Application of Hyaluronic Acid in the Treatment of Periodontitis

Sponsor

Federico II University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05073575

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Bone Loss	Procedure: Hyaluronic acid Procedure: No-hyaluronic acid	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study will be designed as a double-arm randomized controlled clinical trial. The suprabony defects of subjects allocated in HA group will be treated with open flap debridement and application of hyaluronic acid, while the suprabony defects of No-HA Group will be treated with open flap debridement alone. The null hypothesis of no statistically significant differences between the two modalities for the treatment of suprabony defects will be tested.The study will be designed as a double-arm randomized controlled clinical trial. The suprabony defects of subjects allocated in HA group will be treated with open flap debridement and application of hyaluronic acid, while the suprabony defects of No-HA Group will be treated with open flap debridement alone. The null hypothesis of no statistically significant differences between the two modalities for the treatment of suprabony defects will be tested.

Masking:

Single (Participant)

Masking Description:

Only patients will be unaware of the type of treatment performed, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hyaluronic acid Group Hyaluronic acid gel will be applied to exposed dental roots surfaces, after scaling and root planing therapy	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.
Active Comparator: No-hyaluronic acid Group Only scaling and root planning will be performed on the exposed dental roots surfaces	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

Arm

Intervention/Treatment

Experimental: Hyaluronic acid Group

Hyaluronic acid gel will be applied to exposed dental roots surfaces, after scaling and root planing therapy

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.

Active Comparator: No-hyaluronic acid Group

Only scaling and root planning will be performed on the exposed dental roots surfaces

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

Outcome Measures

Primary Outcome Measures

Change of Clinical Attachment Level (CAL) gain (millimeters) [baseline, 6 months after surgical periodontal therapy]
Distance from the cementoenamel junction to the bottom of the pocket

Secondary Outcome Measures

Change of Probing Depth (PD) (millimeters) [baseline, 6 months after surgical periodontal therapy]
Distance from the gingival margin to the bottom of the pocket
Change of Gingival Recession (GR) (millimeters) [baseline, 6 months after surgical periodontal therapy]
Distance from gingival margin to the cementoenamel junction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)