NCT05260814

Comparison of Two Oral Hygiene Routines on the Glycemic Control for Type 2 Diabetes Patients With Chronic Periodontitis

Comparison of Two Oral Hygiene Routines on the Glycemic Control for Type 2 Diabetes Patients With Chronic Periodontitis. A Prospective Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Harvard School of Dental Medicine · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare two common oral hygiene routines on the improvement of glycemic control and oral health parameters in moderate to severe periodontitis patients with uncontrolled type 2 diabetes (T2DM). It is currently unclear if one oral hygiene routine is more effective than the other. The two routines being compared are: Group 1: Scaling and root planing + oral hygiene routine with use of an electric toothbrush (Sonicare Diamond Clean Smart ®) along with its mobile app Group 2: Scaling and root planing + oral hygiene routine with use of manual toothbrush The specific aims of the study are: Aim 1: To assess the impact of Sonicare Diamond Clean Smart ® use on the glycemic control as an adjunct to scaling and root planing and oral hygiene instructions for T2DM patients with moderate to severe periodontitis patients. Aim 2: To assess oral health parameters which include clinical measurements and immune-inflammatory cytokines.

Detailed description

Background Periodontitis is among the most prevalent chronic diseases in the world and it affects more than 50% of Americans. On the other hand, type 2 diabetes mellitus (T2DM) is a major public health concern, affecting 347 million adults worldwide. This number will likely double by the year 2030 with diabetes-related health care expenditure amount to 15%. The relationship between periodontal diseases and diabetes has been well-established. Treatment of periodontal diseases improves diabetes outcomes. To treat and prevent gingivitis as well as periodontal disease, microbial plaque biofilm control is essential. A classic study done in 1965 clearly demonstrated the relationship between plaque accumulation when subjects stopped brushing and the development of gingivitis in humans. Adherence to oral hygiene care by the patient is an important part in the maintenance of periodontal health. Oral hygiene reinforcement through repeated oral hygiene instructions as well as psychological interventions have shown to have positive effects on oral hygiene improvement. Rapid communication, health information access and monitoring have been made possible through the various innovations in mobile device. However, at present, no studies have investigated the impact of the incorporation of electric-toothbrush and smart device for self-monitoring for the periodontal treatment outcomes on diabetes patients. It is currently unclear whether a toothbrush with smartphone application that incorporates self-efficacy and behavioral modification will result in improved clinical parameters, reduction in inflammation and periodontal pathogens in blood as well as glycemic control for these patients. Specific Aims This study aims to investigate the efficacy of Sonicare Diamond Clean Smart ® on the improvement of glycemic control and oral health parameters in moderate to severe periodontitis patients with uncontrolled type 2 diabetes (T2DM). The primary objective of this study is to assess the efficacy of Sonicare Diamond Clean Smart ® on the glycemic control as an adjunct to scaling and root planing and oral hygiene instructions for T2DM patients with moderate to severe periodontitis patients. The secondary objective is to assess oral health parameters which include clinical measurements and immune-inflammatory cytokines. The two groups being compared are: • Experiment group: Scaling and root planing, oral hygiene instructions with use of Sonicare Diamond Clean Smart®. • Control group: Scaling and root planing and oral hygiene instructions with use of manual tools. Study Design The study protocol will be submitted for approval by the Harvard Medical School IRB committee. The study will begin following IRB approval. Forty subjects (40) with moderate to severe periodontal disease and diagnosed with uncontrolled type 2 diabetes mellitus (T2DM) will be recruited into study. Of these, twenty will be randomized into experimental group while the other twenty will be randomized into control group.

Conditions

• Periodontal Diseases
• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Electric toothbrush with smart phone app	Scaling and root planing, oral hygiene instructions with use of Sonicare Diamond Clean Smart®.

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2022-03-02
• Last updated: 2022-03-02