NCT05260814

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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

January 25, 2022

Last Update Submit

February 18, 2022

Conditions

Periodontal DiseasesDiabetes Mellitus

Keywords

periodontitisdiabetes mellituselectric toothbrush

Outcome Measures

Primary Outcomes (1)

  • changes in HbA1c

    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.

    12 months

Secondary Outcomes (2)

  • probing pocket depth changes

    12 months

  • cytokine changes

    12 months

Study Arms (2)

Control

NO INTERVENTION

Scaling and root planing and oral hygiene instructions with use of manual tools

Experimental

EXPERIMENTAL

Scaling and root planing, oral hygiene instructions with use of Sonicare Diamond Clean Smart®.

Device: Electric toothbrush with smart phone app

Interventions

Electric toothbrush with smart phone appDEVICE

Scaling and root planing, oral hygiene instructions with use of Sonicare Diamond Clean Smart®.

Experimental

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontal DiseasesDiabetes MellitusPeriodontitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Chia-Yu Chen, DDS, DMSc

CONTACT

8575760279Chia-Yu_Chen@hsdm.harvard.edu

Nagai Shigemi, DMD, PhD

CONTACT

6174321434shigemi_nagai@hsdm.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2022

First Posted

March 2, 2022

Study Start

March 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

March 2, 2022

Record last verified: 2022-02