Status:
UNKNOWN
Comparison of Two Oral Hygiene Routines on the Glycemic Control for Type 2 Diabetes Patients With Chronic Periodontitis
Lead Sponsor:
Harvard School of Dental Medicine
Conditions:
Periodontal Diseases
Diabetes Mellitus
Eligibility:
All Genders
35+ years
Phase:
NA
Brief 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 diab...
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 healt...
Eligibility Criteria
Inclusion
- Patients age 35 or above.
- A minimum of 16 teeth (not including third molars) exists.
- Diagnosis of moderate to severe periodontitis (stage-II to stage-III chronic periodontitis)
- Clinical attachment loss ≥2mm and probing depths of ≥ 5mm in two or more quadrants in the mouth.
- A minimum of 50% of sites exhibiting bleeding on probing.
- FMX shows bone loss at least 15% \~50% at least one site.
- Diagnosis of type 2 diabetes mellitus (T2DM) with last HbA1c level \> 7%
- Willing to participate in the study and follow all visits.
- Have mobile phones compatible with use of the Philips Sonicare Digital App
Exclusion
- Systemic condition requiring antibiotic prophylaxis prior to any invasive procedure
- Systemic disease other than diabetes that would impair healing such as patients on immunosuppression meds, with autoimmune disease, chemo/radiation therapy within the last 10 years
- Subjects with dental implants
- Subjects with implanted pacemakers/defibrillators
- Subjects on prescription for blood thinners
- Antibiotic use within the last 8 weeks (if subjects get placed on antibiotics due to infection for other unrelated health issues during the study period, this will be recorded)
- Long-term use of non-steroidal anti-inflammatory drugs (NSAIDs)
- Pregnant/nursing
- Smokers
- Fully edentulous in either Maxilla or Mandibular
- Previous periodontal treatment in the last 6 months
- Do not have mobile phones for use with the digital app from Philips
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05260814
Start Date
March 1 2022
End Date
June 1 2023
Last Update
March 2 2022
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