Teh Effect of Subgingival Irrigation Wif Ketorolac and Chlorhexidine in Patients Wif Chronic Periodontist
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ketorolac
Chlorhexidine 2%
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
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:
- systemic disease
- pregnancy or breastfeeding
- allergy drug used
- smoking
- 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
Sites / Locations
- Amirhossein Farahmand
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
ketorolac 3%
chlorhexidine 2%
Arm Description
ketorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
chlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
Outcomes
Primary Outcome Measures
Pocket depth
Clinical periodontal measurements to Williams periodontal probe
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03836781
Brief Title
Teh Effect of Subgingival Irrigation Wif Ketorolac and Chlorhexidine in Patients Wif Chronic Periodontist
Official Title
Comparison of Teh TEMPEffect of Subgingival Irrigation Wif Ketorolac and Chlorhexidine in Patients Wif Chronic Periodontist.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
June 8, 2019 (Actual)
Study Completion Date
June 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amirhossein Farahmand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
split mouth
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ketorolac 3%
Arm Type
Active Comparator
Arm Description
ketorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
Arm Title
chlorhexidine 2%
Arm Type
Other
Arm Description
chlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Group A
Intervention Description
Ketorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine 2%
Other Intervention Name(s)
Group B
Intervention Description
Chlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
Primary Outcome Measure Information:
Title
Pocket depth
Description
Clinical periodontal measurements to Williams periodontal probe
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
systemic disease
pregnancy or breastfeeding
allergy drug used
smoking
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
Facility Information:
Facility Name
Amirhossein Farahmand
City
Tehran
ZIP/Postal Code
19
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Teh Effect of Subgingival Irrigation Wif Ketorolac and Chlorhexidine in Patients Wif Chronic Periodontist
We'll reach out to this number within 24 hrs