assisted Injectable Platelet-Rich Fibrin (i-PRF) on Gingival Crevicular Fluid (GCF) Biomarkers and Clinical Papilla Outcomes in Interdental Papilla Deficiency: A Randomized Controlled Clinical Trial
Loss of the gum tissue between teeth can leave visible gaps called black triangles. This study will compare injectable platelet-rich fibrin (i-PRF), prepared from the participant's own blood, with i-PRF combined with microneedling. Microneedling creates small controlled punctures in the gum tissue. The aim is to assess whether combining these treatments improves the gum tissue between teeth more than i-PRF alone. Participants will receive three treatment sessions at four-week intervals and will be followed for six months. The study will measure black triangle height, periodontal health, patient satisfaction, and markers in fluid collected from around the gums.
Read the detailed description
This two-group clinical trial will be conducted at the Periodontology Clinic, Dental Clinic Complex, Faculty of Oral and Dental Medicine, Badr University in Cairo. The test group will receive microneedling of the deficient interdental papilla followed by injection of autologous injectable platelet-rich fibrin (i-PRF). The control group will receive i-PRF injection alone. Both groups will receive three treatment sessions at four-week intervals.
The i-PRF will be prepared from approximately 10 mL of venous blood collected in plastic tubes without anticoagulant and centrifuged using a horizontal centrifuge. The upper plasma layer will be aspirated and used immediately before fibrin polymerization. Local anesthesia with lidocaine and epinephrine will be administered by buccal infiltration adjacent to the papilla.
Clinical assessments will use a calibrated UNC-15 periodontal probe, with a standardized acrylic stent for black triangle height measurement. Gingival crevicular fluid will be collected with paper points for analysis of MMP-9, TIMP-1, and periostin using ELISA. The outcome assessor and laboratory analyst will be blinded to group allocation.
- Conditions
- Interdental Papilla Deficiency
- Being tested
- Autologous injectable platelet-rich fibrin (i-PRF), Microneedling of the interdental papilla
- Keywords
- Black triangles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous injectable platelet-rich fibrin (i-PRF)Biological
Approximately 10 mL of venous blood is collected in plastic tubes without anticoagulant and centrifuged using a horizontal centrifuge. The upper plasma layer is aspirated and used immediately within 3-5 minutes before fibrin polymerization. The i-PRF is injected submucosally into the deficient interdental papilla in three sessions at four-week intervals, with local anesthesia using lidocaine with epinephrine.
Microneedling of the interdental papillaProcedure or surgery
A sterile disposable microneedling device is applied to the deficient interdental papilla with controlled vertical and oblique strokes until uniform pinpoint bleeding is achieved. Gentle pressure is used for hemostasis before immediate i-PRF injection. Treatment is performed in three sessions at four-week intervals.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling plus injectable platelet-rich fibrin | Experimental | Microneedling of the deficient interdental papilla using a sterile disposable device with controlled vertical and oblique strokes until uniform pinpoint bleeding, followed by gentle pressure for hemostasis and immediate submucosal injection of autologous i-PRF. Three treatment sessions at four-week intervals, with local anesthesia using lidocaine with epinephrine. Receives: Biological: Autologous injectable platelet-rich fibrin (i-PRF); Procedure: Microneedling of the interdental papilla |
| Injectable platelet-rich fibrin alone | Active comparator | Submucosal injection of autologous injectable platelet-rich fibrin (i-PRF) into the deficient interdental papilla without prior microneedling. Three treatment sessions at four-week intervals, with local anesthesia using lidocaine with epinephrine. Receives: Biological: Autologous injectable platelet-rich fibrin (i-PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in black triangle height
Change in the height of the open gingival embrasure (black triangle), measured in millimeters using a calibrated UNC-15 periodontal probe with a standardized acrylic stent. A reduction in height indicates improvement.
Measured: Baseline, 1 month, 3 months, and 6 months following treatment
Secondary outcomes (7)
Change in Plaque Index
Plaque accumulation assessed using the Silness and Loe Plaque Index on a scale from 0 to 3. Higher scores indicate greater plaque accumulation.
Measured: Baseline, 1 month, 3 months, and 6 months following treatment
Change in Gingival Index
Gingival inflammation assessed using the Loe and Silness Gingival Index on a scale from 0 to 3. Higher scores indicate more severe gingival inflammation.
Measured: Baseline, 1 month, 3 months, and 6 months following treatment
Change in probing pocket depth
Probing pocket depth measured in millimeters using a UNC-15 periodontal probe to monitor periodontal conditions at the treated sites.
Measured: Baseline, 1 month, 3 months, and 6 months following treatment
Patient satisfaction with esthetic appearance
Patient satisfaction with esthetic appearance assessed using a visual analogue scale from 0 to 10, where 0 represents unsatisfied/worst imaginable appearance and 10 represents very satisfied/best imaginable appearance. Participants review pretreatment clinical photographs before completing the scale.
Measured: At the end of the 6-month follow-up
Change in gingival crevicular fluid MMP-9 levels
Matrix metalloproteinase-9 (MMP-9) concentration in gingival crevicular fluid, reported in ng/mL. Fluid is collected with paper points for 30 seconds and measured using a human MMP-9 ELISA kit in duplicate by a blinded laboratory analyst.
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months following treatment
Change in gingival crevicular fluid TIMP-1 levels
Tissue inhibitor of metalloproteinase-1 (TIMP-1) concentration in gingival crevicular fluid, reported in ng/mL. Fluid is collected with paper points for 30 seconds and measured using a human TIMP-1 ELISA kit in duplicate by a blinded laboratory analyst.
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months following treatment
Change in gingival crevicular fluid periostin levels
Periostin concentration in gingival crevicular fluid, reported in ng/mL. Fluid is collected with paper points for 30 seconds and measured using a human periostin ELISA kit in duplicate by a blinded laboratory analyst.
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interdental Papilla DeficiencyStudies 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
- Two parallel treatment groups with 1:1 allocation using a computer-generated random sequence and sealed opaque envelopes for allocation concealment. All interdental sites contributed by an individual participant receive the same assigned treatment. The planned sample comprises 20 interdental sites (10 per group); an individual participant may contribute more than one site.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ehab Ayman Hussien Mohamed Abdelaal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ehab Ayman Hussien Mohamed Abdelaal, Badr University
- Investigators
- Ehab Ayman Hussien Mohamed Abdelaal, BDS, Principal investigator, Faculty of Oral and Dental Medicine, Badr University in Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907939
- Sponsor's protocol ID
- BUC-IACUC-260517-169
- Acronym
- MN-iPRF
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Microneedling-Assisted Injectable Platelet-Rich Fibrin (i-PRF) on Gingival Crevicular Fluid (GCF) Biomarkers and Clinical Papilla Outcomes in Interdental Papilla Deficiency: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07907939
- Acronym / sponsor ID
- MN-iPRF / BUC-IACUC-260517-169
- Conditions
- Interdental Papilla Deficiency
- Keywords
- Black triangles
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ehab Ayman Hussien Mohamed AbdelaalUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Oct 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.
Loss of the gum tissue between teeth can leave visible gaps called black triangles. This study will compare injectable platelet-rich fibrin (i-PRF), prepared from the participant's own blood, with i-PRF combined with microneedling. Microneedling creates small controlled punctures in the gum tissue. The aim is to assess whether combining these treatments improves the gum tissue between teeth more than i-PRF alone. Participants will receive three treatment sessions at four-week intervals and will be followed for six months. The study will measure black triangle height, periodontal health, patient satisfaction, and markers in fluid collected from around the gums.
Detailed description
This two-group clinical trial will be conducted at the Periodontology Clinic, Dental Clinic Complex, Faculty of Oral and Dental Medicine, Badr University in Cairo. The test group will receive microneedling of the deficient interdental papilla followed by injection of autologous injectable platelet-rich fibrin (i-PRF). The control group will receive i-PRF injection alone. Both groups will receive three treatment sessions at four-week intervals.
The i-PRF will be prepared from approximately 10 mL of venous blood collected in plastic tubes without anticoagulant and centrifuged using a horizontal centrifuge. The upper plasma layer will be aspirated and used immediately before fibrin polymerization. Local anesthesia with lidocaine and epinephrine will be administered by buccal infiltration adjacent to the papilla.
Clinical assessments will use a calibrated UNC-15 periodontal probe, with a standardized acrylic stent for black triangle height measurement. Gingival crevicular fluid will be collected with paper points for analysis of MMP-9, TIMP-1, and periostin using ELISA. The outcome assessor and laboratory analyst will be blinded to group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel treatment groups with 1:1 allocation using a computer-generated random sequence and sealed opaque envelopes for allocation concealment. All interdental sites contributed by an individual participant receive the same assigned treatment. The planned sample comprises 20 interdental sites (10 per group); an individual participant may contribute more than one site.
| Arm | Type | Receives |
|---|---|---|
| Microneedling plus injectable platelet-rich fibrin | Experimental | Biological: Autologous injectable platelet-rich fibrin (i-PRF), Procedure: Microneedling of the interdental papillaMicroneedling of the deficient interdental papilla using a sterile disposable device with controlled vertical and oblique strokes until uniform pinpoint bleeding, followed by gentle pressure for hemostasis and immediate submucosal injection of autologous i-PRF. Three treatment sessions at four-week intervals, with local anesthesia using lidocaine with epinephrine. |
| Injectable platelet-rich fibrin alone | Active comparator | Biological: Autologous injectable platelet-rich fibrin (i-PRF)Submucosal injection of autologous injectable platelet-rich fibrin (i-PRF) into the deficient interdental papilla without prior microneedling. Three treatment sessions at four-week intervals, with local anesthesia using lidocaine with epinephrine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older.
- At least one interdental papilla defect classified as Nordland-Tarnow Class I or II.
- Distance between the contact point and interproximal bone crest of 7 mm or less.
- No open contact between the affected teeth.
- Completion of full-mouth periodontal treatment before enrollment.
Key exclusion criteria (6 listed)
- Systemic conditions affecting wound healing, soft tissue turnover, or immune response, including uncontrolled diabetes mellitus, immunosuppression, or coagulation disorders.
- Current use of anticoagulants, systemic corticosteroids, bisphosphonates, or medications known to affect gingival tissue or bone metabolism.
- Known hypersensitivity or allergy to hyaluronic acid or any component of the injectable preparation.
- Pregnancy or breastfeeding.
- Active periodontal disease.
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 |
|---|---|---|
| Autologous injectable platelet-rich fibrin (i-PRF)Approximately 10 mL of venous blood is collected in plastic tubes without anticoagulant and centrifuged using a horizontal centrifuge. The upper plasma layer is aspirated and used immediately within 3-5 minutes before fibrin polymerization. The i-PRF is injected submucosally into the deficient interdental papilla in three sessions at four-week intervals, with local anesthesia using lidocaine with epinephrine. | Biological | Injectable platelet-rich fibrin alone, Microneedling plus injectable platelet-rich fibrin |
| Microneedling of the interdental papillaA sterile disposable microneedling device is applied to the deficient interdental papilla with controlled vertical and oblique strokes until uniform pinpoint bleeding is achieved. Gentle pressure is used for hemostasis before immediate i-PRF injection. Treatment is performed in three sessions at four-week intervals. | Procedure or surgery | Microneedling plus injectable platelet-rich fibrin |
Primary outcome
Change in black triangle height
Time frame: Baseline, 1 month, 3 months, and 6 months following treatment
Change in the height of the open gingival embrasure (black triangle), measured in millimeters using a calibrated UNC-15 periodontal probe with a standardized acrylic stent. A reduction in height indicates improvement.
7 secondary outcomes
Change in Plaque Index
Time frame: Baseline, 1 month, 3 months, and 6 months following treatment
Change in Gingival Index
Time frame: Baseline, 1 month, 3 months, and 6 months following treatment
Change in probing pocket depth
Time frame: Baseline, 1 month, 3 months, and 6 months following treatment
Patient satisfaction with esthetic appearance
Time frame: At the end of the 6-month follow-up
Change in gingival crevicular fluid MMP-9 levels
Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months following treatment
Change in gingival crevicular fluid TIMP-1 levels
Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months following treatment
Change in gingival crevicular fluid periostin levels
Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months following treatment
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 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Interdental Papilla Deficiency
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Comparative Evaluation of Alb PRF Versus Connective Tissue Graft in Reconstruction of Deficient Interdental Papilla
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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.
Ehab Ayman Hussien Mohamed Abdelaal, BDS principal investigator
Faculty of Oral and Dental Medicine, Badr University in Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous injectable platelet-rich fibrin (i-PRF) and Microneedling of the interdental papilla in people with Interdental Papilla Deficiency, run by Ehab Ayman Hussien Mohamed Abdelaal at 1 site in Egypt.
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 6 inclusion and 6 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 30 Oct 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 Egypt. 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 Ehab Ayman Hussien Mohamed Abdelaal, BDS (+201500222777, contact@ehabayman.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in black triangle height (time frame: Baseline, 1 month, 3 months, and 6 months following treatment). 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 30 Oct 2026.