Gingival Health and Malocclusion Among Type 1 Diabetic Children and Adolescents

NCT06291129 | Active Not Recruiting DMC

• 1 other identifier: CAAE: 61347422.4.0000.5626
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Bleeding on probing

  Bleeding levels on probing below 10% of the periodontal sites evaluated.

  Twenty-one days

Study Arms (2)

Hematological and Periodontal Parameters

OTHER

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.

Procedure: Periodontal therapy

Orthodontic Parameters

NO INTERVENTION

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.

Interventions

Periodontal therapy PROCEDURE

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.

Hematological and Periodontal Parameters

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- child or adolescent with the age between 8 and 18 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Universidade Federal Fluminense

Nova Friburgo, Rio de Janeiro, 28625650, Brazil

Location

MeSH Terms

Conditions

Gingivitis; Periodontal Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Malocclusion

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Tooth Diseases

Study Officials

• Gabriela C Cruz, PhD

  Universidade Federal Fluminense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: March 4, 2024
• Study Start: October 30, 2022
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)