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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03836781
Other study ID # 2037
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date April 10, 2018
Est. completion date June 15, 2019

Study information

Verified date July 2019
Source Islamic Azad University, Tehran
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, 40 patients with a history of Mild- Periodontitis who were diagnosed with clinical and radiographic findings showed that all of the periodontal parameters before the treatment, during the treatment period Then, scaling & Root planing and oral hygiene instructions were given to the patients, and after 2 weeks, the patients who received the study were randomly divided into two groups (Balanced Block Randomization) with four blocks according to the visit time. To group A, oral chlorohexidine and to B group, the drug Ketorolac was given. 5 mm of the drugs required every 15 days the areas underwent a gingival wash with an insulin syringe, which lasted for 3 months.


Description:

In this study, 40 patients with a history of Mild- Periodontitis who were diagnosed with clinical and radiographic findings showed that all of the periodontal parameters before the treatment, during the treatment period Then, scaling & Root planing and oral hygiene instructions were given to the patients, and after 2 weeks, the patients who received the study were randomly divided into two groups (Balanced Block Randomization) with four blocks according to the visit time. To group A, oral chlorohexidine (Ghol Darou-Tehran) and to B group, the drug Ketorolac (Exir-Boroujerd) was given. 5 mm of the drugs required every 15 days the areas underwent a gingival wash with an insulin syringe, which lasted for 3 months. Pl, BI, PD were evaluated in the study sessions. At the end of the clinical change, a multiple measure ANOVA test was used to compare the preceding and follow-up sessions in both groups, considering the intervention method as Between subject comparison And measured at the time of measurement as a Repeated Factor.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date June 15, 2019
Est. primary completion date June 8, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 45 Years
Eligibility Inclusion Criteria:

40 patients with periodontitis chronic and has a 2 molar symmetrically in the lower jaw pockets of the periodontal depth of at least 5 mm and CAL 1-2 mm in at least one of the surfaces of the teeth, were selected

Exclusion Criteria:

1. systemic disease

2. pregnancy or breastfeeding

3. allergy drug used

4. smoking

5. medication 6. not willing to consent to participate in the study

7-Trismus 8-The type of disease periodontal (Aggressive) 9. History of periodontal treatment in the previous 6 months 10-orthodontic treatment

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ketorolac
Ketorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
Chlorhexidine 2%
Chlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe

Locations

Country Name City State
Iran, Islamic Republic of Amirhossein Farahmand Tehran

Sponsors (1)

Lead Sponsor Collaborator
Amirhossein Farahmand

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pocket depth Clinical periodontal measurements to Williams periodontal probe 3 month
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