Effects of Gum Disease Treatment on Host Defense Factors

NCT ID: NCT03146975

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-02
• Study Completion Date: 2017-06-28

Brief Summary

Human immune system produces many different factors, which will influence health-disease statuses. This partially explains why under similar conditions only some people become sick. Therefore, specific analyses of such factors in healthy and diseased patients are crucial for a better knowledge about diseases development and successful treatments. Human beta defensins (hBD) may have a key role in patient's susceptibility to gum diseases. In the lab, high levels of sugar (glucose) could inhibit their expression and contribute to the occurrence of infections associated with diabetic wounds. This study will evaluate if treatment of the most common gum disease in adults influences production of beta defensins by gingiva. Also, clinical improvements and treatment effects on blood glycemic levels will be monitored throughout a 2-month period. Patients with or without gum diseases and with or without diabetes mellitus will be able to participate. After a complete oral examination to determine periodontal status, gingival fluid samples will be collected using paper strips. These samples will be collected before and also two-months after oral treatment and will be analyzed by an immune-enzymatic test named ELISA (Enzyme-Linked Immunosorbent Assay). In weekly sections, one trained specialist will performed treatment of gum diseases under local anesthesia using hand-instruments. Researchers hypothesized that a) levels of defensins would be lower in the presence of periodontal disease when compared to a healthy periodontal condition; b) diabetes would influence production of these immune protective factors; and c) treatment would provide a greater beneficial amount of defensins.

Conditions

Periodontitis; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Healthy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Periodontitis without diabetes

Group Type: EXPERIMENTAL

Non-surgical periodontal treatment

Intervention Type: PROCEDURE

Quadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions.

Periodontitis compensated diabetes

Group Type: EXPERIMENTAL

Non-surgical periodontal treatment

Intervention Type: PROCEDURE

Quadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions.

Periodontitis decompensated diabetes

Group Type: EXPERIMENTAL

Non-surgical periodontal treatment

Intervention Type: PROCEDURE

Quadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions.

Compensated diabetes non periodontitis

Group Type: NO_INTERVENTION

No interventions assigned to this group

Decompensated diabetes non periodontitis

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Non-surgical periodontal treatment

Quadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Periodontally healthy individuals: at least 15 natural teeth, periodontal pocket depth (PPD) ≤ 3mm e absence of bleeding on probing.
• Periodontitis individuals: at least 15 natural teeth and at least 4 teeth with one or more periodontal sites showing combined PPD ≥ 4mm and clinical attachment level (CAL) ≥ 3mm.
• Compensated diabetic individuals: compensated type 2 diabetes mellitus
• Decompensated diabetic individuals: decompensated type 2 diabetes mellitus (glycated hemoglobin HbA1c >7%)

Exclusion Criteria

• Past or actual systemic diseases other than diabetes type 2 in the diabetic groups
• Gingivitis
• Gingival overgrowth
• Necrotizing periodontal diseases
• Pregnant or lactating
• smokers or former-smokers
• medication that can influence periodontal status or host response to periodontal therapy
• periodontal therapy in the past 6 months from baseline
• use of systemic or local antibiotics or anti-inflammatory drugs within 3 months prior baseline

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Fernando O Costa

Head of periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando O Costa, PhD

Role: PRINCIPAL_INVESTIGATOR

Dean periodontics department

Locations

Federal university of minas gerais

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

Beta defensins in periodontics

Identifier Type: -

Identifier Source: org_study_id