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The Effects of Periodontal Therapy on Glycemic Control in Diabetic Patients

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ClinicalTrials.gov Identifier: NCT03783845
Recruitment Status : Completed
First Posted : December 21, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Yasser El Makaky, Taibah University

Brief Summary:
Is the non-surgical periodontal therapy can improve glycemic control in type 2 diabetic patients with chronic periodontitis?

Condition or disease Intervention/treatment Phase
Chronic Periodontitis, Generalized Drug: amoxicillin and metronidazole Phase 4

Detailed Description:

The aim of the present study was to monitor the clinical outcomes and the metabolic response of non-surgical periodontal therapy in patients with chronic periodontitis and uncontrolled type 2 diabetes.

Regarding clinical and metabolic parameters at baseline, no differences were displayed between two groups. However, at 3-months follow-up period the patients within a test group were demonstrated better clinical outcomes than patients in a control group


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of Non -Surgical Periodontal Therapy on Glycemic Control and Periodontal Health in Diabetic Patients With Periodontitis (Randomized Controlled Clinical Trial)
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : March 1, 2016
Actual Study Completion Date : March 30, 2016


Arm Intervention/treatment
Experimental: test group
. metronidazole 400mg,three times daily for two weeks. amoxicillin 500mg,three times daily for two weeks.
Drug: amoxicillin and metronidazole
metronidazole 400mg and amoxicillin 500mg three times daily for two weeks
Other Name: Amoxil and Flagyl

No Intervention: control group
no intervention during study period



Primary Outcome Measures :
  1. glycosylated haemoglobin (HbA1c) [ Time Frame: 3 months ]
    Blood was taken from a peripheral vein to monitor HbA1c using high-performance liquid chromatography



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Diagnosis of diabetes type 2 for more than five years Type 2 diabetes with HbA1c level from 7% to 9% at the last medical evaluation Diagnosis with chronic periodontitis

Exclusion Criteria:

Pregnancy

  • Alcoholism and smoking
  • Presence of any systemic disorders other than hypertension and diabetes
  • Diabetic major complications
  Study Documents (Full-Text)

Documents provided by Yasser El Makaky, Taibah University:

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Responsible Party: Yasser El Makaky, Associated professor, Taibah University
ClinicalTrials.gov Identifier: NCT03783845     History of Changes
Other Study ID Numbers: periodontal therapy and HbA1c
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

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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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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Amoxicillin
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents