Gingival Health and Malocclusion Among Type 1 Diabetic Children and Adolescents

Not Applicable

Active, not recruiting

• Conditions: Diabetes; Malocclusion; Diabetes Mellitus, Type 1; Malocclusion in Children; Gingivitis; Periodontal Diseases
• Interventions: Procedure: Periodontal therapy

• Registration Number: NCT06291129
• Lead Sponsor: Universidade Federal Fluminense

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.

Study Timeline

• Study Start: 2022-10-30
• Primary Completion: 2023-10-30
• Study First Submitted: 2023-11-20
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-26
• Last Update Submitted: 2024-02-26
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-04
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hematological and Periodontal Parameters	Periodontal therapy	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.

Primary Outcome Measures

Name	Time	Method
Bleeding on probing	Twenty-one days	Bleeding levels on probing below 10% of the periodontal sites evaluated.

Trial Locations

Locations (1)

Universidade Federal Fluminense; 🇧🇷 Nova Friburgo, Rio De Janeiro, Brazil