Clinical and Microbiological Evaluation of Periodontal Treatment of Diabetic Patients: A Longitudinal Study
Primary Purpose
Chronic Periodontitis, Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Full Mouth Scaling and Root Planing
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Periodontitis focused on measuring Dental Scaling, Blood Glucose, Hemoglobin A, Glycosylated
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of chronical periodontitis according to Lopez et al. 2002 (one or more teeth with at least one site with PD >= 4mm or CAL >= 3mm);
- And have at least 8 natural teeth (excluding third molars), and older than 18 years and of both genders.
Exclusion Criteria:
- Any systemic diseases or complications (except Type 2 Diabetes Mellitus) such as cardiovascular disease, Alzheimer's, lung or brain diseases and metabolic syndrome;
- Use of antibiotics or periodontal treatment within the past 6 months;
- Long-term administration of anti-inflammatory or/and immunosuppressive agents;
- Current smoker or former smoker for the past 5 years;
- Pregnant or breastfeeding;
- And presence of orthodontic appliances.
Sites / Locations
- Departamento de Odontologia; Universidade Federal do Rio Grande do NorteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Diabetic group
Nondiabetic group
Arm Description
Subjects with Chronic Periodontitis and Type 2 Diabetes Mellitus treated with non surgical periodontal therapy (Full Mouth Scaling and Root Planing)
Subjects with Chronic Periodontitis and without Type 2 Diabetes Mellitus treated with non surgical periodontal therapy (Full Mouth Scaling and Root Planing)
Outcomes
Primary Outcome Measures
Percentage of bleeding on probing
The mean percentage of periodontal sites with bleeding on probing
Percentage of bleeding on probing
The mean percentage of periodontal sites with bleeding on probing
Percentage of bleeding on probing
The mean percentage of periodontal sites with bleeding on probing
Percentage of bleeding on probing
The mean percentage of periodontal sites with bleeding on probing
Percentage of bleeding on probing
The mean percentage of periodontal sites with bleeding on probing
Percentage of bleeding on probing
The mean percentage of periodontal sites with bleeding on probing
Percentage of bleeding on probing
The mean percentage of periodontal sites with bleeding on probing
Secondary Outcome Measures
Percentage of visible plaque index
The mean percentage of periodontal sites with visible plaque
Probing depth (mm)
The mean of probing depth in millimeters calculated for periodontal sites.
Clinical attachment level (mm)
The mean of clinical attachment level in millimeters calculated for periodontal sites.
Full Information
NCT ID
NCT02643771
First Posted
December 28, 2015
Last Updated
December 30, 2015
Sponsor
Eduardo Aleixo Figueira
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
1. Study Identification
Unique Protocol Identification Number
NCT02643771
Brief Title
Clinical and Microbiological Evaluation of Periodontal Treatment of Diabetic Patients: A Longitudinal Study
Official Title
Clinical and Microbiological Evaluation of Non-surgical Periodontal Treatment of Diabetic and Non-diabetic Patients: A Longitudinal Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eduardo Aleixo Figueira
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether periodontal treatment improves the periodontal clinical parameters in the periodontal patients with diabetes regarding non-diabetics: two years follow-up.
Detailed Description
All the subjects in the study will receive non surgical periodontal treatment in one session (full-mouth scaling and root planing). Clinical parameters will be assessed in all teeth (except third molars) by one experienced and trained examiner before treatment and every 3 months for 2 years. Visible plaque index (VPI) will be represented a mean percentage of sites with visible plaque calculated for all teeth analyzed (four sites per tooth). Others parameters will be assessed at six sites per tooth using a manual periodontal probe (15mm). Bleeding on probing (BOP) will be represented the mean percentage of sites with bleeding (up to 15 seconds after probing) calculated for all teeth analyzed. Probing depth (PD - distance between the gingival margin and the bottom of the sulcus/pocket), gingival recession (GR - distance between the cementoenamel junction and gingival margin) and clinical attachment level (CAL - distance between the cementoenamel junction and the bottom of the sulcus/pocket) will be represented a mean distance calculated per site for all teeth analyzed. For blood parameters, an outside laboratory will perform all blood analysis. It will be requested for each subject with diabetes (DG) at baseline, each 3 months post-treatment. Fasting plasma glucose (FPG) will be expressed in milligrams per deciliter and HbA1c will be expressed as a percentage. Statistical analysis will be performed using an available software program and the patient will be considered as the unit of analysis.The data will be processed and analyzed by descriptive and inferential statistics, probably nonparametric.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Diabetes Mellitus, Type 2
Keywords
Dental Scaling, Blood Glucose, Hemoglobin A, Glycosylated
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diabetic group
Arm Type
Experimental
Arm Description
Subjects with Chronic Periodontitis and Type 2 Diabetes Mellitus treated with non surgical periodontal therapy (Full Mouth Scaling and Root Planing)
Arm Title
Nondiabetic group
Arm Type
Experimental
Arm Description
Subjects with Chronic Periodontitis and without Type 2 Diabetes Mellitus treated with non surgical periodontal therapy (Full Mouth Scaling and Root Planing)
Intervention Type
Procedure
Intervention Name(s)
Full Mouth Scaling and Root Planing
Intervention Description
This procedure was performed as described by Quirynen et al. 2005 with some modifications
Primary Outcome Measure Information:
Title
Percentage of bleeding on probing
Description
The mean percentage of periodontal sites with bleeding on probing
Time Frame
Baseline
Title
Percentage of bleeding on probing
Description
The mean percentage of periodontal sites with bleeding on probing
Time Frame
at three months
Title
Percentage of bleeding on probing
Description
The mean percentage of periodontal sites with bleeding on probing
Time Frame
at six months
Title
Percentage of bleeding on probing
Description
The mean percentage of periodontal sites with bleeding on probing
Time Frame
at nine months
Title
Percentage of bleeding on probing
Description
The mean percentage of periodontal sites with bleeding on probing
Time Frame
at twelve months
Title
Percentage of bleeding on probing
Description
The mean percentage of periodontal sites with bleeding on probing
Time Frame
at eighteen months
Title
Percentage of bleeding on probing
Description
The mean percentage of periodontal sites with bleeding on probing
Time Frame
at twenty four months
Secondary Outcome Measure Information:
Title
Percentage of visible plaque index
Description
The mean percentage of periodontal sites with visible plaque
Time Frame
Baseline and at three, six, nine, twelve, eighteen and twenty four months
Title
Probing depth (mm)
Description
The mean of probing depth in millimeters calculated for periodontal sites.
Time Frame
Baseline and at three, six, nine, twelve, eighteen and twenty four months
Title
Clinical attachment level (mm)
Description
The mean of clinical attachment level in millimeters calculated for periodontal sites.
Time Frame
Baseline and at three, six, nine, twelve, eighteen and twenty four months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of chronical periodontitis according to Lopez et al. 2002 (one or more teeth with at least one site with PD >= 4mm or CAL >= 3mm);
And have at least 8 natural teeth (excluding third molars), and older than 18 years and of both genders.
Exclusion Criteria:
Any systemic diseases or complications (except Type 2 Diabetes Mellitus) such as cardiovascular disease, Alzheimer's, lung or brain diseases and metabolic syndrome;
Use of antibiotics or periodontal treatment within the past 6 months;
Long-term administration of anti-inflammatory or/and immunosuppressive agents;
Current smoker or former smoker for the past 5 years;
Pregnant or breastfeeding;
And presence of orthodontic appliances.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno CV Gurgel, Doctor
Phone
+558432154136
Email
bcgurgel@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo A Figueira, Doctor
Phone
+5584999521370
Email
edufigueira@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno CV Gurgel, Doctor
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departamento de Odontologia; Universidade Federal do Rio Grande do Norte
City
Natal
State/Province
Rio Grande do Norte
ZIP/Postal Code
59056-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno CV Gurgel, Doctor
Phone
+558432154136
Email
bcgurgel@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Eduardo A Figueira, Doctor
Phone
+5584999521370
Email
edufigueira@yahoo.com.br
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
7560400
Citation
Quirynen M, Bollen CM, Vandekerckhove BN, Dekeyser C, Papaioannou W, Eyssen H. Full- vs. partial-mouth disinfection in the treatment of periodontal infections: short-term clinical and microbiological observations. J Dent Res. 1995 Aug;74(8):1459-67. doi: 10.1177/00220345950740080501.
Results Reference
background
PubMed Identifier
12211502
Citation
Lopez NJ, Smith PC, Gutierrez J. Periodontal therapy may reduce the risk of preterm low birth weight in women with periodontal disease: a randomized controlled trial. J Periodontol. 2002 Aug;73(8):911-24. doi: 10.1902/jop.2002.73.8.911.
Results Reference
background
PubMed Identifier
31102044
Citation
Almeida ML, Duarte PM, Figueira EA, Lemos JC, Nobre CMG, Miranda TS, de Vasconcelos Gurgel BC. Effects of a full-mouth disinfection protocol on the treatment of type-2 diabetic and non-diabetic subjects with mild-to-moderate periodontitis: one-year clinical outcomes. Clin Oral Investig. 2020 Jan;24(1):333-341. doi: 10.1007/s00784-019-02927-8. Epub 2019 May 17.
Results Reference
derived
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Clinical and Microbiological Evaluation of Periodontal Treatment of Diabetic Patients: A Longitudinal Study
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