Impact of Periodontal Therapy on Patients With Diabetes

NCT04830969 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STUDY00000962
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.Scaling and root planning (SRP) alone, or
2. 2.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.

Conditions

Diabetes Mellitus, Type II; Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to 6 months

Secondary Outcomes (18)

• Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline

  Baseline to 3 months

• Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline

  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

  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

  Baseline to 3 months; Baseline to 6 months

• Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline

  Baseline to 3 months; Baseline to 6 months

Study Arms (4)

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.

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.

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).

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).

Procedure: Scaling & Root Planing

Interventions

Chlorhexidine gluconate oral rinse DRUG

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.

Also known as: Paroex

A: Diabetic + SRP + SPT; B: Non-Diabetic + SRP + SPT

Scaling & Root Planing PROCEDURE

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.

Also known as: SRP

A: Diabetic + SRP + SPT; B: Non-Diabetic + SRP + SPT; C: Diabetic + SRP; D: Non-Diabetic + SRP

Soft Picks DEVICE

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.

A: Diabetic + SRP + SPT; B: Non-Diabetic + SRP + SPT

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Sunstar, Inc.: collaborator

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

Related Publications (17)

• 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.

  PMID: 2209317 BACKGROUND

• 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.

  PMID: 9527565 BACKGROUND

• 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.

  PMID: 24708451 BACKGROUND

• 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.

  PMID: 23631575 BACKGROUND

• 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.

  PMID: 23106512 BACKGROUND

• 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.

  PMID: 24346989 BACKGROUND

• 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.

  PMID: 25234213 BACKGROUND

• 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.

  PMID: 19722792 BACKGROUND

• 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.

  PMID: 22324467 BACKGROUND

• 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.

  PMID: 25398868 BACKGROUND

• 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.

  PMID: 23673380 BACKGROUND

• 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.

  PMID: 25074492 BACKGROUND

• 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.

  PMID: 1524682 BACKGROUND

• 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.

  PMID: 16965522 BACKGROUND

• 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.

  PMID: 24407549 BACKGROUND

• Santos VR, Lima JA, Miranda TS, Goncalves TE, Figueiredo LC, Faveri M, Duarte PM. Full-mouth disinfection as a therapeutic protocol for type-2 diabetic subjects with chronic periodontitis: twelve-month clinical outcomes: a randomized controlled clinical trial. J Clin Periodontol. 2013 Feb;40(2):155-62. doi: 10.1111/jcpe.12040.

  PMID: 23305133 BACKGROUND

• Li L, Hayashi-Okada Y, Falkner KL, Cervi S, Andrusz S, Shimizu Y, Zambon JJ, Kirkwood KL, Schifferle RE, Diaz PI. Randomized Trial to Test a Chemo-Mechanical Antiplaque Regimen as Adjunct to Periodontal Therapy. JDR Clin Trans Res. 2024 Apr;9(2):160-169. doi: 10.1177/23800844231167065. Epub 2023 May 6.

  PMID: 37148266 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Periodontitis

Interventions

Chlorhexidine; Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Results Point of Contact

• Title: Lu Li
• Organization: University at Buffalo

lli59@buffalo.edu

7168296284

Study Officials

• Robert E Schifferle, DDS, PhD

  University at Buffalo, State University of New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 5, 2021
• Study Start: November 8, 2016
• Primary Completion: January 28, 2021
• Study Completion: January 28, 2021
• Last Updated: March 1, 2023
• Results First Posted: March 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)