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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scaling and Root Planing (SRP) | Active Comparator |
| |
| Scaling and Root Planing with Nitazoxanide hydrogel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaling and Root Planing | Procedure | Supra- and sub-gingival calculus and debris were removed |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maha R. Taalab, PhD | Faculty of Dentistry, Alexandria University, Egypt | Study Chair |
| Sylvia Farid, BDS | Faculty of Dentistry, Alexandria University, Egypt | Principal Investigator |
| Shaimaa Maklad, PhD | Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Egypt | Study Director |
| Labiba El-Khordagui, PhD | Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Egypt | Study Director |
| Maha El Tantawi, PhD | Faculty of Dentistry, Alexandria University, Egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Alexandria | 21527 | Egypt |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
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| Nitazoxanide hydrogel | Drug | Scaling and root planing was performed in combination with the subgingivally delivered thermosensitive Nitazoxanide hydrogel as adjunct antimicrobial therapy. |
|
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |