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| ID | Type | Description | Link |
|---|---|---|---|
| R21DK108076 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this project is to assess repeated and ongoing oral care and the way it may affect inflammation and quality of life in hemodialysis patients. Two treatment groups will be compared:
For this project, four dialysis centers will be randomly assigned to either of the treatment groups #1 or #2 prior to your enrollment. For this purpose, there are two distinct consent forms explaining the visits, procedures and risks of the two treatment groups #1 or #2. As a result, all participants in the same dialysis center will belong to the same treatment group (either #1 or #2) and presented with the corresponding consent form.
This dialysis center has been randomized to treatment group # 1; therefore you will receive ongoing and repeated gum disease therapy including deep tooth cleaning followed by multiple appointments of maintenance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Briefly, treatment sessions will include oral hygiene behavioral modification and scaling and root planning (removing the bacterial biofilm and calculus below the gum line) in order to eliminate etiologic factors and control periodontal inflammation. Once the treatment sessions are completed, the patients will enter the maintenance phase and will be followed for 6 months. In this phase, the patients will receive systematic and repeated supportive periodontal treatment (tooth cleanings above the gum line with re-enforcement of oral hygiene). Outcomes will be assessed at 2-, 4-, and 6-months. Throughout the course of the study, additional dental needs will be addressed with immediate referral to the subject's general dentist or clinics at the University of Connecticut. |
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| Control | No Intervention | The Control arm will receive only a single treatment session without maintenance sessions (see visit Table in Human Subject Protection section). Outcomes will be assessed at 2-, 4-, and 6-months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test | Other | Briefly, treatment sessions will include oral hygiene behavioral modification and scaling and root planning (removing the bacterial biofilm and calculus below the gum line) in order to eliminate etiologic factors and control periodontal inflammation. Once the treatment sessions are completed, the patients will enter the maintenance phase and will be followed for 6 months. In this phase, the patients will receive systematic supportive periodontal treatment (tooth cleanings above the gum line with re-enforcement of oral hygiene). |
| Measure | Description | Time Frame |
|---|---|---|
| Serum CRP | Inflammatory markers | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Probing depth PD | Clinical periodontal outcome | 6 months |
| Clinical attachment levels CAL | Clinical periodontal outcome | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Effie Ioannidou, DDS, MS | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06030-1710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29996883 | Background | Trivedi R, Fares G, Nunez VB, Campbell R, Clement M, Burleson J, Himmelfarb J, Ioannidou E. Novel PAradigm to improve Inflammatory burden in end stage Renal disease (rePAIR): study protocol for a randomized controlled trial. Trials. 2018 Jul 11;19(1):370. doi: 10.1186/s13063-018-2760-y. |
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Once the study is completed, the data will be available without cost to researchers. As part of the registration process, users must agree to the conditions of use governing access to the public release data (e.g., data destruction after analyses are complete, proper acknowledgement of data resources). Data will be provided at no cost and all data will be de-identified prior to sharing.
The data will available after the completion of the study
As part of the registration process, users must agree to the conditions of use governing access to the public release data (e.g., data destruction after analyses are complete, proper acknowledgement of data resources). Data will be provided at no cost and all data will be de-identified prior to sharing.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2018 | Sep 21, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| D007676 | Kidney Failure, Chronic |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
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|
| OHIP-14 | Patient Centered Outcome | 6 months |
| Serum IL-6 | Inflammatory Marker | 6 months |
| F2 isoprostanes | Oxidative Stress Marker | 6 months |
| isofurans | Oxidative Stress Marker | 6 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |