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Chronic PeriodontitisrePAIRNCT03241511

Novel PAradigm to Improve Inflammatory Burden in ESRD (rePAIR): A Pilot and Feasibility Randomized Controlled Trial

A study testing Test in people with Chronic Periodontitis and End Stage Renal Disease, run by UConn Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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: 1) ongoing and repeated gum disease therapy including deep tooth cleaning followed by multiple appointments of maintenance 2)… Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Test
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
7 Nov 2017to 1 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must be referred by nephrologist
  • Patient must be diagnosed with ESRD and on Hemodialysis
  • life expectancy more than one year
  • at least 21 years of age
  • 12 or more teeth
  • must meet the Periodontal diagnosis criteria (The diagnosis of periodontitis is based on the definition of moderate periodontitis with at least 2 sites with CAL≥4mm or at least 2 sites with PD≥5mm not on the same tooth (Page and Eke 2007).)

Who cannot join

  • Anticipating a kidney transplant
  • AIDS
  • Active malignancy
  • Poor adherence to hemodialysis
  • Dementia
  • Currently prescribed anti-inflammatory medication
  • Temporary catheter for dialysis access
  • Gum disease treatment within the last year

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030-1710

Other trials in United States

About this study

Official title: Pilot and Feasibility Clinical Research Grants in Kidney or Urologic Diseases (R21)

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:

  • 1) ongoing and repeated gum disease therapy including deep tooth cleaning followed by multiple appointments of maintenance
  • 2) single session of gum disease therapy with only one session of deep tooth cleaning Samples of blood will be obtained for study to examine the changes of inflammatory substances in the blood as a result of the two different gum disease treatments. Also, a 14-question survey will be discussed with you to assess oral health related quality of life (OHIP-14) and the way it is affected by oral care.
Read more

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.

Being tested
Test
Keywords
Periodontitis, End Stage Renal Disease, Periodontal treatment
Medical subject headings
Chronic Periodontitis, Kidney Failure, Chronic, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TestOther

    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).

Study groups in NCT03241511
Study groupRoleWhat they receive
TestExperimentalBriefly, 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.
Receives: Other: Test
ControlNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum CRP

    Inflammatory markers

    Measured: 6 months

Secondary outcomes (6)

  1. Probing depth PD

    Clinical periodontal outcome

    Measured: 6 months

  2. Clinical attachment levels CAL

    Clinical periodontal outcome

    Measured: 6 months

  3. OHIP-14

    Patient Centered Outcome

    Measured: 6 months

  4. Serum IL-6

    Inflammatory Marker

    Measured: 6 months

  5. F2 isoprostanes

    Oxidative Stress Marker

    Measured: 6 months

  6. isofurans

    Oxidative Stress Marker

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2017
  2. Study start7 Nov 2017
  3. Primary completion1 Dec 2020
  4. Study completion1 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03241511
Sponsor's protocol ID
16-111-1
Other IDs
R21DK108076
Acronym
rePAIR
Status last verified
Jun 2025
First submitted
2 Aug 2017
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 29996883

Questions about this trial

What is this clinical trial studying?

A study testing Test in people with Chronic Periodontitis and End Stage Renal Disease, run by UConn Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum CRP (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03241511, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.

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