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

Nitazoxanide as a New Local Adjunctive to Nonsurgical Treatment of Moderate Periodontitis: Clinical and Biochemical Evaluation

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Scaling and Root Planing; Drug: Nitazoxanide hydrogel

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21527
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Scaling and Root Planing (SRP)	Procedure: Scaling and Root Planing; Supra- and sub-gingival calculus and debris were removed
EXPERIMENTAL: Scaling and Root Planing with Nitazoxanide hydrogel	Drug: Nitazoxanide hydrogel; Scaling and root planing was performed in combination with the subgingivally delivered thermosensitive Nitazoxanide hydrogel as adjunct antimicrobial therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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.	up to 6 months

Collaborators and Investigators

• Sponsor: Maha Talaab
• Investigators: Principal Investigator: Sylvia Farid, BDS, Faculty of Dentistry, Alexandria University, Egypt; Study Director: Shaimaa Maklad, PhD, Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Egypt; Study Director: Labiba El-Khordagui, PhD, Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Egypt; Study Director: Maha El Tantawi, PhD, Faculty of Dentistry, Alexandria University, Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2019
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): April 30, 2020

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: February 21, 2021
• First Posted (ACTUAL): February 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 21, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Anti-Infective Agents; Antiparasitic Agents; Nitazoxanide
• Other Study ID Numbers: Nitazoxanide & periodontitis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No