Periodontitis
Conditions
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.
Interventions
PROCEDUREScaling and Root Planing
Supra- and sub-gingival calculus and debris were removed
DRUGNitazoxanide hydrogel
Scaling and root planing was performed in combination with the subgingivally delivered thermosensitive Nitazoxanide hydrogel as adjunct antimicrobial therapy.
Sponsors
Maha Talaab
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth | up to 6 months | 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 | up to 6 months | 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 | up to 6 months | 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 | up to 6 months | 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 | up to 6 months | 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. |
Countries
Egypt
Outcome results
None listed