Clinical trial NCT06506370: Nonsurgical Periodontal Care for Diabetes Patients: A Case-Control Study
Official title: Nonsurgical Periodontal Care for Diabetes Patients: A Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Diabetes
Keywords: periodontitis; glycosylated haemoglobin; glycaemic control; nonsurgical periodontal therapy; periodontal disease
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.).

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.

Eligibility 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.

Primary outcomes:
measure: Level of glycosylated haemoglobin (HbA1c)
timeFrame: 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:
measure: Plaque index
timeFrame: All the samples were reviewed at 3 and 6 months after treatment, and all the periodontal and endocrine-metabolic variables mentioned above were noted.
measure: Bleeding on probing
timeFrame: All the samples were reviewed at 3 and 6 months after treatment, and all the periodontal and endocrine-metabolic variables mentioned above were noted.
measure: Periodontal probing depth
timeFrame: All the samples were reviewed at 3 and 6 months after treatment, and all the periodontal and endocrine-metabolic variables mentioned above were noted.
measure: Clinical attachment level
timeFrame: All the samples were reviewed at 3 and 6 months after treatment, and all the periodontal and endocrine-metabolic variables mentioned above were noted.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Clínica Odontológica Universitaria
Study officials:
References: