Clinical trial NCT06291129: Gingival Health and Malocclusion Among Type 1 Diabetic Children and Adolescents
Official title: Assessment of Oral Hygiene, Gingival Health, and Malocclusion Among Type 1 Diabetic Children and Adolescents: an Original Article
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gingivitis
Periodontal Diseases
Diabetes
Diabetes Mellitus, Type 1
Malocclusion
Malocclusion in Children
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 36
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bleeding on probing
timeFrame: Twenty-one days
Secondary outcomes:
Other outcomes:
Locations:
city: Nova Friburgo
country: Brazil
facility: Universidade Federal Fluminense
state: Rio De Janeiro
Study officials:
affiliation: Universidade Federal Fluminense
name: Gabriela C Cruz, PhD
role: PRINCIPAL_INVESTIGATOR
References: