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Completed

NCT Number: NCT06506370

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.

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Key information

Conditions

Periodontitis Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica Odontológica Universitaria

Murcia, 30008, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Level of glycosylated haemoglobin (HbA1c)

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

    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.

Secondary outcomes

  1. Plaque index

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

    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)

  2. Bleeding on probing

    Time frame: 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 (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.

  3. Periodontal probing depth

    Time frame: 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 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.

  4. Clinical attachment level

    Time frame: 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 (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.

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 17, 2024
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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