PeriodontitisPhase 2NCT04768530
Nitazoxanide as a New Local Adjunctive to Nonsurgical Treatment of Moderate Periodontitis
A Phase 2 study testing Scaling and Root Planing and Nitazoxanide hydrogel in people with Periodontitis, run by Maha Talaab at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Scaling and Root Planing and Nitazoxanide hydrogel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2019to 30 Apr 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nitazoxanide as a New Local Adjunctive to Nonsurgical Treatment of Moderate Periodontitis: Clinical and Biochemical Evaluation
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.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- Scaling and Root Planing, Nitazoxanide hydrogel
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and Root PlaningProcedure or surgery
Supra- and sub-gingival calculus and debris were removed
Nitazoxanide hydrogelDrug
Scaling and root planing was performed in combination with the subgingivally delivered thermosensitive Nitazoxanide hydrogel as adjunct antimicrobial therapy.
| Study group | Role | What they receive |
|---|---|---|
| Scaling and Root Planing (SRP) | Active comparator | Not described Receives: Procedure: Scaling and Root Planing |
| Scaling and Root Planing with Nitazoxanide hydrogel | Experimental | Not described Receives: Drug: Nitazoxanide hydrogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start20 Jul 2019
- Primary completion1 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maha Talaab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maha Talaab, Alexandria University
- Investigators
- Maha R. Taalab, PhD, Study chair, Faculty of Dentistry, Alexandria University, EgyptSylvia Farid, BDS, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptShaimaa Maklad, PhD, Study director, Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, EgyptLabiba El-Khordagui, PhD, Study director, Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, EgyptMaha El Tantawi, PhD, Study director, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768530
- Sponsor's protocol ID
- Nitazoxanide & periodontitis
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitazoxanide as a New Local Adjunctive to Nonsurgical Treatment of Moderate Periodontitis: Clinical and Biochemical Evaluation
- ClinicalTrials.gov ID
- NCT04768530
- Acronym / sponsor ID
- Nitazoxanide & periodontitis
- Conditions
- Periodontitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Maha TalaabUniversity, hospital or other
- Study start
- 20 Jul 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scaling and Root Planing (SRP) | Active comparator | Procedure: Scaling and Root Planing |
| Scaling and Root Planing with Nitazoxanide hydrogel | Experimental | Drug: Nitazoxanide hydrogel |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaling and Root PlaningSupra- and sub-gingival calculus and debris were removed | Procedure or surgery | Scaling and Root Planing (SRP) |
| Nitazoxanide hydrogelScaling and root planing was performed in combination with the subgingivally delivered thermosensitive Nitazoxanide hydrogel as adjunct antimicrobial therapy. | Drug | Scaling and Root Planing with Nitazoxanide hydrogel |
Primary outcome
Probing depth
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maha R. Taalab, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
Sylvia Farid, BDS principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Shaimaa Maklad, PhD study director
Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Scaling and Root Planing and Nitazoxanide hydrogel in people with Periodontitis, run by Maha Talaab at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth (time frame: up to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.