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Application and histologic evaluation of hyaluronic acid in the treatment of gingival papilla loss

Histologic evaluation of early papilla healing after augmentation with injectable hyaluronic acid. A proof of concept

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12070271
Enrollment
10
Registered
2024-04-25
Start date
2024-01-27
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of gingival papilla loss for patients diagnosed with periodontal disease Oral Health

Interventions

After steps 1 and 2 of periodontal treatment the selected patients will receive the papilla augmentation procedure. The suitable papillae will be injected once with approximately 0.2 ml of hyaluronic

Sponsors

Victor Babe? University of Medicine and Pharmacy Timi?oara
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Nonsmoking, aged above 18 years 2. Presence of an uninterrupted frontal arch (maxillary or mandibular) of teeth affected by severe periodontitis 3. Presence of interproximal pockets deeper than 6 mm in at least 6 adjacent teeth 4. Class I, II, or III papillary recession, according to Nordland and Tarnow's classification (1998) 5. The distance from the contact point to the alveolar bone crest =5 mm 6. Keratinized tissue width of the entire area to be operated of at least 3 mm 7. Good oral hygiene - Plaque Index (PlI<1)

Exclusion criteria

Exclusion criteria: 1. Systemic diseases such as diabetes mellitus, hypertension, or conditions that alter the outcome of periodontal therapy 2. Pregnant or lactating women 3. Tobacco users 4. Patients with known allergies to hyaluronic acid or any excipients of the product used 5. Patients with current or previous drug intake that may predispose to gingival enlargement 6. Patients under orthodontic treatment or having orthodontic treatment in the past 6 months 7. Patients with a history of traumatic oral hygiene measures or periodontal surgeries over the last 6 months in the area of interest

Design outcomes

Primary

MeasureTime frame
The presence of new collagen formation and the presence of the hyaluronic acid compound detected using histological analysis after hematoxylin-eosin staining, at 1 week, 2 weeks, and 3 weeks post hyaluronic acid injection recorded dichotomously on the specimens as the presence or absence of the parameter with the following scores: 0/- (absence), 1/+ (presence low), 2/++ (presence medium), 3/+++ (presence high)

Secondary

MeasureTime frame
The presence and characteristics of inflammatory infiltrate, detection of granulomatous reactions, presence of interstitial edema, detected at 1 week, 2 weeks and 3 weeks after hyaluronic injection recorded dichotomously on the specimens as the presence or absence of the parameter with the following scores: 0/- (absence), 1/+ (presence low), 2/++ (presence medium), 3/+++ (presence high)

Countries

Romania

Contacts

Public ContactOctavia-Carolina Vela
vela.octavia@umft.ro+40 (0)741706965

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026