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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Chronic Periodontitis Diabetes Mellitus, Type 2

Keywords

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Dental Scaling Blood Glucose Hemoglobin A, Glycosylated

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diabetic group

Subjects with Chronic Periodontitis and Type 2 Diabetes Mellitus treated with non surgical periodontal therapy (Full Mouth Scaling and Root Planing)

Group Type EXPERIMENTAL

Full Mouth Scaling and Root Planing

Intervention Type PROCEDURE

This procedure was performed as described by Quirynen et al. 2005 with some modifications

Nondiabetic group

Subjects with Chronic Periodontitis and without Type 2 Diabetes Mellitus treated with non surgical periodontal therapy (Full Mouth Scaling and Root Planing)

Group Type EXPERIMENTAL

Full Mouth Scaling and Root Planing

Intervention Type PROCEDURE

This procedure was performed as described by Quirynen et al. 2005 with some modifications

Interventions

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Full Mouth Scaling and Root Planing

This procedure was performed as described by Quirynen et al. 2005 with some modifications

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Eduardo Aleixo Figueira

DDS, MSc, PhD, Post-Doctoral Student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bruno CV Gurgel, Doctor

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio Grande do Norte

Locations

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Departamento de Odontologia; Universidade Federal do Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Bruno CV Gurgel, Doctor

Role: CONTACT

Phone: +558432154136

Email: [email protected]

Eduardo A Figueira, Doctor

Role: CONTACT

Phone: +5584999521370

Email: [email protected]

Facility Contacts

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Bruno CV Gurgel, Doctor

Role: primary

Eduardo A Figueira, Doctor

Role: backup

References

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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.

Reference Type BACKGROUND

PMID: 7560400 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12211502 (View on PubMed)

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.

Reference Type DERIVED

PMID: 31102044 (View on PubMed)

Other Identifiers

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U1111-1175-5481

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Diabetic group

Full Mouth Scaling and Root Planing

Nondiabetic group

Full Mouth Scaling and Root Planing

Interventions

Full Mouth Scaling and Root Planing

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Eduardo Aleixo Figueira

Responsible Party

Eduardo Aleixo Figueira

Principal Investigators

Bruno CV Gurgel, Doctor

Locations

Departamento de Odontologia; Universidade Federal do Rio Grande do Norte

Countries

Central Contacts

Bruno CV Gurgel, Doctor

Eduardo A Figueira, Doctor

Facility Contacts

Bruno CV Gurgel, Doctor

Eduardo A Figueira, Doctor

References

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.

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.

Other Identifiers

U1111-1175-5481