An interventional study of Microneedling and cross-linked hyaluronic acid in Interdental Papilla Deficiency, sponsored by Badr University. Not yet recruiting. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Badr University · Not applicable, Interventional, and Treatment
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.
Badr University is the lead sponsor of 64 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Microneedling · Drug: cross-linked hyaluronic acid
Participants will receive submucosal injection of cross-linked hyaluronic acid without preceding microneedling. Three treatment sessions will be performed at 4-week intervals.
Drug: cross-linked hyaluronic acid
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 acid will be administered by submucosal injection into the interdental papilla. Three treatment sessions will be performed at 4-week intervals.
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.
Time frame: Baseline, 1 month, 3 months, and 6 months
Gingival Crevicular Fluid Periostin Level
Periostin concentration in gingival crevicular fluid will be measured using a commercially available human periostin ELISA kit.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Badr University