Nitazoxanide as a New Local Adjunctive to Nonsurgical Treatment of Moderate Periodontitis

Maha Talaab40 enrolled

Overview

The aim of the study was to assess the effect of nitazoxanide delivered subgingivally as thermosensitive hydrogel on the clinical and biochemical outcomes of SRP in patients with moderate periodontitis.

A randomized, controlled clinical trial in a split-mouth design was conducted on forty patients equally divided between two groups: a control group treated with full mouth scaling and root planing (SRP) and a test group treated with SRP combined with subgingivally delivered 0.01% NTZ sustained release Poloxamer 407/hyaluronic acid thermosensitive hydrogel.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Periodontitis

Interventions

Scaling and Root PlaningPROCEDURE

Supra- and sub-gingival calculus and debris were removed

Nitazoxanide hydrogelDRUG

Scaling and root planing was performed in combination with the subgingivally delivered thermosensitive Nitazoxanide hydrogel as adjunct antimicrobial therapy.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients having probing depth (PD) ≥5 mm. * Patients having bleeding on probing (BOP) in proximal tooth surface. * Patients who could maintain an O'Leary plaque index ≤10 proceeded into the study. Exclusion Criteria: * Patients having any systemic disease that may affect the treatment outcomes. * Smokers. * Pregnant females. * Patients receiving contraindicated medications, chemotherapy, or radiotherapy in the previous year.

Locations (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

Probing depth

Probing depth was recorded at tested sites with graduated William's probe graduated in 1 mm increment. Readings were rounded to the nearest mm.

Time frame: up to 6 months

Clinical attachment loss

Clinical attachment loss was recorded at tested sites with graduated William's probe graduated in 1 mm increment. Readings were rounded to the nearest mm.

Time frame: up to 6 months

Bleeding on probing

Bleeding on probing was assessed at tested sites with graduated William's probe graduated in 1 mm increment, within 15 seconds after probing, using a dichotomous scoring system (+ and -) for presence or absence, respectively.

Time frame: up to 6 months

Gingival index

Gingival index was assessed at 4 sites on six index teeth. Scores range from 0 to 3, with 0 being normal and 3 being severe inflammation

Time frame: up to 6 months

Biochemical assessment of inflammation

This involved determination of the gingival crevicular fluid (GCF) levels of matrix metalloproteinase 8 (MPP-8). A GCF sample was taken from the area showing the deepest pocket depth around the treated area.The samples were diluted in phosphate buffer saline (PBS) up to 1 mL. After waiting for 15 min, the paper points were removed, and 500 μL were centrifuged at 400 g for 4 min, then frozen at -20°C pending MMP-8 analysis using Human Matrix metalloproteinase 8/Neutrophil collagenase (MMP-8) ELISA Kit according to the manufacturer instructions.

Time frame: up to 6 months

Data from ClinicalTrials.gov

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