Gingival Health and Malocclusion Among Type 1 Diabetic Children and Adolescents

Diabetes Clinical Trial

Official title:

Assessment of Oral Hygiene, Gingival Health, and Malocclusion Among Type 1 Diabetic Children and Adolescents: an Original Article

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06291129
• Other study ID #: CAAE: 61347422.4.0000.5626
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 30, 2022
• Est. completion date: October 30, 2024

Study information

• Verified date: February 2024
• Source: Universidade Federal Fluminense
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Gingivitis
• Malocclusion
• Malocclusion in Children
• Periodontal Diseases

Intervention

Procedure:
• Periodontal therapy
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.

Locations

Country	Name	City	State
Brazil	Universidade Federal Fluminense	Nova Friburgo	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding on probing	Bleeding levels on probing below 10% of the periodontal sites evaluated.	Twenty-one days