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

Primary Purpose

Periodontitis

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Scaling and Root Planing

Nitazoxanide hydrogel

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Scaling and Root Planing (SRP)

Scaling and Root Planing with Nitazoxanide hydrogel

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

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.

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04768530

First Posted

February 21, 2021

Last Updated

February 21, 2021

Sponsor

Maha Talaab

1. Study Identification

Unique Protocol Identification Number

NCT04768530

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

July 20, 2019 (Actual)

Primary Completion Date

April 1, 2020 (Actual)

Study Completion Date

April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Maha Talaab

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Scaling and Root Planing (SRP)

Arm Type

Active Comparator

Arm Title

Scaling and Root Planing with Nitazoxanide hydrogel

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Scaling and Root Planing

Intervention Description

Supra- and sub-gingival calculus and debris were removed

Intervention Type

Drug

Intervention Name(s)

Nitazoxanide hydrogel

Intervention Description

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

Primary Outcome Measure Information:

Title

Probing depth

Description

Probing depth was recorded at tested sites with graduated William's probe graduated in 1 mm increment. Readings were rounded to the nearest mm.

Time Frame

up to 6 months

Title

Clinical attachment loss

Description

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.

Time Frame

up to 6 months

Title

Bleeding on probing

Description

Time Frame

up to 6 months

Title

Gingival index

Description

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

Time Frame

up to 6 months

Title

Biochemical assessment of inflammation

Description

Time Frame

up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: