Universidad de Chile
Santiago, Providencia, Chile
Location status: Recruiting
NCT Number: NCT06895980
The objective of this clinical trial is to evaluate the effect of periodontal treatment on the reduction of glycated hemoglobin levels in adult patients with concurrent type 2 diabetes mellitus and periodontitis.
Non-surgical periodontal treatment and the application of a quality of life survey will be performed and then controls will be carried out for 1 year.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Santiago, Providencia, Chile
Location status: Recruiting
The aim of this clinical trial is to evaluate the effect of periodontal treatment on the reduction of HbA1c levels in adult patients with type 2 diabetes mellitus who are users of the Cardiovascular Health Program and also to measure their quality of life by means of a survey OHIP-14sp.
Non-surgical periodontal treatment and subsequent follow-up of periodontal clinical parameters and HbA1c values at 3, 6, 9 and 12 months will be performed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-surgical periodontal treatment will be performed, with periodontal maintenance therapy at 3, 6, 9 and 12 months, with measurement of glycated hemoglobin at each time and application of the OHIP-14SP oral health-related quality of life survey.
Time frame: 13 months
The glycated hemoglobin (HbA1c) is a blood test that measures the average blood glucose level over the past two to three months, expressed as a percentage. It is used to diagnose diabetes and prediabetes, and to monitor diabetes treatment.
A higher percentage indicates poorer glycemic control. The value will be measured at the beginning of periodontal treatment and during maintenance therapy at 3, 6, 9 and 12 months.
Time frame: 13 months
Use of the OHIP-14 survey questionnaire that assesses people's quality of life in relation to their oral health.
It is administered through questions that quantify the impact of oral disorders. It is based on 7 dimensions: physical pain, functional limitation, psychological discomfort, physical disability, psychological disability, and social disability.
Scores range from 0 to 56 and are obtained by summing the ordinal values of the 14 items. Higher scores indicate a worse quality of life, and lower scores indicate a better quality of life.
The Spanish version has been validated in older adults in Chile. We will apply the survey at the beginning of study and 12 months later.
Time frame: 13 months
Probing depth is the distance between the gingival margin and the bottom of the periodontal pocket. It is measured in millimeters using a periodontal probe.
It is measured at six points on each tooth. The probe is inserted parallel to the root surface in the periodontal pocket. It is moved around the gingival margin. In healthy areas, probing depth should not exceed 3 mm. Depths greater than 3.9 mm may indicate periodontal disease. We will administer this assessment at entry into the study and at 3, 6, 9, and 12 months.
Time frame: 13 months
Clinical attachment loss is the difference between the position of the gum and the probing depth.
It is measured at six points on each tooth using a periodontal probe. It is measured in millimeters.
It is classified according to defined stages:
Stage 1: 1 to 2 millimeters Stage 2: 2 to 3 millimeters Stages 3 and 4: 5 millimeters or more The assessment is performed at admission, and at 3, 6, 9, and 12 months.
Time frame: 13 months
Bleeding on probing is a clinical parameter that indicates inflammation in the connective tissue of the gums.
It is performed with a standardized periodontal probe. It is measured at six sites per tooth. It is a dichotomous variable, considered positive if bleeding occurs, or negative if no bleeding occurs.
A value of less than 10% bleeding from all sites is considered periodontal stability.
It will be assessed at admission and at 3, 6, 9, and 12 months.
Contact information is provided by the study sponsor or research team.
Jorge Gamonal, Specialist in periodontics
CONTACT
Melisa Vera, Specialist in periodontics
CONTACT
+56976442451 ext. +569
University of Chile
Other
Acronym: T2D
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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