Trial · NCT04830969
Impact of Periodontal Therapy on Patients With Diabetes
NCT04830969, Phase 2, Completed, State University of New York at Buffalo; results first posted 2023-03-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Impact of Periodontal Therapy on Patients With Diabetes. Trials, record NCT04830969. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04830969
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of Periodontal Therapy on Patients With Diabetes
- NCT number
- NCT04830969
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 116 participants, actual
- Lead sponsor
- State University of New York at Buffalo
- Conditions
- Diabetes Mellitus, Type II, Periodontitis
- Interventions
- Chlorhexidine gluconate oral rinse, Scaling & Root Planing, Soft Picks
- First posted
- 2021-04-05
- Last updated
- 2023-03-01
- Results first posted
- 2023-03-01
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline | 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 |
| Secondary | Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline | 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 |
| Secondary | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline | 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. |
| Secondary | Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics | 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 |
| Secondary | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | 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. |
| 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 | 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. |
| Secondary | Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | 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. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline | Baseline to 6 months | mm | MEAN | |
| SECONDARY | Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline | Baseline to 3 months | mm | MEAN | |
| SECONDARY | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline | Baseline to 3 months;Baseline to 6 months | mm | MEAN | |
| SECONDARY | 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 | For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants. | % sites with PD >= 4 mm of a participant | MEAN |
| SECONDARY | 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 | For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants. | BOP index of a participant | MEAN |
| SECONDARY | Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline | Baseline to 3 months; Baseline to 6 months | For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants. | Plaque Index of a participant | MEAN |
| SECONDARY | Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics | Baseline to 3 months; Baseline to 6 months | mm | MEAN | |
| SECONDARY | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months; Baseline to 6 months | mm | MEAN | |
| 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 | Baseline to 3 months; Baseline to 6 months | For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants. | % sites with PD >= 4 mm of a participant | MEAN |
| SECONDARY | Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months; Baseline to 6 months | For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants. | BOP index of a participant | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline | Group A: SRP + SPT | -0.25 | Standard Deviation 0.24 | mm | |
| Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline | Group B: SRP | -0.18 | Standard Deviation 0.2 | mm | |
| Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline | Group A: SRP + SPT | -0.31 | Standard Deviation 0.27 | mm | |
| Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline | Group B: SRP | -0.21 | Standard Deviation 0.22 | mm | |
| Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline | Group A: SRP + SPT | Baseline to 3-month | -0.1 | Standard Deviation 0.29 | mm |
| Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline | Group B: SRP | Baseline to 3-month | -0.2 | Standard Deviation 0.29 | mm |
| Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline | Group A: SRP + SPT | Baseline to 6-month | -0.1 | Standard Deviation 0.25 | mm |
| Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline | Group B: SRP | Baseline to 6-month | -0.12 | Standard Deviation 0.27 | mm |
| Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline | Group A: SRP + SPT | Baseline to 3-month | -8.71 | Standard Deviation 7.03 | % sites with PD >= 4 mm of a participant |
| Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline | Group B: SRP | Baseline to 3-month | -4.74 | Standard Deviation 5.1 | % sites with PD >= 4 mm of a participant |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A: SRP + SPT | 58 | |
| Overall Study | STARTED | B: SRP | 56 | |
| Overall Study | COMPLETED | A: SRP + SPT | 45 | |
| Overall Study | COMPLETED | B: SRP | 41 | |
| Overall Study | NOT COMPLETED | A: SRP + SPT | 13 | |
| Overall Study | NOT COMPLETED | B: SRP | 15 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Diabetic + SRP + SPT | 0 | 21 |
| Total, all-cause mortality | Diabetic + SRP | 0 | 23 |
| Total, all-cause mortality | Non-Diabetic + SRP + SPT | 0 | 24 |
| Total, all-cause mortality | Non-Diabetic + SRP | 0 | 18 |
| Total, other adverse events | Diabetic + SRP + SPT | 0 | 21 |
| Total, other adverse events | Diabetic + SRP | 0 | 23 |
| Total, other adverse events | Non-Diabetic + SRP + SPT | 0 | 24 |
| Total, other adverse events | Non-Diabetic + SRP | 0 | 18 |
| Total, serious adverse events | Diabetic + SRP + SPT | 0 | 21 |
| Total, serious adverse events | Diabetic + SRP | 0 | 23 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers17
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04830969
GET https://conductscience.org/api/trials/v1/NCT04830969/results?page=2