Diabetes Mellitus, Type IIPhase 2DMRCTNCT04830969

Impact of Periodontal Therapy on Patients With Diabetes

A Phase 2 study testing Chlorhexidine gluconate oral rinse, Scaling & Root Planing and Soft Picks in people with Diabetes Mellitus, Type II and Periodontitis, run by State University of New York at Buffalo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 years and older
Conditions the study is for: Diabetes Mellitus, Type II, Periodontitis
What is being tested?: Chlorhexidine gluconate oral rinse, Scaling & Root Planing and Soft Picks
Type of treatment: Pill or oral medicine, Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 116 participants
Where: 1 siteUnited States
Study dates: 8 Nov 2016to 28 Jan 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 25 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be able to understand the informed consent form and be willing and able to read and sign it.
At least 25 years of age.
Be able to understand and follow directions for study procedures.
At least 14 natural teeth, not counting third molars ("wisdom teeth").
At least 2 interproximal sites with CAL >= 4 mm or at least 2 interproximal sites with PD >= 5 mm.

Who cannot join

Presence of orthodontic appliances ("braces").
An abnormal condition of lips, lining of the mouth, tongue, or gums (except for periodontal disease). If subject has a cold sore, canker sore, or injury in their mouth, they may return after the sore or injury heals.
Abscess of the gingiva caused by periodontal disease, or visible gross tooth decay
A broken tooth root or an abscessed tooth. Subject may be allowed to participate in the study after the condition is successfully treated.
Periodontal treatment or antibiotic therapy in the past 6 months.
Have used cigarettes or other tobacco products in the past year.

Show all 13Show fewer

Body mass index (BMI) is > 40.
Have regularly used non-steroidal anti-inflammatory drugs (such as >= 325 mg aspirin or ibuprofen) over the past 3 weeks.
Regularly using drugs that weaken the immune system (such as corticosteroids taken by mouth or injection, and cyclosporine).
Have participated in another clinical research study in the past 30 days.
Pregnant or breastfeeding.
Have a condition that we feel will make study participation unsafe or difficult for the patient.
Require premedication for dental exams.

Trial locations and contacts

1 site in 1 country.

United States1 site

University at Buffalo
Buffalo, New York, 14214

Other trials in United States

About this study

Official title: Impact of Periodontal Therapy on Patients With Diabetes: A Pilot Study

With poorly controlled diabetes, periodontal status often worsens, and with severe periodontal conditions there is often poorer glycemic control. There are few published reports investigating the efficacy of periodontal therapy in diabetics and fewer that include evaluation of the oral microbial profiles (the microbiome). The investigators will examine systemic changes in diabetes status and microbiome influences on clinical response to periodontal therapy in a randomized clinical trial of participants with and without diabetes and with periodontal disease. Two different treatments will be used:

Scaling and root planning (SRP) alone, or
SRP and supportive periodontal therapy (SPT), the use of chlorhexidine gluconate rinse (Paroex®) and a rubber interdental bristle cleaner (Soft-Picks) The main goal of this clinical trial is to evaluate the effects of SRP alone versus SRP+SPT on clinical, microbiological and immunological status in participants. A clearer understanding of how periodontal therapy affects diabetes status could lead to the development of new therapies for periodontal disease and diabetes.

Read the detailed description

With poorly controlled diabetes, periodontal disease worsens, and with severe periodontal conditions, there is often poorer glycemic control. Published papers conclude that periodontal treatment leads to a reduction in hemoglobin A1c; however, other studies show limited or no improvement. Some patients do not respond well to professional periodontal therapy, even without diabetes, which could be related to poor oral hygiene and/or host factors including microbial profiles. There are few published papers investigating the efficacy of periodontal therapy in diabetics and fewer that include assessment of the oral microbiome. The investigators will examine systemic changes in diabetes status and microbiome influences on clinical response to periodontal therapy in a randomized clinical trial. It has been shown that chlorhexidine gluconate rinse leads to significant clinical improvement over standard periodontal therapy alone, and interdental tooth cleaners remove more dental plaque (leading to reduced gingival inflammation) effectively than brushing alone. Therefore, in this study, standard periodontal therapy, scaling and root planning (SRP) will be provided alone, or SRP plus supportive periodontal therapy (SPT), the use of chlorhexidine gluconate rinse (Paroex®) and a rubber interdental bristle cleaner (Soft-Picks), to diabetics and non-diabetics with periodontal disease to determine the differences in response between the groups.

The main aim of this study is to evaluate the effects of SRP alone versus SRP+SPT on clinical, microbiological and immunological status of subjects with and without type 2 diabetes and with periodontal disease. A clearer understanding of how periodontal therapy affects diabetes status could lead to the development of novel new targeted therapies of both periodontal disease and diabetes.

Conditions: Diabetes Mellitus, Type II, Periodontitis
Being tested: Chlorhexidine gluconate oral rinse, Scaling & Root Planing, Soft Picks
Medical subject headings: Diabetes Mellitus, Type 2, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chlorhexidine gluconate oral rinseDrug
Also called Paroex
Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling & Root PlaningProcedure or surgery
Also called SRP
SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft PicksDevice
Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.

Study groups in NCT04830969
Study group	Role	What they receive
A: Diabetic + SRP + SPT	Experimental	The first group, A, includes diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks. Receives: Drug: Chlorhexidine gluconate oral rinse; Procedure: Scaling & Root Planing; Device: Soft Picks
B: Non-Diabetic + SRP + SPT	Experimental	The second group, B, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks. Receives: Drug: Chlorhexidine gluconate oral rinse; Procedure: Scaling & Root Planing; Device: Soft Picks
C: Diabetic + SRP	Active comparator	The third group, C, includes diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP). Receives: Procedure: Scaling & Root Planing
D: Non-Diabetic + SRP	Active comparator	The second group, D, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP). Receives: Procedure: Scaling & Root Planing

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline
Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured
Measured: Baseline to 6 months

Secondary outcomes (18)

Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline
Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured
Measured: Baseline to 3 months
Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline
The distance from the Cemento-enamel Junction (CEJ) to the free gingival margin is measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive.
Measured: Baseline to 3 months;Baseline to 6 months
Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline
The analysis is based on the measures of each participant. Participant instead of site is used as unite for arm/group. The measure, % sites with probing pocket depth >= 4 mm within each participant, indicates the portion of deep pocket in a participant. Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; The percentage of sites with Periodontal PD >= 4 mm within each participant was compared between measured time points.
Measured: Baseline to 3 months; Baseline to 6 months
Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline
The analysis is based on the measures of each participant. 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing per participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index per participant is compared between time points measured.
Measured: Baseline to 3 months; Baseline to 6 months
Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline
The analysis is based on the measures of each participant. Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth are evaluated. The Plaque Index (PI) of each participant is defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. The PI of each participant is assessed and compared between measured time points.
Measured: Baseline to 3 months; Baseline to 6 months
Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics
Probing depth (PD) or probing pocket depth (PPD), measured on six surfaces/tooth, is the distance in millimeters (mm) from the gingival margin to the base of the gingival pocket
Measured: Baseline to 3 months; Baseline to 6 months
Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
The distance from the Cemento-enamel Junction (CEJ) to the free gingival margin is measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive.
Measured: Baseline to 3 months; Baseline to 6 months
Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics
The analysis is based on the measure of each participant. Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; The percentage of sites with Periodontal PD >= 4 mm per participant is compared between measured time points.
Measured: Baseline to 3 months; Baseline to 6 months
Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
The analysis is based on the measures of each participant. 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing per participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index per participant is compared between time points measured.
Measured: Baseline to 3 months; Baseline to 6 months
Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
The analysis is based on the measures of each participant. Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth are evaluated. The Plaque Index (PI) of each participant is defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. The PI of each participant is assessed and compared between measured time points.
Measured: Baseline to 3 months; Baseline to 6 months
Changes in Hemoglobin A1c at 6 Months After Treatment
Hemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes.
Measured: Baseline to 6 months
Changes in Fasting Blood Glucose at 6 Months After Treatment
Fasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes.
Measured: Baseline to 6 months
Change in High Sensitivity C-reactive Protein at 6 Months After Treatment
The high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause
Measured: Baseline to 6 months
Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics
Hemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes.
Measured: Baseline to 6 months
Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics
Fasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes.
Measured: Baseline to 6 months
Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics
The high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause
Measured: Baseline to 6 months
Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months
Shannon index represents mean species diversity in a site at a local scale. Shannon index quantifies the uncertainty in predicting the species identity of an individual that is taken at random from the dataset. The minimum value is 0 and there is no maximum value. High values mean high species diversities.
Measured: Baseline; 6 Months
Change in Distance to the Healthy Plane Based on the Subgingival Plaque Microbiome at 6 Months
Analysis of microbiome community changes using the healthy plane (HP) as a reference. A healthy plane was calculated by fitting a plane that minimizes the sum of squares of distances from HC samples to the nearest point on the plane. The distance of each sample to the HP was then calculated. Higher values of distance to HP mean microbiome community changes towards disease status
Measured: Baseline to 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 201628 Jan 2021

First posted5 Apr 2021
Study start8 Nov 2016
Primary completion28 Jan 2021
Study completion28 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04830969
Sponsor's protocol ID: STUDY00000962
Acronym: DMRCT
Status last verified: Jan 2023
First submitted: 31 Mar 2021
Last updated: 1 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Nelson RG, Shlossman M, Budding LM, Pettitt DJ, Saad MF, Genco RJ, Knowler WC. Periodontal disease and NIDDM in Pima Indians. Diabetes Care. 1990 Aug;13(8):836-40. doi: 10.2337/diacare.13.8.836.
PubMed 2209317
Taylor GW, Burt BA, Becker MP, Genco RJ, Shlossman M, Knowler WC, Pettitt DJ. Non-insulin dependent diabetes mellitus and alveolar bone loss progression over 2 years. J Periodontol. 1998 Jan;69(1):76-83. doi: 10.1902/jop.1998.69.1.76.
PubMed 9527565
Arora N, Papapanou PN, Rosenbaum M, Jacobs DR Jr, Desvarieux M, Demmer RT. Periodontal infection, impaired fasting glucose and impaired glucose tolerance: results from the Continuous National Health and Nutrition Examination Survey 2009-2010. J Clin Periodontol. 2014 Jul;41(7):643-52. doi: 10.1111/jcpe.12258. Epub 2014 May 25.
PubMed 24708451
Engebretson S, Kocher T. Evidence that periodontal treatment improves diabetes outcomes: a systematic review and meta-analysis. J Periodontol. 2013 Apr;84(4 Suppl):S153-69. doi: 10.1902/jop.2013.1340017.
PubMed 23631575
Sgolastra F, Severino M, Pietropaoli D, Gatto R, Monaco A. Effectiveness of periodontal treatment to improve metabolic control in patients with chronic periodontitis and type 2 diabetes: a meta-analysis of randomized clinical trials. J Periodontol. 2013 Jul;84(7):958-73. doi: 10.1902/jop.2012.120377. Epub 2012 Oct 29.
PubMed 23106512
Engebretson SP, Hyman LG, Michalowicz BS, Schoenfeld ER, Gelato MC, Hou W, Seaquist ER, Reddy MS, Lewis CE, Oates TW, Tripathy D, Katancik JA, Orlander PR, Paquette DW, Hanson NQ, Tsai MY. The effect of nonsurgical periodontal therapy on hemoglobin A1c levels in persons with type 2 diabetes and chronic periodontitis: a randomized clinical trial. JAMA. 2013 Dec 18;310(23):2523-32. doi: 10.1001/jama.2013.282431.
PubMed 24346989
Borgnakke WS, Chapple IL, Genco RJ, Armitage G, Bartold PM, D'Aiuto F, Eke PI, Giannobile WV, Kocher T, Kornman KS, Lang NP, Madianos PN, Murakami S, Nishimura F, Offenbacher S, Preshaw PM, Rahman AU, Sanz M, Slots J, Tonetti MS, Van Dyke TE. The multi-center randomized controlled trial (RCT) published by the journal of the American Medical Association (JAMA) on the effect of periodontal therapy on glycated hemoglobin (HbA1c) has fundamental problems. J Evid Based Dent Pract. 2014 Sep;14(3):127-32. doi: 10.1016/j.jebdp.2014.04.017. Epub 2014 May 21.
PubMed 25234213
Colombo AP, Boches SK, Cotton SL, Goodson JM, Kent R, Haffajee AD, Socransky SS, Hasturk H, Van Dyke TE, Dewhirst F, Paster BJ. Comparisons of subgingival microbial profiles of refractory periodontitis, severe periodontitis, and periodontal health using the human oral microbe identification microarray. J Periodontol. 2009 Sep;80(9):1421-32. doi: 10.1902/jop.2009.090185.
PubMed 19722792
Colombo AP, Bennet S, Cotton SL, Goodson JM, Kent R, Haffajee AD, Socransky SS, Hasturk H, Van Dyke TE, Dewhirst FE, Paster BJ. Impact of periodontal therapy on the subgingival microbiota of severe periodontitis: comparison between good responders and individuals with refractory periodontitis using the human oral microbe identification microarray. J Periodontol. 2012 Oct;83(10):1279-87. doi: 10.1902/jop.2012.110566. Epub 2012 Feb 10.
PubMed 22324467
Kirst ME, Li EC, Alfant B, Chi YY, Walker C, Magnusson I, Wang GP. Dysbiosis and alterations in predicted functions of the subgingival microbiome in chronic periodontitis. Appl Environ Microbiol. 2015 Jan;81(2):783-93. doi: 10.1128/AEM.02712-14. Epub 2014 Nov 14.
PubMed 25398868
Wang J, Qi J, Zhao H, He S, Zhang Y, Wei S, Zhao F. Metagenomic sequencing reveals microbiota and its functional potential associated with periodontal disease. Sci Rep. 2013;3:1843. doi: 10.1038/srep01843.
PubMed 23673380
Perez-Chaparro PJ, Goncalves C, Figueiredo LC, Faveri M, Lobao E, Tamashiro N, Duarte P, Feres M. Newly identified pathogens associated with periodontitis: a systematic review. J Dent Res. 2014 Sep;93(9):846-58. doi: 10.1177/0022034514542468. Epub 2014 Jul 29.
PubMed 25074492
Beiswanger BB, Mallat ME, Jackson RD, Mau MS, Farah CF, Bosma ML, Bollmer BW, Hancock EB. Clinical effects of a 0.12% chlorhexidine rinse as an adjunct to scaling and root planing. J Clin Dent. 1992;3(2):33-8.
PubMed 1524682
Faveri M, Gursky LC, Feres M, Shibli JA, Salvador SL, de Figueiredo LC. Scaling and root planing and chlorhexidine mouthrinses in the treatment of chronic periodontitis: a randomized, placebo-controlled clinical trial. J Clin Periodontol. 2006 Nov;33(11):819-28. doi: 10.1111/j.1600-051X.2006.00994.x. Epub 2006 Sep 11.
PubMed 16965522
Abouassi T, Woelber JP, Holst K, Stampf S, Doerfer CE, Hellwig E, Ratka-Kruger P. Clinical efficacy and patients' acceptance of a rubber interdental bristle. A randomized controlled trial. Clin Oral Investig. 2014 Sep;18(7):1873-80. doi: 10.1007/s00784-013-1164-3. Epub 2014 Jan 10.
PubMed 24407549

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Periodontal Therapy on Patients With Diabetes: A Pilot Study
ClinicalTrials.gov ID: NCT04830969
Acronym / sponsor ID: DMRCT / STUDY00000962
Conditions: Diabetes Mellitus, Type II, Periodontitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: State University of New York at BuffaloUniversity, hospital or other
Collaborators: Sunstar, Inc.
Study start: 8 Nov 2016 (actual)
Primary completion: 28 Jan 2021 (actual)
Study completion: 28 Jan 2021 (actual)
First posted: 5 Apr 2021 (actual)
Results: Posted 1 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Scaling and root planning (SRP) alone, or
SRP and supportive periodontal therapy (SPT), the use of chlorhexidine gluconate rinse (Paroex®) and a rubber interdental bristle cleaner (Soft-Picks) The main goal of this clinical trial is to evaluate the effects of SRP alone versus SRP+SPT on clinical, microbiological and immunological status in participants. A clearer understanding of how periodontal therapy affects diabetes status could lead to the development of new therapies for periodontal disease and diabetes.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
A: Diabetic + SRP + SPT	Experimental	Drug: Chlorhexidine gluconate oral rinse, Procedure: Scaling & Root Planing, Device: Soft PicksThe first group, A, includes diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
B: Non-Diabetic + SRP + SPT	Experimental	Drug: Chlorhexidine gluconate oral rinse, Procedure: Scaling & Root Planing, Device: Soft PicksThe second group, B, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
C: Diabetic + SRP	Active comparator	Procedure: Scaling & Root PlaningThe third group, C, includes diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
D: Non-Diabetic + SRP	Active comparator	Procedure: Scaling & Root PlaningThe second group, D, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).

Who may qualify

Ages: 25 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Be able to understand the informed consent form and be willing and able to read and sign it.
At least 25 years of age.
Be able to understand and follow directions for study procedures.
At least 14 natural teeth, not counting third molars ("wisdom teeth").
At least 2 interproximal sites with CAL >= 4 mm or at least 2 interproximal sites with PD >= 5 mm.

Key exclusion criteria (13 listed)

Presence of orthodontic appliances ("braces").
An abnormal condition of lips, lining of the mouth, tongue, or gums (except for periodontal disease). If subject has a cold sore, canker sore, or injury in their mouth, they may return after the sore or injury heals.
Abscess of the gingiva caused by periodontal disease, or visible gross tooth decay
A broken tooth root or an abscessed tooth. Subject may be allowed to participate in the study after the condition is successfully treated.
Periodontal treatment or antibiotic therapy in the past 6 months.

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
Chlorhexidine gluconate oral rinseAlso: ParoexParoex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.	Drug	A: Diabetic + SRP + SPT, B: Non-Diabetic + SRP + SPT
Scaling & Root PlaningAlso: SRPSRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.	Procedure or surgery	A: Diabetic + SRP + SPT, B: Non-Diabetic + SRP + SPT, C: Diabetic + SRP, D: Non-Diabetic + SRP
Soft PicksSoft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.	Device	A: Diabetic + SRP + SPT, B: Non-Diabetic + SRP + SPT

Primary outcome

Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline
Time frame: Baseline to 6 months
Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured

18 secondary outcomes

Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline
Time frame: Baseline to 3 months
Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline
Time frame: Baseline to 3 months;Baseline to 6 months
Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline
Time frame: Baseline to 3 months; Baseline to 6 months
Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline
Time frame: Baseline to 3 months; Baseline to 6 months
Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline
Time frame: Baseline to 3 months; Baseline to 6 months
Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics
Time frame: Baseline to 3 months; Baseline to 6 months
Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
Time frame: Baseline to 3 months; Baseline to 6 months
Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics
Time frame: Baseline to 3 months; Baseline to 6 months
Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
Time frame: Baseline to 3 months; Baseline to 6 months
Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
Time frame: Baseline to 3 months; Baseline to 6 months
Changes in Hemoglobin A1c at 6 Months After Treatment
Time frame: Baseline to 6 months
Changes in Fasting Blood Glucose at 6 Months After Treatment
Time frame: Baseline to 6 months
Change in High Sensitivity C-reactive Protein at 6 Months After Treatment
Time frame: Baseline to 6 months
Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics
Time frame: Baseline to 6 months
Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics
Time frame: Baseline to 6 months
Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics
Time frame: Baseline to 6 months
Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months
Time frame: Baseline; 6 Months
Change in Distance to the Healthy Plane Based on the Subgingival Plaque Microbiome at 6 Months
Time frame: Baseline to 6 Months

Results and safety

Results posted to the registry on 1 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A: SRP + SPT	58	45
B: SRP	56	41

Primary outcome: Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline

Time frame: Baseline to 6 months. Mean (Standard Deviation). Unit: mm

Measure	Group A: SRP + SPT n = 45	Group B: SRP n = 41
Value	-0.25 (0.24)	-0.18 (0.2)

Group A: SRP + SPT vs Group B: SRP: p = 0.16, t-test, 2 sided

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 Months After Treatment at Baseline. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diabetic + SRP + SPT	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Diabetic + SRP	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Non-Diabetic + SRP + SPT	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Non-Diabetic + SRP	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 2209317Nelson RG, Shlossman M, Budding LM, Pettitt DJ, Saad MF, Genco RJ, Knowler WC. Periodontal disease and NIDDM in Pima Indians. Diabetes Care. 1990 Aug;13(8):836-40. doi: 10.2337/diacare.13.8.836.
Background: PubMed 9527565Taylor GW, Burt BA, Becker MP, Genco RJ, Shlossman M, Knowler WC, Pettitt DJ. Non-insulin dependent diabetes mellitus and alveolar bone loss progression over 2 years. J Periodontol. 1998 Jan;69(1):76-83. doi: 10.1902/jop.1998.69.1.76.
Background: PubMed 24708451Arora N, Papapanou PN, Rosenbaum M, Jacobs DR Jr, Desvarieux M, Demmer RT. Periodontal infection, impaired fasting glucose and impaired glucose tolerance: results from the Continuous National Health and Nutrition Examination Survey 2009-2010. J Clin Periodontol. 2014 Jul;41(7):643-52. doi: 10.1111/jcpe.12258. Epub 2014 May 25.
Background: PubMed 23631575Engebretson S, Kocher T. Evidence that periodontal treatment improves diabetes outcomes: a systematic review and meta-analysis. J Periodontol. 2013 Apr;84(4 Suppl):S153-69. doi: 10.1902/jop.2013.1340017.
Background: PubMed 23106512Sgolastra F, Severino M, Pietropaoli D, Gatto R, Monaco A. Effectiveness of periodontal treatment to improve metabolic control in patients with chronic periodontitis and type 2 diabetes: a meta-analysis of randomized clinical trials. J Periodontol. 2013 Jul;84(7):958-73. doi: 10.1902/jop.2012.120377. Epub 2012 Oct 29.
Background: PubMed 24346989Engebretson SP, Hyman LG, Michalowicz BS, Schoenfeld ER, Gelato MC, Hou W, Seaquist ER, Reddy MS, Lewis CE, Oates TW, Tripathy D, Katancik JA, Orlander PR, Paquette DW, Hanson NQ, Tsai MY. The effect of nonsurgical periodontal therapy on hemoglobin A1c levels in persons with type 2 diabetes and chronic periodontitis: a randomized clinical trial. JAMA. 2013 Dec 18;310(23):2523-32. doi: 10.1001/jama.2013.282431.
Background: PubMed 25234213Borgnakke WS, Chapple IL, Genco RJ, Armitage G, Bartold PM, D'Aiuto F, Eke PI, Giannobile WV, Kocher T, Kornman KS, Lang NP, Madianos PN, Murakami S, Nishimura F, Offenbacher S, Preshaw PM, Rahman AU, Sanz M, Slots J, Tonetti MS, Van Dyke TE. The multi-center randomized controlled trial (RCT) published by the journal of the American Medical Association (JAMA) on the effect of periodontal therapy on glycated hemoglobin (HbA1c) has fundamental problems. J Evid Based Dent Pract. 2014 Sep;14(3):127-32. doi: 10.1016/j.jebdp.2014.04.017. Epub 2014 May 21.
Background: PubMed 19722792Colombo AP, Boches SK, Cotton SL, Goodson JM, Kent R, Haffajee AD, Socransky SS, Hasturk H, Van Dyke TE, Dewhirst F, Paster BJ. Comparisons of subgingival microbial profiles of refractory periodontitis, severe periodontitis, and periodontal health using the human oral microbe identification microarray. J Periodontol. 2009 Sep;80(9):1421-32. doi: 10.1902/jop.2009.090185.
Background: PubMed 22324467Colombo AP, Bennet S, Cotton SL, Goodson JM, Kent R, Haffajee AD, Socransky SS, Hasturk H, Van Dyke TE, Dewhirst FE, Paster BJ. Impact of periodontal therapy on the subgingival microbiota of severe periodontitis: comparison between good responders and individuals with refractory periodontitis using the human oral microbe identification microarray. J Periodontol. 2012 Oct;83(10):1279-87. doi: 10.1902/jop.2012.110566. Epub 2012 Feb 10.
Background: PubMed 25398868Kirst ME, Li EC, Alfant B, Chi YY, Walker C, Magnusson I, Wang GP. Dysbiosis and alterations in predicted functions of the subgingival microbiome in chronic periodontitis. Appl Environ Microbiol. 2015 Jan;81(2):783-93. doi: 10.1128/AEM.02712-14. Epub 2014 Nov 14.
Background: PubMed 23673380Wang J, Qi J, Zhao H, He S, Zhang Y, Wei S, Zhao F. Metagenomic sequencing reveals microbiota and its functional potential associated with periodontal disease. Sci Rep. 2013;3:1843. doi: 10.1038/srep01843.
Background: PubMed 25074492Perez-Chaparro PJ, Goncalves C, Figueiredo LC, Faveri M, Lobao E, Tamashiro N, Duarte P, Feres M. Newly identified pathogens associated with periodontitis: a systematic review. J Dent Res. 2014 Sep;93(9):846-58. doi: 10.1177/0022034514542468. Epub 2014 Jul 29.
Individual participant dataSharing planned: No

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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.

Robert E Schifferle, DDS, PhD principal investigator

University at Buffalo, State University of New York

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 13 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: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04830969, which also lists 17 linked publications.

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 1 Mar 2023.