Evaluation of Non - Surgical Periodontal Therapy in Diabetic Patients.

NCT03764410 | Completed DMC

• 1 other identifier: SantosMU4
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Periodontal Diseases

Keywords

Diabetes mellitus, periodontal diseases, periodontal index

Outcome Measures

Primary Outcomes (2)

• blood test fasting blood glucose

  blood tests were performed at baseline and 90 days after periodontal therapy

  90 days

• blood test for glycated hemoglobin

  blood tests were performed at baseline and 90 days after periodontal therapy

  90 days

Study Arms (2)

Diabetic group DG

EXPERIMENTAL

Non-surgical periodontal treatment with scaling and root coronary planing, oral hygiene instructions and removal of biofilm retention factors

Procedure: Non-surgical periodontal treatment

No diabetic group NG

ACTIVE COMPARATOR

Non-surgical periodontal treatment with scaling and root coronary planing, oral hygiene instructions and removal of biofilm retention factors

Procedure: Non-surgical periodontal treatment

Interventions

Non-surgical periodontal treatment PROCEDURE

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.

Diabetic group DG; No diabetic group NG

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetic patients with chronic periodontitis and Systemically healthy patients with chronic periodontitis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Metropolitana de Santos: lead

Study Sites (1)

Caio Vinicius Gonçalves Roman Torres

Santos, São Paulo, 11015001, Brazil

Location

Related 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.

  PMID: 25623292 BACKGROUND

• 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.

  PMID: 26545069 RESULT

• 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.

  PMID: 25255331 RESULT

• 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.

  PMID: 27068410 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Periodontal Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• CAIO VINICIUS G ROMAN TORRES

  University of Santo Amaro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: December 20, 2016
• Primary Completion: October 15, 2017
• Study Completion: December 30, 2017
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)