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

NCT02538237 | Completed Phase 2 DMC

• 1 other identifier: subgingival irrigation
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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. ®

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Reduction of periodontal pocket

  periodontal probe

  15 days

Secondary Outcomes (1)

• Reduction of bleeding on probing

  3 months

Study Arms (2)

ibuprofen mouthwash

EXPERIMENTAL

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

placebo mouthwash

SHAM COMPARATOR

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

Interventions

placebo DRUG

the mouthwash(ibuprofen 2% or placebo) Subgingival Irrigation of mouthwash with an insulin syringe 0.5 ml were rinsed.

Also known as: Ibuprofen 2% mouthwash (made from the Faculty of Pharmaceutical Sciences, Islamic Azad University, Tehran)

placebo mouthwash

Ibuprofen 2% mouthwash DRUG

ibuprofen mouthwash

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Islamic Azad University, Sanandaj: lead

MeSH Terms

Conditions

Periodontitis

Interventions

Ibuprofen; Mouthwashes

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant prof

Study Record Dates

• First Submitted: August 29, 2015
• First Posted: September 2, 2015
• Study Start: November 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: February 1, 2015
• Last Updated: September 2, 2015

Record last verified: 2015-08