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

NCT04768530 | Completed Phase 2

• 1 other identifier: Nitazoxanide & periodontitis
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Scaling and Root Planing (SRP)

ACTIVE COMPARATOR

Procedure: Scaling and Root Planing

Scaling and Root Planing with Nitazoxanide hydrogel

EXPERIMENTAL

Drug: Nitazoxanide hydrogel

Interventions

Scaling and Root Planing PROCEDURE

Supra- and sub-gingival calculus and debris were removed

Scaling and Root Planing (SRP)

Nitazoxanide hydrogel DRUG

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

Scaling and Root Planing with Nitazoxanide hydrogel

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maha Talaab: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Maha R. Taalab, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Sylvia Farid, BDS

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology department

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: February 24, 2021
• Study Start: July 20, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 30, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

EG (1)