Interdental Papilla DeficiencyNCT07919808
Microneedling-Assisted Hyaluronic Acid for Interdental Papilla Deficiency
A study testing Microneedling and cross-linked hyaluronic acid in people with Interdental Papilla Deficiency, run by Badr University.
Trial summary
This randomized controlled clinical trial will evaluate whether microneedling combined with cross-linked hyaluronic acid injection provides superior reconstruction of interdental papilla deficiency compared with hyaluronic acid injection alone. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Interdental Papilla Deficiency
- What is being tested?
- Microneedling and cross-linked hyaluronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to May 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Young adult patients aged .
- Presence of at least one interdental papilla defect classified as Nordland-Tarnow Class I or II.
- Distance between the contact point and the interproximal bone crest ≤7 mm.
- No open contact between the affected teeth.
- Full-mouth periodontal treatment completed prior to 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.
- Nordland-Tarnow Class III papilla loss at the study site.
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- Previous soft tissue augmentation procedures, surgical or injectable, at the study site.
- Use of any local or systemic anti-inflammatory medication within 3 months before enrollment.
- Smokers.
- Presence of restorations, crowns, veneers, or orthodontic brackets at or adjacent to the study site.
About this study
Official title: Microneedling-Assisted Hyaluronic Acid for Interdental Papilla Deficiency: Effects on Gingival Crevicular Fluid Biomarkers and Clinical Outcomes-A Randomized Controlled Clinical Trial
This randomized controlled clinical trial will evaluate whether microneedling combined with cross-linked hyaluronic acid injection provides superior reconstruction of interdental papilla deficiency compared with hyaluronic acid injection alone. Twenty participants with Nordland-Tarnow Class I or II interdental papilla deficiency will be randomly allocated into two parallel groups. The test group will receive microneedling followed by submucosal injection of cross-linked hyaluronic acid, while the control group will receive cross-linked hyaluronic acid injection alone. Three treatment sessions will be performed at 4-week intervals. Participants will be followed for 6 months. The primary outcome will be change in black triangle height. Secondary outcomes will include gingival crevicular fluid levels of MMP-9, TIMP-1 and periostin, plaque index, gingival index, periodontal probing depth, and patient satisfaction.
- Conditions
- Interdental Papilla Deficiency
- Being tested
- Microneedling, cross-linked hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroneedlingOther
A sterile disposable microneedling device will be applied to the interdental papilla using controlled vertical and oblique strokes until uniform punctate bleeding is observed.
cross-linked hyaluronic acidDrug
Cross-linked hyaluronic acid will be administered by submucosal injection into the interdental papilla. Three treatment sessions will be performed at 4-week intervals.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling + Hyaluronic Acid (MN+HA) | Experimental | Participants will receive microneedling of the interdental papilla followed by submucosal injection of cross-linked hyaluronic acid. Three treatment sessions will be performed at 4-week intervals. Receives: Other: Microneedling; Drug: cross-linked hyaluronic acid |
| Hyaluronic Acid (HA) | Active comparator | Participants will receive submucosal injection of cross-linked hyaluronic acid without preceding microneedling. Three treatment sessions will be performed at 4-week intervals. Receives: Drug: cross-linked hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Black Triangle Height
Black triangle height will be measured in millimeters as the linear distance from the base of the interproximal contact point to the most coronal tip of the interdental papilla using a calibrated UNC-15 periodontal probe. Standardized acrylic stents will be used to ensure reproducible probe angulation and reference point positioning.
Measured: Baseline, 1 month, 3 months, and 6 months
Secondary outcomes (7)
Gingival Crevicular Fluid Periostin Level
Periostin concentration in gingival crevicular fluid will be measured using a commercially available human periostin ELISA kit.
Measured: Baseline, 1 month, 3 months, and 6 months
Gingival Crevicular Fluid MMP-9 Level
MMP-9 concentration in gingival crevicular fluid will be measured using a commercially available human MMP-9 ELISA kit.
Measured: Baseline, 1 month, 3 months, and 6 months
Gingival Crevicular Fluid TIMP-1 Level
TIMP-1 concentration in gingival crevicular fluid will be measured using a commercially available human TIMP-1 ELISA kit.
Measured: Baseline, 1 month, 3 months, and 6 months
Plaque Index
Plaque accumulation will be assessed using the Silness and Löe Plaque Index on a score from 0 to 3.
Measured: Baseline, 1 month, 3 months, and 6 months
Gingival Index
Gingival inflammation will be assessed using the Löe and Silness Gingival Index on a score from 0 to 3.
Measured: Baseline, 1 month, 3 months, and 6 months
Periodontal Probing Depth
Periodontal probing depth will be measured in millimeters from the gingival margin to the base of the sulcus or periodontal pocket using a UNC-15 periodontal probe.
Measured: Baseline, 1 month, 3 months, and 6 months
Patient Satisfaction
Patient satisfaction with esthetic appearance will be assessed using a visual analogue scale at the end of the follow-up period.
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 posted5 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 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
- Participants will be randomly assigned to one of two parallel treatment groups: microneedling combined with cross-linked hyaluronic acid injection or cross-linked hyaluronic acid injection alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Hussein, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919808
- Sponsor's protocol ID
- BUC-IACUC-260517-185
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling-Assisted Hyaluronic Acid for Interdental Papilla Deficiency: Effects on Gingival Crevicular Fluid Biomarkers and Clinical Outcomes-A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07919808
- Acronym / sponsor ID
- BUC-IACUC-260517-185
- Conditions
- Interdental Papilla Deficiency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 Nov 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 will evaluate whether microneedling combined with cross-linked hyaluronic acid injection provides superior reconstruction of interdental papilla deficiency compared with hyaluronic acid injection alone. Twenty participants with Nordland-Tarnow Class I or II interdental papilla deficiency will be randomly allocated into two parallel groups. The test group will receive microneedling followed by submucosal injection of cross-linked hyaluronic acid, while the control group will receive cross-linked hyaluronic acid injection alone. Three treatment sessions will be performed at 4-week intervals. Participants will be followed for 6 months. The primary outcome will be change in black triangle height. Secondary outcomes will include gingival crevicular fluid levels of MMP-9, TIMP-1 and periostin, plaque index, gingival index, periodontal probing depth, and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel treatment groups: microneedling combined with cross-linked hyaluronic acid injection or cross-linked hyaluronic acid injection alone.
| Arm | Type | Receives |
|---|---|---|
| Microneedling + Hyaluronic Acid (MN+HA) | Experimental | Other: Microneedling, Drug: cross-linked hyaluronic acidParticipants will receive microneedling of the interdental papilla followed by submucosal injection of cross-linked hyaluronic acid. Three treatment sessions will be performed at 4-week intervals. |
| Hyaluronic Acid (HA) | Active comparator | Drug: cross-linked hyaluronic acidParticipants will receive submucosal injection of cross-linked hyaluronic acid without preceding microneedling. Three treatment sessions will be performed at 4-week intervals. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Young adult patients aged .
- Presence of at least one interdental papilla defect classified as Nordland-Tarnow Class I or II.
- Distance between the contact point and the interproximal bone crest ≤7 mm.
- No open contact between the affected teeth.
- Full-mouth periodontal treatment completed prior to enrollment.
Key exclusion criteria (10 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 |
|---|---|---|
| MicroneedlingA sterile disposable microneedling device will be applied to the interdental papilla using controlled vertical and oblique strokes until uniform punctate bleeding is observed. | Other | Microneedling + Hyaluronic Acid (MN+HA) |
| cross-linked hyaluronic acidCross-linked hyaluronic acid will be administered by submucosal injection into the interdental papilla. Three treatment sessions will be performed at 4-week intervals. | Drug | Hyaluronic Acid (HA), Microneedling + Hyaluronic Acid (MN+HA) |
Primary outcome
Change in Black Triangle Height
Time frame: Baseline, 1 month, 3 months, and 6 months
Black triangle height will be measured in millimeters as the linear distance from the base of the interproximal contact point to the most coronal tip of the interdental papilla using a calibrated UNC-15 periodontal probe. Standardized acrylic stents will be used to ensure reproducible probe angulation and reference point positioning.
7 secondary outcomes
Gingival Crevicular Fluid Periostin Level
Time frame: Baseline, 1 month, 3 months, and 6 months
Gingival Crevicular Fluid MMP-9 Level
Time frame: Baseline, 1 month, 3 months, and 6 months
Gingival Crevicular Fluid TIMP-1 Level
Time frame: Baseline, 1 month, 3 months, and 6 months
Plaque Index
Time frame: Baseline, 1 month, 3 months, and 6 months
Gingival Index
Time frame: Baseline, 1 month, 3 months, and 6 months
Periodontal Probing Depth
Time frame: Baseline, 1 month, 3 months, and 6 months
Patient Satisfaction
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 6 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling and cross-linked hyaluronic acid in people with Interdental Papilla Deficiency, run by Badr 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 6 inclusion and 10 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 6 Nov 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.
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?
Change in Black Triangle Height (time frame: Baseline, 1 month, 3 months, and 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 6 Nov 2026.