Microneedling-Assisted Hyaluronic Acid for Interdental Papilla Deficiency
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Microneedling + Hyaluronic Acid (MN+HA)
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. |
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. |
|
Aktiver Komparator: Hyaluronic Acid (HA)
Participants will receive submucosal injection of cross-linked hyaluronic acid without preceding microneedling. Three treatment sessions will be performed at 4-week intervals. |
Cross-linked hyaluronic acid will be administered by submucosal injection into the interdental papilla. Three treatment sessions will be performed at 4-week intervals. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Black Triangle Height
Zeitfenster: 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. |
Baseline, 1 month, 3 months, and 6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Gingival Crevicular Fluid Periostin Level
Zeitfenster: Baseline, 1 month, 3 months, and 6 months
|
Periostin concentration in gingival crevicular fluid will be measured using a commercially available human periostin ELISA kit. |
Baseline, 1 month, 3 months, and 6 months
|
|
Gingival Crevicular Fluid MMP-9 Level
Zeitfenster: Baseline, 1 month, 3 months, and 6 months
|
MMP-9 concentration in gingival crevicular fluid will be measured using a commercially available human MMP-9 ELISA kit. |
Baseline, 1 month, 3 months, and 6 months
|
|
Gingival Crevicular Fluid TIMP-1 Level
Zeitfenster: Baseline, 1 month, 3 months, and 6 months
|
TIMP-1 concentration in gingival crevicular fluid will be measured using a commercially available human TIMP-1 ELISA kit. |
Baseline, 1 month, 3 months, and 6 months
|
|
Plaque Index
Zeitfenster: Baseline, 1 month, 3 months, and 6 months
|
Plaque accumulation will be assessed using the Silness and Löe Plaque Index on a score from 0 to 3. |
Baseline, 1 month, 3 months, and 6 months
|
|
Gingival Index
Zeitfenster: Baseline, 1 month, 3 months, and 6 months
|
Gingival inflammation will be assessed using the Löe and Silness Gingival Index on a score from 0 to 3. |
Baseline, 1 month, 3 months, and 6 months
|
|
Periodontal Probing Depth
Zeitfenster: Baseline, 1 month, 3 months, and 6 months
|
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. |
Baseline, 1 month, 3 months, and 6 months
|
|
Patient Satisfaction
Zeitfenster: 6 months
|
Patient satisfaction with esthetic appearance will be assessed using a visual analogue scale at the end of the follow-up period. |
6 months
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BUC-IACUC-260517-185
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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