Nonsurgical Periodontal Care for Diabetes Patients: A Case-Control Study

NCT ID: NCT06506370

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-04
• Study Completion Date: 2013-12-31

Brief Summary

Diabetes mellitus (DM) and periodontitis are two chronic diseases that are interconnected. The coexistence of these conditions leads to increased severity of periodontitis and challenges in controlling blood glucose levels in diabetic patients. The aim of the present study was to evaluate both the influence of periodontal disease and its treatment in patients with DM in terms of a reduction in glycosylated haemoglobin levels at 3 and 6 months after treatment.

Detailed Description

A sequential, nonprobabilistic, controlled, prospective and longitudinal case-control study was carried out at the University Dental Clinic of the Morales Meseguer Hospital in Murcia, Spain. Thirty diabetic patients were divided into two groups. Participants were assigned to either the periodontal treatment group (test group), which received oral hygiene instructions along with scaling and root planing utilizing ultrasound and Gracey curettes, or the nonperiodontal group (control group), which received oral hygiene instructions along with supragingival removal of plaque and calculus using ultrasound. Periodontal and endocrine-metabolic variables were evaluated at baseline and at 3 and 6 months. Clinical periodontal variables such as the plaque index (PI), bleeding on probing (BOP), periodontal probing depth (PPD), clinical attachment level (CAL), and glycosylated haemoglobin (HbA1c) levels were assessed.

Conditions

Periodontitis; Diabetes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control group: Patients without periodontitis and with diabetes.

Periodontitis was diagnosed in patients who presented with attachment losses due to inflammatory problems greater than or equal to 2 mm at the interproximal level or greater than or equal to 3 mm at the buccal or lingual/palatal level in two or more nonadjacent teeth.

The diagnosis of diabetes was made at the endocrinology service of the Hospital Virgen de la Arrixaca in Murcia.

nonsurgical periodontal treatment

Intervention Type: OTHER

The patients underwent treatment in accordance with the guidelines of the European Federation of Periodontology (EFP). Initially, patients were informed of their condition, educated on oral hygiene practices, and advised to cease detrimental habits such as smoking. Following this, supragingival cleaning was conducted using ultrasound, with manual subgingival instrumentation utilizing a reduced set of Gracey curettes for pockets exceeding 4 mm with persistent bleeding or greater than 6 mm.

Test group: Patients with periodontitis and diabetes.

Periodontitis was diagnosed in patients who presented with attachment losses due to inflammatory problems greater than or equal to 2 mm at the interproximal level or greater than or equal to 3 mm at the buccal or lingual/palatal level in two or more nonadjacent teeth.

The diagnosis of diabetes was made at the endocrinology service of the Hospital Virgen de la Arrixaca in Murcia.

nonsurgical periodontal treatment

Intervention Type: OTHER

The patients underwent treatment in accordance with the guidelines of the European Federation of Periodontology (EFP). Initially, patients were informed of their condition, educated on oral hygiene practices, and advised to cease detrimental habits such as smoking. Following this, supragingival cleaning was conducted using ultrasound, with manual subgingival instrumentation utilizing a reduced set of Gracey curettes for pockets exceeding 4 mm with persistent bleeding or greater than 6 mm.

Interventions

nonsurgical periodontal treatment

The patients underwent treatment in accordance with the guidelines of the European Federation of Periodontology (EFP). Initially, patients were informed of their condition, educated on oral hygiene practices, and advised to cease detrimental habits such as smoking. Following this, supragingival cleaning was conducted using ultrasound, with manual subgingival instrumentation utilizing a reduced set of Gracey curettes for pockets exceeding 4 mm with persistent bleeding or greater than 6 mm.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria:

• The inclusion criteria included individuals who met the following specifications: diagnosed with diabetes mellitus, aged 18 years or older, exhibited moderate or advanced periodontitis (clinical insertion loss of 2 mm interproximally or exceeding 3 mm vestibularly or linguodistally in more than 2 nonadjacent teeth), and possessed an HbA1c level between 5.5 and 11. Additionally, participants were allowed to participate in the study only if they did not have any significant diabetic complications and completed the informed consent forms indicating their willingness to participate in the present study.

Exclusion Criteria:

• The exclusion criteria were as follows: patients previously diagnosed and treated for periodontal disease; pregnant or lactating patients; individuals who had taken antibiotics, antiseptics, or medications that could affect the host response during the month prior to the periodontal assessment; patients with uncontrolled DM; and patients who did not sign the informed consent form.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Arturo Sánchez-Pérez

Profesor Contratado Doctor Permanente

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clínica Odontológica Universitaria

Murcia, , Spain

Countries

Spain

Other Identifiers

ID: 141/2013, March 3, 2013

Identifier Type: -

Identifier Source: org_study_id