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Efficacy of a Gel Containing Polynucleotides and Hyaluronic Acid in Supraosseous Periodontal Defects Treated with the Single Flap Approach

NCT06897085 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-04-01

No results posted yet for this study

Summary

Treatment of supraosseous defects (SD) may be challenging due to their limited regenerative potential. When located in aesthetic areas, treatment may result in a gingival recession increase with consequent patients' concerns in terms of aesthetic or tooth sensibility. In the present study, a minimally-invasive surgical procedure (namely, the Single Flap Approach, SFA) will be combined with the application of a viscoelastic gel containing polynucleotides and hyaluronic acid that was reported to positively modulate periodontal wound healing. The outcomes, evaluated 6 months after treatment, will be compared to those obtained with SFA alone. The evaluated outcomes will be either clinical (evaluation of clinical parameters such as gingival recession, residual probing depth, clinical attachment gain) or related to patient's perception (such as evaluation of the aesthetic or tooth sensibility).

Conditions

  • Periodontitis
  • Gingival Recession, Localized
  • Aesthetic Perception
  • Aesthetic Outcomes

Interventions

DEVICE

viscoelastic gel containing polynucleotides and hyaluronic acid

Defects randomized to "test treatment" will receive a viscoelastic gel containing polynucleotides and hyaluronic acid (PN-HA gel) immediately at the completion of intra-surgical instrumentation. PN-HA gel will be also applied on the surgical wound at the completion of the suturing phase.

OTHER

No intervention

Defects randomized to "control group" will be accessed with the SFA and no PN-HA gel will be applied.

Sponsors & Collaborators

  • Azienda Unità Sanitaria Locale (A.U.S.L.) Ferrara, Italy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-12-30
Completion
2026-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06897085 on ClinicalTrials.gov