Phase 2
N=114
Impact of Periodontal Therapy on Patients With Diabetes
Diabetes Mellitus, Type II · Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT04830969 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline — -0.25; -0.18 mm — p=0.16
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Chlorhexidine gluconate oral rinse (Drug); Scaling & Root Planing (Procedure); Soft Picks (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline |
-0.25; -0.18 | 0.16 |
| SECONDARY Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline |
-0.31; -0.21 | 0.08 |
| SECONDARY Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline |
-0.1; -0.2; -0.1; -0.12 | 0.14 |
| SECONDARY Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline |
-8.71; -4.74; -7.03; -4.73 | <0.01 sig |
| SECONDARY Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline |
-13.24; -5.57; -8.93; -4.09 | < 0.01 sig |
| SECONDARY Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline |
-14.76; -7.7; 9.68; -5.19 | < 0.01 sig |
| SECONDARY Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics |
-0.36; -0.17; -0.26; -0.27; -0.27; -0.12 | 0.01 sig |
| SECONDARY Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics |
-0.11; -0.17; -0.1; -0.23; -0.14; -0.06 | 0.44 |
| SECONDARY 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 |
-10.23; -4.22; -7.39; -5.4; -7.85; 4.12 | <0.01 sig |
| SECONDARY Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics |
-13.45; -4.35; -13.06; -7.13; -9.62; -1.95 | 0.01 sig |
| SECONDARY Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics |
-17.46; -7.67; -12.4; -7.75; -12.11; -4.97 | 0.02 sig |
| SECONDARY Changes in Hemoglobin A1c at 6 Months After Treatment |
-0.01; 0.14 | 0.27 |
| SECONDARY Changes in Fasting Blood Glucose at 6 Months After Treatment |
-2.13; 1.85 | 0.54 |
| SECONDARY Change in High Sensitivity C-reactive Protein at 6 Months After Treatment |
-0.33; -1.25 | 0.12 |
| SECONDARY Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics |
-0.04; 0.30; 0.01; -0.07 | 0.20 |
| SECONDARY Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics |
-5.05; 2.74; 0.42; 0.72 | 0.58 |
| SECONDARY Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics |
0.23; -2.23; -0.41; 0.01 | 0.46 |
| SECONDARY Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months |
5.31; 5.27; 5.2; 5.34 | 0.7 |
| SECONDARY Change in Distance to the Healthy Plane Based on the Subgingival Plaque Microbiome at 6 Months |
-2.16; -1.26 | 0.53 |
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. Scaling and root planning (SRP) alone, or
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04830969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.