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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-20

Study Completion Date

2020-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Scaling and Root Planing (SRP)

Group Type ACTIVE_COMPARATOR

Scaling and Root Planing

Intervention Type PROCEDURE

Supra- and sub-gingival calculus and debris were removed

Scaling and Root Planing with Nitazoxanide hydrogel

Group Type EXPERIMENTAL

Nitazoxanide hydrogel

Intervention Type DRUG

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

Interventions

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Scaling and Root Planing

Supra- and sub-gingival calculus and debris were removed

Intervention Type PROCEDURE

Nitazoxanide hydrogel

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No