Aim: To evaluate the effect of ibuprofen gel, and placebo for inhibition of bone loss in chronic periodontitis.
Materials and Methods: In this study of 22 patients with no systemic disease and periodontal probing depth at a rate of at least 4 mm were participated in the study, periodontal parameters (plaque, bleeding on probing and pocket depth) were recorded at baseline and every 15 days for 3 months. The patients were treated with scaling and rootplaning at the baseline; Oral hygiene instructions were given that included brushing twice- daily, (Using the Bass brushing technique for at least 2 minutes ), And then each side of the mandible of the patients were randomly divided into two groups, and Then each side of the mandible of the patients were randomly divided into two groups, The experimental group: receiving 2% ibuprofen gel (Diomed Pharmaceutical Company-U.K) and The control group: receiving placebo; 0.5 ml of the gel (Ibuprofen or Placebo) which were inserted into the periodontal pocket using an insulin syringe respectively, Repeated to the both groups every 15 days for 3 months; The clinical and radiographic parameters are evaluated after completion clinical trial .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050517587N1
Registration date:2014-06-17, 1393/03/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-17, 1393/03/27
Registrant information
Name
Amirhossein Farahmand
Name of organization / entity
Dental Branch Islamic Azad University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2284 9604
Email address
perio-implant@hotmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-10-16, 1391/07/25
Expected recruitment end date
2013-12-16, 1392/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of localized ibuprofen gel compared with placebo for inhibition of bone loss in chronic periodontitis.
Public title
Randomized, double blind, placebo controlled clinical study to evaluate of
topical ibuprofen gel for the inhibition of bone loss in chronic periodontitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Systemically healthy patients with chronic periodontitis with periodontal pockets 4 millimeters deep or more at the both sides of posterior teeth in Mandibular Jaw.
Exclusion Criteria: Existing systemic disease; Pregnancy; Lactation; Smokers; Patients who had taken any kind of medication during the previous six months; No periodontal treatment the previous six months; Hypersensitive to Ibuprofen; Orthodontic treatment; Cancer and Chemotherapy; Numerous large caries; The use of any mouthwash during the study.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Dental Branch, Islamic Azad University of Tehran
Street address
No 4, 10th Neyestan, Pasdaran Ave, Tehran, Iran
City
Tehran
Postal code
19585/175
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
508
Health conditions studied
1
Description of health condition studied
Periodontal diseases
ICD-10 code
K05.3
ICD-10 code description
Periodontal diseases
Primary outcomes
1
Description
Pocket depth
Timepoint
15 Days
Method of measurement
Periodontal Probe
2
Description
Bleeding on probing
Timepoint
15
Method of measurement
Periodontal Probe
Secondary outcomes
1
Description
Increased alveolar bone density
Timepoint
3 months
Method of measurement
Bone densitometer machine
2
Description
Reduction of plaque index
Timepoint
3 Months
Method of measurement
Loe & Silness Index
Intervention groups
1
Description
The ibuprofen gel (Diomed Pharmaceutical Company- England); which be put into the periodontal pocket using an insulin syringe .
Category
Treatment - Drugs
2
Description
The placebo gel of was prepared in the same manner but without the active drug in it; (made of faculty of Islamic Azad University of Pharmaceutical Sciences); which be put into the periodontal pocket using an insulin syringe.