Evaluation of Non - Surgical Periodontal Therapy in Diabetic Patients.

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Evaluation of Periodontal Clinical Parameters and Blood Tests in Diabetic Patients Submitted to Non-surgical Periodontal Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764410
• Other study ID #: SantosMU4
• Status: Completed
• Phase: N/A
• Start date: December 20, 2016
• Est. completion date: December 30, 2017

Study information

• Verified date: January 2020
• Source: Universidade Metropolitana de Santos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 30, 2017
• Est. primary completion date: October 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Periodontal Diseases

Intervention

Procedure:
• Non-surgical periodontal treatment
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.

Locations

Country	Name	City	State
Brazil	Caio Vinicius Gonçalves Roman Torres	Santos	SP

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Metropolitana de Santos

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View 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. — View 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;(11):CD004714 — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood test fasting blood glucose	blood tests were performed at baseline and 90 days after periodontal therapy	90 days
Primary	blood test for glycated hemoglobin	blood tests were performed at baseline and 90 days after periodontal therapy	90 days