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the Effect of Sub-gingival Irrigation With Ibuprofen 2% Mouthwash in Treatment of Periodontal Diseases. (ibuprofen)

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ClinicalTrials.gov Identifier: NCT02538237
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Amirhossein Farahmand, Islamic Azad University, Tehran

Brief Summary:
Aim: Use an ibuprofen mouthwash 2% irrigate subgingival in improving the progression of periodontal diseases can be evaluated. Materials and Methods: 22 patients with chronic periodontitis without any systemic disease who have had periodontal disease, and 2 molars that have periodontal pockets deeper than 4 mm on either side of the lower jaw have the clinical examinations. Interventions: For patients who participated in this study, subjects who received oral hygiene instruction and scaling root planing (SRP), After 2 weeks, They were divided into two groups as determined by randomization in this study, Experimental group: ibuprofen 2% mouthwash (made from the Faculty of Pharmaceutical Sciences, Islamic Azad University, Tehran), Control group: placebo, Subgingival Irrigation of ibuprofen 2% mouthwash with an insulin syringe 0.5 ml were rinsed, Clinical measurements including probing depth (PD), clinical attachment levels (CAL), Plaque Index (PI), and Bleeding Index (BI) were recorded and the patients were recalled per once every 2 weeks for 3 months is repetitive, and at the end of 3 months, were evaluated changes in clinical periodontal parameters. ®

Condition or disease Intervention/treatment Phase
Periodontitis Drug: placebo Drug: Ibuprofen 2% mouthwash Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Split-mouth, Placebo-controlled, Clinical Trial of the Effect of Sub-gingival Irrigation With Ibuprofen Mouthwash in Treatment of Periodontal Diseases
Study Start Date : November 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ibuprofen mouthwash
Subgingival Irrigation of ibuprofen 2% mouthwash (made from the Faculty of Pharmaceutical Sciences, Islamic Azad University, Tehran) with an insulin syringe 0.5 ml were rinsed
Drug: Ibuprofen 2% mouthwash
Sham Comparator: placebo mouthwash
Subgingival Irrigation of placebo 2% mouthwash (made from the Faculty of Pharmaceutical Sciences, Islamic Azad University, Tehran) with an insulin syringe 0.5 ml were rinsed
Drug: placebo
the mouthwash(ibuprofen 2% or placebo) Subgingival Irrigation of mouthwash with an insulin syringe 0.5 ml were rinsed.
Other Name: Ibuprofen 2% mouthwash (made from the Faculty of Pharmaceutical Sciences, Islamic Azad University, Tehran)




Primary Outcome Measures :
  1. Reduction of periodontal pocket [ Time Frame: 15 days ]
    periodontal probe


Secondary Outcome Measures :
  1. Reduction of bleeding on probing [ Time Frame: 3 months ]
    periodontal probe



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The patients systemically healthy were selected for the study.
  • The subjects had with periodontal pocket depths of more than 4 mm on at least two teeth in the mandibular molar area that observed on probing.

Exclusion Criteria:

  • Existing systemic disease;
  • Hypersensitive to Ibuprofen;
  • The use of any Antibiotic or Anti-inflammatory drugs within the 6 months preceding the beginning of the study;
  • Cancer;
  • Pregnant or nursing females;
  • Smoking; Orthodontic treatments;
  • Extensive dental restorations;
  • Use removal denture;
  • Mouth rinses;
  • during the entire period of the study.

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Responsible Party: Amirhossein Farahmand, assistant prof, Islamic Azad University, Tehran
ClinicalTrials.gov Identifier: NCT02538237     History of Changes
Other Study ID Numbers: subgingival irrigation
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Ibuprofen
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action