Evaluation of Non - Surgical Periodontal Therapy in Diabetic Patients.
Primary Purpose
Diabetes Mellitus, Type 2, Periodontal Diseases
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Non-surgical periodontal treatment
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes mellitus, periodontal diseases, periodontal index
Eligibility Criteria
Inclusion Criteria:
- diabetic patients with chronic periodontitis and Systemically healthy patients with chronic periodontitis
Exclusion Criteria:
- Patients who had any of the following characteristics were excluded from the study: use of orthodontic appliances, smoking, pregnancy or lactation, hepatitis or HIV infection or any other disease that compromises immune functions, immunosuppressive chemotherapy, antibiotics, phenytoin, calcium antagonists, cyclosporine or anti-inflammatory drugs one month before the initial consultation, use of oral contraceptives or hormone replacement, periodontal treatment in the 6 months prior to the start of the study.
Sites / Locations
- Caio Vinicius Gonçalves Roman Torres
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Diabetic group DG
No diabetic group NG
Arm Description
Non-surgical periodontal treatment with scaling and root coronary planing, oral hygiene instructions and removal of biofilm retention factors
Non-surgical periodontal treatment with scaling and root coronary planing, oral hygiene instructions and removal of biofilm retention factors
Outcomes
Primary Outcome Measures
blood test fasting blood glucose
blood tests were performed at baseline and 90 days after periodontal therapy
blood test for glycated hemoglobin
blood tests were performed at baseline and 90 days after periodontal therapy
Secondary Outcome Measures
Full Information
NCT ID
NCT03764410
First Posted
December 3, 2018
Last Updated
January 23, 2020
Sponsor
Universidade Metropolitana de Santos
1. Study Identification
Unique Protocol Identification Number
NCT03764410
Brief Title
Evaluation of Non - Surgical Periodontal Therapy in Diabetic Patients.
Official Title
Evaluation of Periodontal Clinical Parameters and Blood Tests in Diabetic Patients Submitted to Non-surgical Periodontal Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 20, 2016 (Actual)
Primary Completion Date
October 15, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Metropolitana de Santos
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
Unfavorable systemic conditions condition a low resistance of the host to the virulence of the aggressive agent, causing in a periodontal disease and may lead to difficulties in the therapeutic response. The longer the duration of diabetes, it is suggested that greater severity of periodontal disease and loss of insertion. The objective of the present study will be to evaluate the clinical, microbial and immunological characteristics in diabetic subjects with chronic periodontitis submitted to non-surgical periodontal treatment. Will be 120 individuals with chronic periodontitis, including 60 type 2 diabetic subjects and 60 healthy should receive and have access to the informed consent form. Medical and dental clinical examination should be performed and evaluation microbial and immunological properties of gingival fluid and saliva respectively. Non-surgical periodontal therapy with subgingival scaling should be performed in all individuals who will be evaluated at two times: at the beginning and after 90 days of the periodontal therapy with new performing clinical exams and collecting oral samples, oral hygiene instructions will be addressed in two sessions. The data will be subjected to appropriate statistical tests and shall provide a comparison between the times. There seems to be a relationship between type 2 diabetes and periodontal disease and studies that provide the implementation of therapy are essential for clarifying the relationship.
Detailed Description
There is a need for more intense metabolic control of the diabetic patient with periodontal disease, since the destruction of the periodontal tissues may be more aggressive, and a rapid control of the oral infection in these patients is essential to avoid the exacerbation of the metabolic imbalance. The initiation and progression of diabetes probably involve the interaction of a multiplicity of factors, these being hereditary and immunological factors that are governed by environmental factors. It can be observed that there is a lack of awareness of oral complications between diabetics and health care providers, and it is extremely important to understand how diabetes affects oral health and there is a need for regular follow-up of patients with diabetes mellitus by dentists and medical professional. The objective of the present study was to evaluate diabetic individuals with chronic periodontitis submitted to non-surgical periodontal treatment using clinical parameters and blood tests of fasting glycemia and glycated hemoglobin. The study was approved by the Research Committee of the Metropolitan University of Santos, nº 1.806.841 and all the patients involved in the research had access to the informed consent form. The diagnosis of diabetes was obtained through blood tests that test blood glucose levels, thus, before clinical evaluations, and 90 days after the periodontal treatment were performed fasting blood glucose tests. Healthy patients also underwent blood tests. After the anamnesis, periodontal clinical examination was performed by a previously trained and calibrated periodontist. Periodontal clinical parameters were realized. After periodontal therapy, all patients underwent further periodontal and laboratory blood tests. The data obtained were tabulated and received statistical treatment through the Anova and Chi square tests. There seems to be a relationship between type 2 diabetes and periodontal disease and studies that provide the implementation of therapy are essential for clarifying the relationship.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Periodontal Diseases
Keywords
Diabetes mellitus, periodontal diseases, periodontal index
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabetic group DG
Arm Type
Experimental
Arm Description
Non-surgical periodontal treatment with scaling and root coronary planing, oral hygiene instructions and removal of biofilm retention factors
Arm Title
No diabetic group NG
Arm Type
Active Comparator
Arm Description
Non-surgical periodontal treatment with scaling and root coronary planing, oral hygiene instructions and removal of biofilm retention factors
Intervention Type
Procedure
Intervention Name(s)
Non-surgical periodontal treatment
Intervention Description
all the individuals included in the study received periodontal treatment with scaling and root planing with the use of local anesthesia and removal of factors that could cause biofilm retention such as fixed prosthesis, restorations, cervical abrasions. Four weekly sessions lasting 30 minutes each.
Primary Outcome Measure Information:
Title
blood test fasting blood glucose
Description
blood tests were performed at baseline and 90 days after periodontal therapy
Time Frame
90 days
Title
blood test for glycated hemoglobin
Description
blood tests were performed at baseline and 90 days after periodontal therapy
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
diabetic patients with chronic periodontitis and Systemically healthy patients with chronic periodontitis
Exclusion Criteria:
Patients who had any of the following characteristics were excluded from the study: use of orthodontic appliances, smoking, pregnancy or lactation, hepatitis or HIV infection or any other disease that compromises immune functions, immunosuppressive chemotherapy, antibiotics, phenytoin, calcium antagonists, cyclosporine or anti-inflammatory drugs one month before the initial consultation, use of oral contraceptives or hormone replacement, periodontal treatment in the 6 months prior to the start of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CAIO VINICIUS G ROMAN TORRES
Organizational Affiliation
University of Santo Amaro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caio Vinicius Gonçalves Roman Torres
City
Santos
State/Province
SP
ZIP/Postal Code
11015001
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
the data obtained must be presented in manuscript form to be published in a specialized journal of the area
Citations:
PubMed Identifier
25623292
Citation
Izuora K, Ezeanolue E, Schlauch K, Neubauer M, Gewelber C, Umpierrez G. Impact of periodontal disease on outcomes in diabetes. Contemp Clin Trials. 2015 Mar;41:93-9. doi: 10.1016/j.cct.2015.01.011. Epub 2015 Jan 24.
Results Reference
background
PubMed Identifier
26545069
Citation
Simpson TC, Weldon JC, Worthington HV, Needleman I, Wild SH, Moles DR, Stevenson B, Furness S, Iheozor-Ejiofor Z. Treatment of periodontal disease for glycaemic control in people with diabetes mellitus. Cochrane Database Syst Rev. 2015 Nov 6;2015(11):CD004714. doi: 10.1002/14651858.CD004714.pub3.
Results Reference
result
PubMed Identifier
25255331
Citation
Wang X, Han X, Guo X, Luo X, Wang D. The effect of periodontal treatment on hemoglobin a1c levels of diabetic patients: a systematic review and meta-analysis. PLoS One. 2014 Sep 25;9(9):e108412. doi: 10.1371/journal.pone.0108412. eCollection 2014.
Results Reference
result
PubMed Identifier
27068410
Citation
Pranckeviciene A, Siudikiene J, Ostrauskas R, Machiulskiene V. Long-term effect of periodontal surgery on oral health and metabolic control of diabetics. Clin Oral Investig. 2017 Apr;21(3):735-743. doi: 10.1007/s00784-016-1819-y. Epub 2016 Apr 11.
Results Reference
result
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Evaluation of Non - Surgical Periodontal Therapy in Diabetic Patients.
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