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

NCT06506370 | Completed

• 1 other identifier: ID: 141/2013, March 3, 2013
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Diabetes

Keywords

periodontitis; glycosylated haemoglobin; glycaemic control; nonsurgical periodontal therapy; periodontal disease

Outcome Measures

Primary Outcomes (1)

• Level of glycosylated haemoglobin (HbA1c)

  The HbA1c test is expressed as a percentage, with a normal range being below 5.7%, prediabetes between 5.7% and 6.4%, and diabetes 6.5% or higher.

  All the samples were reviewed at 3 and 6 months after treatment, and all the periodontal and endocrine-metabolic variables mentioned above were noted.

Secondary Outcomes (4)

• Plaque index

  All the samples were reviewed at 3 and 6 months after treatment, and all the periodontal and endocrine-metabolic variables mentioned above were noted.

• Bleeding on probing

  All the samples were reviewed at 3 and 6 months after treatment, and all the periodontal and endocrine-metabolic variables mentioned above were noted.

• Periodontal probing depth

  All the samples were reviewed at 3 and 6 months after treatment, and all the periodontal and endocrine-metabolic variables mentioned above were noted.

• Clinical attachment level

  All the samples were reviewed at 3 and 6 months after treatment, and all the periodontal and endocrine-metabolic variables mentioned above were noted.

Study Arms (2)

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.

Other: nonsurgical periodontal treatment

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.

Other: nonsurgical periodontal treatment

Interventions

nonsurgical periodontal treatment 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.

Control group: Patients without periodontitis and with diabetes.; Test group: Patients with periodontitis and diabetes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thirty diabetic patients (15 periodontal and 15 nonperiodontal patients; 8 women and 22 men; 5 smokers and 25 nonsmokers) with a mean age of 55 years were included in the present study. The mean duration of diabetes was 19 years. The patients were referred by the endocrinology service of the Virgen de la Arrixaca University Hospital in Murcia (Spain) to the University Dental Clinic of the Morales Meseguer Hospital in Murcia (Spain) for periodontal clinical examination by the same trained person (B.M-M.).

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Clínica Odontológica Universitaria

Murcia, 30008, Spain

Location

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor Contratado Doctor Permanente

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: March 4, 2013
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Indefined

Locations

ES (1)