NCT04830969: DMRCT

Impact of Periodontal Therapy on Patients With Diabetes

Completed Phase 2 Results posted Last updated 1 March 2023

What this trial tests

Phase 2 trial testing Chlorhexidine gluconate oral rinse in Diabetes Mellitus, Type II in 116 participants. Completed in 28 January 2021.

Timeline

8 November 2016

Primary endpoint
28 January 2021

28 January 2021

Quick facts

Lead sponsor	State University of New York at Buffalo
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	116
Start date	8 November 2016
Primary completion	28 January 2021
Estimated completion	28 January 2021
Sites	1 location across United States

Drugs / interventions tested

• Chlorhexidine gluconate oral rinse
• Scaling & Root Planing
• Soft Picks

Conditions studied

• Diabetes Mellitus, Type II — all drugs for Diabetes Mellitus, Type II →
• Periodontitis — all drugs for Periodontitis →

Sponsor

State University of New York at Buffalo

Who can join

25 and older, any sex, with Diabetes Mellitus, Type II or Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Group A: SRP + SPT	-0.25	± 0.24
Group B: SRP	-0.18	± 0.2

Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline Secondary · Baseline to 3 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

Group	Value	95% CI
Group A: SRP + SPT	-0.31	± 0.27
Group B: SRP	-0.21	± 0.22

Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline Secondary · Baseline to 3 months;Baseline to 6 months

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.

Baseline to 3-month

Group	Value	95% CI
Group A: SRP + SPT	-0.1	± 0.29
Group B: SRP	-0.2	± 0.29

Baseline to 6-month

Group	Value	95% CI
Group A: SRP + SPT	-0.1	± 0.25
Group B: SRP	-0.12	± 0.27

Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline Secondary · Baseline to 3 months; Baseline to 6 months

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.

Baseline to 3-month

Group	Value	95% CI
Group A: SRP + SPT	-8.71	± 7.03
Group B: SRP	-4.74	± 5.1

Baseline to 6-month

Group	Value	95% CI
Group A: SRP + SPT	-7.03	± 6.72
Group B: SRP	-4.73	± 5.35

Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline Secondary · Baseline to 3 months; Baseline to 6 months

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.

Baseline to 3 months

Group	Value	95% CI
Group A: SRP + SPT	-13.24	± 9.69
Group B: SRP	-5.57	± 10.1

Baseline to 6 months

Group	Value	95% CI
Group A: SRP + SPT	-8.93	± 10.76
Group B: SRP	-4.09	± 9.22

Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline Secondary · Baseline to 3 months; Baseline to 6 months

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.

Baseline to 3 months

Group	Value	95% CI
Group A: SRP + SPT	-14.76	± 11.52
Group B: SRP	-7.7	± 12.5

Baseline to 6 months

Group	Value	95% CI
Group A: SRP + SPT	9.68	± 12.22
Group B: SRP	-5.19	± 12.08

Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics Secondary · Baseline to 3 months; Baseline to 6 months

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

Baseline to 3-month

Group	Value	95% CI
Diabetic + SRP + SPT	-0.36	± 0.29
Diabetic + SRP	-0.17	± 0.17
Non-Diabetic + SRP + SPT	-0.26	± 0.24
Non-Diabetic + SRP	-0.27	± 0.26

Baseline to 6-month

Group	Value	95% CI
Diabetic + SRP + SPT	-0.27	± 0.27
Diabetic + SRP	-0.12	± 0.19
Non-Diabetic + SRP + SPT	-0.24	± 0.21
Non-Diabetic + SRP	-0.26	± 0.19

Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics Secondary · Baseline to 3 months; Baseline to 6 months

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.

Baseline to 3 months

Group	Value	95% CI
Diabetic + SRP + SPT	-0.11	± 0.28
Diabetic + SRP	-0.17	± 0.25
Non-Diabetic + SRP + SPT	-0.1	± 0.31
Non-Diabetic + SRP	-0.23	± 0.33

Baseline to 6 months

Group	Value	95% CI
Diabetic + SRP + SPT	-0.14	± 0.24
Diabetic + SRP	-0.06	± 0.24
Non-Diabetic + SRP + SPT	-0.07	± 0.26
Non-Diabetic + SRP	-0.19	± 0.29

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 Secondary · Baseline to 3 months; Baseline to 6 months

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.

Baseline to 3-month

Group	Value	95% CI
Diabetic + SRP + SPT	-10.23	± 7.88
Diabetic + SRP	-4.22	± 4.22
Non-Diabetic + SRP + SPT	-7.39	± 6.05
Non-Diabetic + SRP	-5.4	± 6.12

Baseline to 6-month

Group	Value	95% CI
Diabetic + SRP + SPT	-7.85	± 8.02
Diabetic + SRP	4.12	± 5.55
Non-Diabetic + SRP + SPT	-6.3	± 5.41
Non-Diabetic + SRP	-5.52	± 5.13

Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics Secondary · Baseline to 3 months; Baseline to 6 months

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.

Baseline to 3 months

Group	Value	95% CI
Diabetic + SRP + SPT	-13.45	± 11.31
Diabetic + SRP	-4.35	± 10.62
Non-Diabetic + SRP + SPT	-13.06	± 8.27
Non-Diabetic + SRP	-7.13	± 9.45

Baseline to 6 months

Group	Value	95% CI
Diabetic + SRP + SPT	-9.62	± 13.34
Diabetic + SRP	-1.95	± 8.83
Non-Diabetic + SRP + SPT	-8.32	± 8.12
Non-Diabetic + SRP	-6.82	± 9.23

Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics Secondary · Baseline to 3 months; Baseline to 6 months

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.

Baseline to 3 months

Group	Value	95% CI
Diabetic + SRP + SPT	-17.46	± 13.19
Diabetic + SRP	-7.67	± 13.16
Non-Diabetic + SRP + SPT	-12.4	± 9.48
Non-Diabetic + SRP	-7.75	± 11.99

Baseline to 6 months

Group	Value	95% CI
Diabetic + SRP + SPT	-12.11	± 14.05
Diabetic + SRP	-4.97	± 12.43
Non-Diabetic + SRP + SPT	-7.56	± 10.18
Non-Diabetic + SRP	-5.48	± 11.96

Changes in Hemoglobin A1c at 6 Months After Treatment Secondary · Baseline to 6 months

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.

Group	Value	95% CI
Group A: SRP + SPT	-0.01	± 0.55
Group B: SRP	0.14	± 0.72

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of nonsurgical periodontal treatment on patients with periodontitis and type 2 diabetes mellitus: a systematic review and Bayesian network meta-analysis.
   Xie X, Xu J, Li Y, Tang L, et al · · 2025 · cited 3× · PMID 40356262 · DOI 10.2340/aos.v84.43344
2. Randomized Trial to Test a Chemo-Mechanical Antiplaque Regimen as Adjunct to Periodontal Therapy.
   Li L, Hayashi-Okada Y, Falkner KL, Cervi S, et al · · 2024 · cited 3× · PMID 37148266 · DOI 10.1177/23800844231167065