- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04125706
Locally Delivered Antibiotics for the Treatment of Periodontitis
Locally Delivered Antibiotics for the Treatment of Periodontitis Topical Doxycycline Versus Minocycline Gels as an Adjunct to Mechanical Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Forty-four patients in the age group of 25-50 years (males and females) who are suffering from periodontitis with almost similar probing depth bilaterally (≥ 6 mm) at the selected sites and exhibiting bleeding on probing.
A written informed consent will be taken from the patients prior to the study.
Each patient will be recalled 4 weeks after completion of both sides supra-gingival scaling, which formed the baseline visit. Plaque scores will be brought to zero, and the probing pocket depth and gingival index, will be recorded on the proforma specially prepared for the purpose.
The selected treatment sites will be then divided into two groups, and sub-gingival SRP will be performed prior to the delivery of the drugs at the test sites.
- Group I: Consist of periodontal pockets on the left side of maxillary or mandibular arch and received sub-gingival Minocycline 2% gel.
- Group II: Consist of periodontal pockets on the left side of maxillary or mandibular arch and received Metronidazole 0.75% gel.
The right side will be left as a control in both groups Patients will be recalled after 6 weeks from the baseline visit to record the plaque index, gingival index, bleeding index and probing depth (UNC probe 12 mm).
Statistical Analysis:
The unit of measurement in this study is the site, rather than the subject. Student-t test was To compare between Group 1 (Minocycline 2 %) and Group 2 (Metronidazole 0.75 %), Data will check for normality, if the data normally distributed Independent t-test will use to test if there any significant differences between groups, otherwise if not normally Mann -Whitney U-test (Non-parametric) will use to detects the difference.
To achieve 80% power of statistical test to detect the differences between Metronidazole and Minocycline With 5 % level of significant, 19.6 reduction in probing depth (previous study-vi) and standard deviation of 0.23, using the following formula.
n=(2σ^2 〖(Z_(β+Z_(1-α/2) ))〗^2)/d^2 22 per group (minimum sample size) where: σ =0.23 Zβ =0.84 Z(1-α/2) =1.96, d= 19.6%
For objective 2, the statistical test in case of normal data distribution will be paired t test or will use Willcoxon Sign Ranked test if it not normally distributed.
To achieve 80% power of statistical test to detect the differences between Metronidazole and Minocycline. With 5% level of significant.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sasha M Suliman, MSc
- Phone Number: 966533215808
- Email: sashasuliman@riyadh.edu.sa
Study Contact Backup
- Name: Omer AlKadhi
- Email: Omar.AlKadhi@riyadh.edu.sa
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients suffering from chronic periodontitis with almost similar probing depth bilaterally (≥
- 6 mm) at the selected sites and exhibiting bleeding on probing Patients with no caries and restorations on the selected teeth
- Patients showing effective individual oral hygiene.
Exclusion Criteria:
Patients presenting with history of intake of local and/or systemic antibiotic therapy for the last 3 months
- Patients with known systemic and debilitating diseases (Muscular Dystrophy)
- Patients presenting with known adverse reactions to any component of the test agent
- Patients on anticoagulant therapy
- Pregnant and lactating females
- Smokers
- Patients in a regular use of mouth wash
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mincycline hydrochloride 2% oral gel
Minocycline will be delivered locally in the periodontal pocket.
|
Minocycline will be delivered locally in the periodontal pocket
Other Names:
|
Experimental: Metronidazole hylcate 0.75 % oral gel
Metronidazole gel will be delivered locally in the periodontal pocket.
|
Metronidazole will be delivered locally in the periodontal pocket
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
plaque index
Time Frame: Baseline to six weeks
|
To measure the state of oral hygiene as: 0 = No plaque in the gingival area
The Plaque Index is the four gingival areas of the tooth (buccal, lingual/palatal, mesial, distal) given a score from 0-3 and scores were added and divided by four. The plaque index for the individual was obtained by adding the indices for the teeth and divide by the number of teeth examined. |
Baseline to six weeks
|
gingival index
Time Frame: Baseline to six weeks
|
To assess the gingival condition and record qualitative chances in the gingiva as: 0 = Normal gingiva
The bleeding will be assessed by gently probing along the wall of the soft tissue of the gingival sulcus. To get the gingival index for the tooth, the four areas of the tooth (buccal, lingual/palatal, mesial, distal) are scored by the sum and divided by four. The gingival index for the individual will be obtained by adding the indices of the teeth and divided by the number of teeth examined. |
Baseline to six weeks
|
probing depth
Time Frame: Baseline to six weeks
|
The distance from the gingival margin to base of the sulcus.
Will be measured at six sites per tooth (mesio-buccal, buccal, disto-buccal, disto-lingual, lingual and mesio-lingual) at all teeth with UNC-15 probe.
|
Baseline to six weeks
|
IL6
Time Frame: Baseline to six weeks
|
In healthy subjects it ranges from 0.5-5 pg/ml In eosinophilic subjects it ranges from 3-18pg/ml in plasma
|
Baseline to six weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sasha M Suliman, MSc, Ar Riyad, Saudi Arabia, 11681
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FRP/2019/53
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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