Application of Hyaluronic Acid in the Treatment of Periodontitis

Periodontal Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05073575
• Other study ID #: 235/21
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: Federico II University
• Contact: Luca Ramaglia
• Phone: +393476912911
• Email: luca.ramaglia[@]unina.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with periodontitis

• Age = 18 years old

• Single-rooted and multi-rooted teeth

• Presence of suprabony periodontal defects at a minimum of two adjacent teeth and a maximum of 7 adjacent teeth in either the maxilla or the mandible with a PD = 5 mm after completion of non-surgical periodontal treatment and re-evaluation

• Intrabony defect with an intraosseous component < 2 mm

Exclusion Criteria:

• Patients with systemic diseases

• Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to surgery

• Pregnant or lactating

• Tobacco smokers (= 10 cigarettes per day)

• Multi-rooted teeth with furcation involvement

• Increased tooth mobility (grade II and III)

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Periodontal Bone Loss

Intervention

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.
• 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

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Clinical Attachment Level (CAL) gain (millimeters)	Distance from the cementoenamel junction to the bottom of the pocket	baseline, 6 months after surgical periodontal therapy
Secondary	Change of Probing Depth (PD) (millimeters)	Distance from the gingival margin to the bottom of the pocket	baseline, 6 months after surgical periodontal therapy
Secondary	Change of Gingival Recession (GR) (millimeters)	Distance from gingival margin to the cementoenamel junction	baseline, 6 months after surgical periodontal therapy