Clinical and Microbiological Evaluation of Periodontal Treatment of Diabetic Patients: A Longitudinal Study

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Clinical and Microbiological Evaluation of Non-surgical Periodontal Treatment of Diabetic and Non-diabetic Patients: A Longitudinal Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02643771
• Other study ID #: U1111-1175-5481
• Status: Recruiting
• Phase: Phase 2
• First received: December 28, 2015
• Last updated: December 30, 2015
• Start date: January 2013
• Est. completion date: October 2017

Study information

• Verified date: December 2015
• Source: Universidade Federal do Rio Grande do Norte
• Contact: Bruno CV Gurgel, Doctor
• Phone: +558432154136
• Email: bcgurgel[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Periodontitis
• Diabetes Mellitus, Type 2
• Periodontitis

Intervention

Procedure:
• Full Mouth Scaling and Root Planing
This procedure was performed as described by Quirynen et al. 2005 with some modifications

Locations

Country	Name	City	State
Brazil	Departamento de Odontologia; Universidade Federal do Rio Grande do Norte	Natal	Rio Grande do Norte

Sponsors (2)

Lead Sponsor	Collaborator
Eduardo Aleixo Figueira	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

López 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of bleeding on probing	The mean percentage of periodontal sites with bleeding on probing	Baseline	No
Primary	Percentage of bleeding on probing	The mean percentage of periodontal sites with bleeding on probing	at three months	No
Primary	Percentage of bleeding on probing	The mean percentage of periodontal sites with bleeding on probing	at six months	No
Primary	Percentage of bleeding on probing	The mean percentage of periodontal sites with bleeding on probing	at nine months	No
Primary	Percentage of bleeding on probing	The mean percentage of periodontal sites with bleeding on probing	at twelve months	No
Primary	Percentage of bleeding on probing	The mean percentage of periodontal sites with bleeding on probing	at eighteen months	No
Primary	Percentage of bleeding on probing	The mean percentage of periodontal sites with bleeding on probing	at twenty four months	No
Secondary	Percentage of visible plaque index	The mean percentage of periodontal sites with visible plaque	Baseline and at three, six, nine, twelve, eighteen and twenty four months	No
Secondary	Probing depth (mm)	The mean of probing depth in millimeters calculated for periodontal sites.	Baseline and at three, six, nine, twelve, eighteen and twenty four months	No
Secondary	Clinical attachment level (mm)	The mean of clinical attachment level in millimeters calculated for periodontal sites.	Baseline and at three, six, nine, twelve, eighteen and twenty four months	No