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

Sponsor

Maha Talaab (Other)

Overall Status

Completed

CT.gov ID

NCT04768530

Collaborator

(none)

Enrollment

Location

Arms

9.4

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis	Procedure: Scaling and Root Planing Drug: Nitazoxanide hydrogel	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 20, 2019

Actual Primary Completion Date :

Apr 1, 2020

Actual Study Completion Date :

Apr 30, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.
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.
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.
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Alexandria University	Alexandria		Egypt	21527

Sponsors and Collaborators

Maha Talaab

Investigators

Study Chair: Maha R. Taalab, PhD, Faculty of Dentistry, Alexandria University, Egypt
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maha Talaab, Associate Professor, Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology department, Alexandria University

ClinicalTrials.gov Identifier:

NCT04768530

Other Study ID Numbers:

Nitazoxanide & periodontitis

First Posted:

Feb 24, 2021

Last Update Posted:

Feb 24, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Periodontitis

Nitazoxanide

Study Results

No Results Posted as of Feb 24, 2021