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

Study Overview
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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.

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.

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

Conditions
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Periodontitis

Intervention / Treatment
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* Procedure: Scaling and Root Planing
* Drug: Nitazoxanide hydrogel


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Scaling and Root Planing (SRP)<br> | Procedure: Scaling and Root Planing<br>* Supra- and sub-gingival calculus and debris were removed<br>|
| Experimental: Scaling and Root Planing with Nitazoxanide hydrogel<br> | Drug: Nitazoxanide hydrogel<br>* Scaling and root planing was performed in combination with the subgingivally delivered thermosensitive Nitazoxanide hydrogel as adjunct antimicrobial therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |