Periodontal DiseasesNCT05260814
Comparison of Two Oral Hygiene Routines on the Glycemic Control for Type 2 Diabetes Patients With Chronic Periodontitis
A study testing Electric toothbrush with smart phone app in people with Periodontal Diseases and Diabetes Mellitus, run by Harvard School of Dental Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Periodontal Diseases, Diabetes Mellitus
- What is being tested?
- Electric toothbrush with smart phone app
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Two Oral Hygiene Routines on the Glycemic Control for Type 2 Diabetes Patients With Chronic Periodontitis. A Prospective Randomized Controlled Clinical Trial
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:
Read more
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.
Read the 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
- Being tested
- Electric toothbrush with smart phone app
- Keywords
- periodontitis, diabetes mellitus, electric toothbrush
- Medical subject headings
- Periodontal Diseases, Diabetes Mellitus, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric toothbrush with smart phone appDevice
Scaling and root planing, oral hygiene instructions with use of Sonicare Diamond Clean Smart®.
| Study group | Role | What they receive |
|---|---|---|
| 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®. Receives: Device: Electric toothbrush with smart phone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
probing pocket depth changes
To assess oral health parameters which include clinical measurements and immune-inflammatory cytokines.
Measured: 12 months
cytokine changes
To assess oral health parameters which include clinical measurements and immune-inflammatory cytokines.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control clinical trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260814
- Sponsor's protocol ID
- IRB21-0148
- Status last verified
- Feb 2022
- First submitted
- 25 Jan 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Oral Hygiene Routines on the Glycemic Control for Type 2 Diabetes Patients With Chronic Periodontitis. A Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05260814
- Acronym / sponsor ID
- IRB21-0148
- Conditions
- Periodontal Diseases, Diabetes Mellitus
- Keywords
- periodontitis, diabetes mellitus, electric toothbrush
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Harvard School of Dental MedicineUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Scaling and root planing and oral hygiene instructions with use of manual tools |
| Experimental | Experimental | Device: Electric toothbrush with smart phone appScaling and root planing, oral hygiene instructions with use of Sonicare Diamond Clean Smart®. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electric toothbrush with smart phone appScaling and root planing, oral hygiene instructions with use of Sonicare Diamond Clean Smart®. | Device | Experimental |
Primary outcome
changes in HbA1c
Time frame: 12 months
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.
2 secondary outcomes
probing pocket depth changes
Time frame: 12 months
cytokine changes
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Electric toothbrush with smart phone app in people with Periodontal Diseases and Diabetes Mellitus, run by Harvard School of Dental Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Yu Chen, DDS, DMSc (8575760279, Chia-Yu_Chen@hsdm.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in HbA1c (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.