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

Phase 2

Completed

• Conditions: Periodontitis
• Interventions: Drug: Nitazoxanide hydrogel; Procedure: Scaling and Root Planing

• Registration Number: NCT04768530
• Lead Sponsor: Maha Talaab

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2019-07-20
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-30
• Status Verified: 2021-02
• Study First Submitted: 2021-02-21
• Study First Submitted QC: 2021-02-21
• Last Update Submitted: 2021-02-21
• Study First Posted: 2021-02-24
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Scaling and Root Planing with Nitazoxanide hydrogel	Nitazoxanide hydrogel	-
Scaling and Root Planing (SRP)	Scaling and Root Planing	-

Primary Outcome Measures

Name	Time	Method
Probing depth	up to 6 months	Probing depth was recorded at tested sites with graduated William's probe graduated in 1 mm increment. Readings were rounded to the nearest mm.
Bleeding on probing	up to 6 months	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.
Clinical attachment loss	up to 6 months	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.
Biochemical assessment of inflammation	up to 6 months	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.
Gingival index	up to 6 months	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

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt