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Teh Effect of Subgingival Irrigation Wif Ketorolac and Chlorhexidine in Patients Wif Chronic Periodontist

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ClinicalTrials.gov Identifier: NCT03836781
Recruitment Status : Completed
First Posted : February 11, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Amirhossein Farahmand, Islamic Azad University, Tehran

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Ketorolac Drug: Chlorhexidine 2% Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: split mouth
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Teh TEMPEffect of Subgingival Irrigation Wif Ketorolac and Chlorhexidine in Patients Wif Chronic Periodontist.
Actual Study Start Date : April 10, 2018
Actual Primary Completion Date : June 8, 2019
Actual Study Completion Date : June 15, 2019


Arm Intervention/treatment
Active Comparator: ketorolac 3%
ketorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
Drug: Ketorolac
Ketorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
Other Name: Group A

chlorhexidine 2%
chlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
Drug: Chlorhexidine 2%
Chlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
Other Name: Group B




Primary Outcome Measures :
  1. Pocket depth [ Time Frame: 3 month ]
    Clinical periodontal measurements to Williams periodontal probe



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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836781


Locations
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Iran, Islamic Republic of
Amirhossein Farahmand
Tehran, Iran, Islamic Republic of, 19
Sponsors and Collaborators
Amirhossein Farahmand

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Responsible Party: Amirhossein Farahmand, assistant prof, Islamic Azad University, Tehran
ClinicalTrials.gov Identifier: NCT03836781     History of Changes
Other Study ID Numbers: 2037
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Insulin
Insulin, Globin Zinc
Ketorolac
Ketorolac Tromethamine
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
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