- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02538224
Efficacy of Subgingivally Delivered Doxycycline Plus Ketoprofen Gel as an Adjunct to Non-surgical Periodontal Treatment
Randomized, Double Blind, Placebo Controlled Clinical Trial of Compare With Doxycycline Plus Ketoprofen Gel in Chronic Periodontitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Source of Data In this 8 month follow up, longitudinal intervention study, a total of 20patients (9 males and 11 females, Age range: 30-50 years) with chronic periodontitis were selected from the outpatient section of the Department of Periodontics, Islamic Azad University Dental School of Tehran /Iran. The study met the criteria of the Helsinki Declaration of1975, revised in 2008. The survey plan was reviewed and sanctioned, approved by the ethics commission of the Institutional Ethical Committee and Review Board of the Deputy of Research, School of Dentistry. All subjects received oral and written explanation of the intent of the survey and signed an informed consent after receiving detailed information about the purpose, the benefits, and the possible risks associated with the trial. The study was conducted from October 2012 to November 2013. The study was registered at the Iranian registry of clinical trials (IRCT), registration code: IRCT2014050717587N2.
Selection Criteria Patients meeting all of the following criteria were included in the study: aged between 30 and 45 years; 20 natural teeth present; clinical and radiographic signs of moderate (clinical attachment level of 2 to 3mm); probing depth (PD) of >4 mm; no periodontal treatment the previous 6 months; and willingness to comply with the study protocol.
Patients were excluded from the study if they met one or more of the following criteria: 1) existing systemic disease that may influence the severity or progression of periodontitis; taking medications that may influence the periodontium (e.g., non-steroidal anti-inflammatory drugs) or other medicines (antibiotic) within the 6 months preceding the beginning of the study; concurrent or planned orthodontic treatments; planned extensive dental restorations; patients with cavitated caries; pregnancy or lactation; mouth rinses during the entire period of the study; hypersensitive to doxycycline or ketoprofen; smoking.
Grouping Criteria Patients received scaling and root planing on first visit in accordance with the one stage full-mouth debridement protocol + polishing; the therapeutic endpoint was defined as a clean root surface void of visible or clinically detectable remnants of biofilm or calculus. After 2 weeks (debridement), was applied into all periodontal pockets with PD of ≥4 mm using a syringe with a blunt canula. The canula was inserted to the base of the periodontal pocket and gel was applied 0/5 ml on each side of the mandible. After patient enrollment by an examiner; using blocked randomization with a block size of 4 and an allocation ratio of 1:1 Block randomization was chosen to prevent too much variability in the number of patients randomized and ensure a reasonably steady flow of patients to each treatment group, Allocation cover was ensured by using container and labeling that did not reveal the content of the trial drug packages who was blind to the therapist and the clinical examination. Patients were randomly assigned to either the A or B group, while mandibular arches are each divided into two parts (left and right sections) with 100 sites in both groups.
In the A group, was treated by scaling and root planing (SRP) followed by local delivery of doxycycline 3%+ ketoprofen 2.5%, while the B group was treated by scaling and root planing along with ketoprofen 2.5%; and was administered to the both groups every 15 days for 3 months. After treatment, patients were given thorough oral hygiene instructions, the trial gel for local application contained ketoprofen gel (2.5% Sanofi Pharmaceutical plant construction in France) + 3 % doxycycline (Kharazmi Pharmaceutical manufacture in Iran) in the group (A), another group (B) ketoprofen 2.5%gel was used. After treatment, patients were given thorough oral hygiene instructions and were asked to use dentifrice sodium fluorides (Crest cavity protection) and to finish from using any mouthwashes during the course of the study. The subjects were given careful instructions in self-performed plaque-control measures: twice-daily tooth brushing using the Bass brushing technique with a soft toothbrush and a regular fluoride containing toothpaste and once-daily Interdental cleaning using dental floss. Clinical parameters, including Plaque Index (PI) (18), sulcus bleeding index (19). Probing depth (PD) and clinical attachment level (CAL) were recorded at baseline (before the SRP) and at 0, 15,30,45,60 days and 3 months. William's periodontal probe was used to standardize the measurement of clinical parameters. All pre- and post-treatment clinical parameters were recorded by an examiner who was masked to the type of treatment received by the patients while another clinician provided treatment for both groups. All pre- and post-treatment clinical parameters were recorded by an examiner who was masked to the type of treatment received by the patients while another clinician provided treatment for both groups.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adult patients,
- older than 18 years old,
- systemically healthy, and
- having at least 20 teeth.
Exclusion Criteria:
- patients with cavitated caries,
- no periodontal pockets larger than 4 mm,
- orthodontic appliances or removable prostheses,
- allergies to cetylpyridinium or CHX,
- use of antibiotics and anti-inflammatory drugs in the past 3 months that might alter normal gingival health,
- oral prophylaxis outside of study;
- use of oral chlorhexidine products or participation in an oral rinse study within 3 months prior to baseline examination,
- pregnancy or lactation,
- smoking.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: experimental(case): group A
Group A: 2.5%ketoprofen gel + 3 % doxycycline gel which(0.05cc,mixed
gel) be put into the periodontal pocket using an insulin syringe;For every 15 days within 3 months .
|
GroupA:(0.05cc, mixed gel) be put into the periodontal pocket using an insulin syringe. Intervention category Treatment: drugs
Other Names:
GroupB:2.5%ketoprofen
gel which be inserted into the periodontal pocket using an insulin syringe .
Other Names:
|
SHAM_COMPARATOR: control: group B
Group B: 2.5%ketoprofen gel which (0.05cc,gel)be put into the periodontal pocket using an insulin syringe;For every 15 days within 3 months .
|
GroupB:2.5%ketoprofen
gel which be inserted into the periodontal pocket using an insulin syringe .
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of pocket depth
Time Frame: 15 days
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of bleeding on probing
Time Frame: 15 days
|
15 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: amirhossein farahmand, assoc prof, azad tehran
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Periodontal Diseases
- Mouth Diseases
- Periodontitis
- Chronic Periodontitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Doxycycline
- Ketoprofen
Other Study ID Numbers
- azadtehran
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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