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Completed

NCT Number: NCT04768530

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scaling and Root Planing

Procedure

Supra- and sub-gingival calculus and debris were removed

Nitazoxanide hydrogel

Drug

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

Primary outcomes

  1. Probing depth

    Time frame: 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.

  2. Clinical attachment loss

    Time frame: 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.

  3. Bleeding on probing

    Time frame: 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.

  4. Gingival index

    Time frame: 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

  5. Biochemical assessment of inflammation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Maha Talaab

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 24, 2021
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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