NCT03198832

Brief Summary

Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. The aim of this study is to establish whether individuals with DM with or without chronic periodontitis have an increase in oxLDL and what is the influence of periodontal treatment in the reduction of oxLDL with consequent improvement in Diabetes Mellitus parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

4 months

First QC Date

February 6, 2017

Last Update Submit

November 11, 2018

Conditions

Type 2 Diabetes Mellitus With Periodontal Disease

Keywords

Periodontal DiseaseType 2 Diabetes MellitusZ-scanAtherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Probing depth change

    The change in the probing depth will be measure in millimeters before and after the treatment.

    baseline, 90 and 180 days

Secondary Outcomes (6)

  • oxLDL concentration Change

    baseline and 180 days

  • LDL, HDL, Total cholesterol, Triacylglycerol

    baseline and 180 days

  • Plaque index

    baseline, 90 and 180 days

  • Gingival index

    baseline, 90 and 180 days

  • Gingival Recession

    baseline, 90 and 180 days

  • +1 more secondary outcomes

Study Arms (2)

Type 2 diabetes mellitus and periodontitis

SHAM COMPARATOR

periodontal debridement in a single session.

Procedure: Non-surgical periodontal treatment

Type 2 diabetes mellitus and without periodontitis

NO INTERVENTION

maintained every three months.

Interventions

Non-surgical periodontal treatmentPROCEDURE

Debridement in a single session in which patients will be anesthetized and receive scaling and root planing with ultrasound equipment .

Type 2 diabetes mellitus and periodontitis

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • individuals older than 35 years with DM2 diagnosed for more than five years and HbA1c between 7% and 11%;
  • be diagnosed with generalized chronic periodontitis: present at least 6 sites with periodontal pocket and loss of insertion above 5mm and two more bags with loss of insertion above 6mm;
  • present at least 20 teeth;
  • agree to participate in the study and sign the informed consent form

You may not qualify if:

  • patients with cardiovascular diseases, cancer, gastrointestinal disorders, skin diseases, pregnancy, lactation, smoking, arthritis, lupus or other diseases of inflammatory origin;
  • have undergone periodontal treatment in the last 12 months;
  • have made use of antioxidant supplements, anti-inflammatories, or antibiotics within the previous 3 months;
  • make use of medications that can alter the marking and concentration of oxLDL, for example, statins;
  • have changed the medication for glycemic control in the last 3 months;
  • present dental elements with pulpal or periapical inflammation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

São Jose Dos Campos, São Paulo, 12245 000, Brazil

Location

MeSH Terms

Conditions

Periodontal DiseasesDiabetes Mellitus, Type 2Atherosclerosis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Maria Jardini, PhD

    Universidade Estadual Paulista Julio de Mesquita Filho

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective double-blind controlled clinical study with a 6-month follow-up.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2017

First Posted

June 26, 2017

Study Start

May 2, 2016

Primary Completion

August 26, 2016

Study Completion

January 28, 2017

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)