NCT05073575

Application of Hyaluronic Acid in the Treatment of Periodontitis

Healing of Periodontal Suprabony Defects Following Treatment With Open Flap Debridement With or Without Hyaluronic Acid (HA) Application

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The aim of the present investigation will be evaluated the healing of suprabony defects following surgical flap elevation and hyaluronic acid application respect to surgical flap elevation alone. A total of 80 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: hyaluronic acid group and no-hyaluronic acid group.

Detailed description

The objective of the study will be compare the healing of suprabony defects following treatment with either open flap debridement (OFD) and application of hyaluronic acid (HA) with OFD alone. Eighty patients with suprabony periodontal defects will be randomly assigned to treatment with open flap debridement and application of hyaluronic acid (HA Group) or open flap debridement alone (No-HA Group). Primary outcome will be Clinical Attachment Level (CAL) gain, while the secondary outcomes will be Probing Depth (PD) and Gingival Recession (GR). After local anesthesia, an access flap will be prepared. Depending on the mesiodistal width of the interproximal space, two different incision techniques will be selected to access the suprabony defect area. The modified papilla preservation technique (MMPT) will be used at sites with an interproximal width \> 2 mm, whereas the simplified papilla preservation technique (SPPT) will be applied at sites with an interproximal width ≤ 2 mm. Then, a mucoperiosteal flap will be reflected. Scaling and root planning will be performed combining the use of metal curettes and power-driven instrumentation by means of ultrasonic scaler. Hyaluronic acid will be applied to exposed roots surface only in HA Group followed, for both groups, by a tension-free primary closure of the interdental papillae and of the mucoperiostal flaps by means of 5-0 monofilament (polypropylene) non-resorbable suturing material.

Conditions

• Periodontal Bone Loss

Interventions

Type	Name	Description
PROCEDURE	Hyaluronic acid	After local anesthesia, an access flap will be prepared. Scaling and root planning will be performed combining the use of metal curettes and power-driven instrumentation by means of ultrasonic scaler. Hyaluronic acid gel will be applied to exposed roots surface, followed by a tension-free primary closure of the surgery wound by means of 5-0 monofilament (polypropylene) non-resorbable suturing material.
PROCEDURE	No-hyaluronic acid	An access flap will be prepared in order to perform scaling and root planning therapy with the use of metal curettes. After intervention, a tension-free primary closure of the interdental papillae and of the mucoperiosteal flaps by means of 5-0 monofilament (polypropylene) non-resorbable suturing materia will be performed

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-07-01
• Completion: 2024-10-01
• First posted: 2021-10-11
• Last updated: 2024-02-28

Locations

1 site across 1 country: Italy