A Phase 2 interventional study of Scaling and Root Planing and Nitazoxanide hydrogel in Periodontitis, sponsored by Maha Talaab. Completed at 1 site in Egypt. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-02-24.
Sponsored by Maha Talaab · Phase 2, Interventional, and Treatment
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.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 40 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →This is the only study on the registry with Maha Talaab as lead sponsor.
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Exclusion Criteria:
Procedure: Scaling and Root Planing
Drug: Nitazoxanide hydrogel
Supra- and sub-gingival calculus and debris were removed
Scaling and root planing was performed in combination with the subgingivally delivered thermosensitive Nitazoxanide hydrogel as adjunct antimicrobial therapy.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: up to 6 months
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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