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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Periodontitis
• Intervention / Treatment: Other: nonsurgical periodontal 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30008
    • Clinica Odontologica Universitaria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index	The plaque index is a clinical measure used to assess the amount of dental plaque on teeth. It evaluates the thickness and extent of plaque accumulation on the tooth surfaces. Typically, a scoring system is used, ranging from 0 (no plaque) to 3 (abundant plaque)	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	Bleeding on probing (BOP) is a clinical sign used in dentistry to assess gum health. It occurs when gentle probing of the gums around the teeth causes bleeding, indicating inflammation or infection, such as gingivitis or periodontitis.	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	Periodontal probing depth is the measurement of the space between the gum and the tooth, from the top of the gumline to the bottom of the pocket. This is done using a periodontal probe and is used to assess the health of the gums and diagnose periodontal disease. Healthy gums typically have probing depths of 1-3 mm.	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	Clinical attachment level (CAL) is the measurement from the cementoenamel junction (CEJ) to the base of the periodontal pocket. It indicates the extent of periodontal support loss around a tooth, combining probing depth and gum recession. CAL is crucial for diagnosing and monitoring periodontal disease.	All the samples were reviewed at 3 and 6 months after treatment, and all the periodontal and endocrine-metabolic variables mentioned above were noted.

Collaborators and Investigators

• Sponsor: Universidad de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: periodontitis; glycosylated haemoglobin; glycaemic control; nonsurgical periodontal therapy; periodontal disease
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Diabetes Mellitus; Periodontitis
• Other Study ID Numbers: ID: 141/2013, March 3, 2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data of the present study are available as Excel files upon request to the corresponding author (arturosa@um.es).
• IPD Sharing Time Frame: Indefined
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No