- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06291129
Gingival Health and Malocclusion Among Type 1 Diabetic Children and Adolescents
February 26, 2024 updated by: Gabriela Alessandra da Cruz Galhardo Camargo, Universidade Federal Fluminense
Assessment of Oral Hygiene, Gingival Health, and Malocclusion Among Type 1 Diabetic Children and Adolescents: an Original Article
Introduction: This study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes.
Methods: The sample consisted of 36 children, who were distributed into two groups: DM; n=18 and NDM; n=18.
Periodontal parameters considered were plaque Index (PI), gingival Index (GI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL).
Gingival biotype clinical parameters: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars.
Malocclusion were evaluated by the Dental Aesthetic Index (DAI) and the Angle's Classification.
The statistical analyses were Shapiro Wilk test and T test.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Introduction: This study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes.
Methods: The sample consisted of 36 children (age 8 to 18 years old), who were distributed into two groups: patients with type 1 diabetes (DM; n=18) and control patients without diabetes (NDM; n=18).
Periodontal parameters considered were plaque Index (PI), gingival Index (GI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL).
Gingival biotype clinical parameters were evaluated by three aspects: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars.
Malocclusion, its prevalence, severity and need of treatment were evaluated by the Dental Aesthetic Index (DAI) and the Angle's Classification.
The statistical analyses were Shapiro Wilk test and T test.
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rio De Janeiro
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Nova Friburgo, Rio De Janeiro, Brazil, 28625650
- Universidade Federal Fluminense
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- child or adolescent with the age between 8 and 18 years old
Exclusion Criteria:
- child or adolescent who had an active or inactive caries lesion, on the buccal surface, in the cervical region of the elements to be analyzed;
- participants with probing depth greater than or equal to 4 mm, which is characterized as periodontitis;
- the patient who is undergoing orthodontic treatment, with fixed appliance;
- smokers;
- pregnant women, nursing mothers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Hematological and Periodontal Parameters
Hematological parameters were recorded - fasting blood glucose and glycosylated hemoglobin - to confirm the allocation of each participant between the groups: diabetic (DM) and control (NDM).
The clinical periodontal parameters, including plaque index (PI) and bleeding on probing (GI) full mouth (Ainamo & Bay 1975), and plaque index (PI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL).
Gingival biotype clinical parameters were evaluated by three aspects: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars.
For the periodontal parameters' examination, a periodontal probe PCP15 (PCP-UNC15, Hu-Friedy, Chicago, IL) was used, excluding third molars and erupting teeth.
The intraexaminer agreement of the categorical variables (CAL) using the kappa calculation was 7.64, at the tooth level.
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Supragingival scaling sessions were performed with ultrasonic scalers (Dabi Atlante, Rio de Janeiro, RJ, Brazil) to remove all calculus and biofilms, in addition to oral hygiene guidelines, including brushing technique and interdental cleaning with dental floss.
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No Intervention: Orthodontic Parameters
The clinical orthodontic parameters were recorded by the Angle's Classification, witch evaluated occlusion of right and left canines and molars, and the Dental Aesthetic Index (DAI) that evaluates the prevalence of malocclusions, its severity and the need for treatment.
DAI aspects evaluated were: upper teeth loss, lower teeth loss, crowding, spacing, diastema, maxillary misalignment, mandibular misalignment, anterior maxillary overjet, anterior mandibular overjet, anterior open bite, molar relationship.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bleeding on probing
Time Frame: Twenty-one days
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Bleeding levels on probing below 10% of the periodontal sites evaluated.
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Twenty-one days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gabriela C Cruz, PhD, Universidade Federal Fluminense
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2022
Primary Completion (Actual)
October 30, 2023
Study Completion (Estimated)
October 30, 2024
Study Registration Dates
First Submitted
November 20, 2023
First Submitted That Met QC Criteria
February 26, 2024
First Posted (Estimated)
March 4, 2024
Study Record Updates
Last Update Posted (Estimated)
March 4, 2024
Last Update Submitted That Met QC Criteria
February 26, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE: 61347422.4.0000.5626
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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