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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04768530
• Other study ID #: Nitazoxanide & periodontitis
• Status: Completed
• Phase: Phase 2
• Start date: July 20, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: February 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Scaling and Root Planing
Supra- and sub-gingival calculus and debris were removed

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Maha Talaab

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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