Kidney and Periodontal Disease Study

NCT01802216 | Completed Results DMC

• 1 other identifier: A119016
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is (1) to determine whether a 12-month trial of patients from underserved communities with clinically significant gum disease and kidney disease randomly assigned to intensive gum disease treatment or delayed treatment is feasible and (2) to determine the variability of various tests of kidney function and inflammation in response to intensive gum disease treatment.

Conditions

Chronic Kidney Disease; Periodontal Disease

Keywords

chronic kidney disease progression; periodontal disease; intensive periodontal disease treatment

Outcome Measures

Primary Outcomes (1)

• Number of Participants Completing Study Protocol

  The investigators will determine the number of participants who complete baseline, month 4, month 8, and month 12 study visits.

  Baseline, Month 4, Month 8, Month 12

Secondary Outcomes (1)

• Change in Estimated Glomerular Filtration Rate

  Baseline, Month 4, Month 12

Study Arms (2)

Control/Delayed Treatment

NO INTERVENTION

Baseline panoramic x-ray (Panorex) and complete oral examinations at every visit. Rescue scaling and root planing only to sites of periodontal disease progression (since prior examination) of greater than 3mm. Subjects will be informed of their assignment to the delayed treatment group and provided referral list of local dentists should patient not feel comfortable waiting until end of study for full intensive periodontal disease treatment. Written and verbal instruction in oral hygiene. Provision of oral hygiene supplies.

Intensive periodontal disease treatment

ACTIVE COMPARATOR

Baseline panoramic x-ray (Panorex) and complete oral examinations at every visit. Intensive periodontal disease treatment to include administration of local anesthetic to up to two quadrants for scaling and root planing with ultrasonic and hand instruments. Minocycline will be applied to any sites with probing depth \>=5mm. Hopeless teeth in scaled quadrants will be extracted. Written and verbal instruction in oral hygiene. Provision of oral hygiene supplies.

Procedure: Scaling and root planing; Drug: Minocycline

Interventions

Scaling and root planing PROCEDURE

non-surgical periodontal disease treatment

Also known as: Deep cleaning, Subgingival cleaning

Intensive periodontal disease treatment

Minocycline DRUG

antibiotic microspheres

Also known as: Arestin

Intensive periodontal disease treatment

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-75 years
• Speaks English or Spanish
• At least two measurements of estimated glomerular filtration (eGFR) rate 15-59 ml/min/1.73m2 within the preceding 12 months
• No eGFR increase by \>= 50% in the preceding 6 months
• Moderate/severe periodontal disease in accordance with the Centers for Disease Control and Prevention/American Academy of Periodontology definition

You may not qualify if:

• Under age 20 or over age 75
• Unable to understand and provide informed consent
• Receiving current immunosuppressant therapy.
• Receiving current anticoagulation therapy resulting in an elevated prothrombin time or an International Normalized Ratio (INR) greater than 2.0
• Pregnant.
• Have fewer than 6 natural teeth
• Requires antibiotic prophylaxis for dental procedures as defined by the 2007 American Heart Association guidelines (patients with prosthetic heart valves, those with prosthetic material used for cardiac valve repair, those who have had a history of infective endocarditis, or those with congenital heart defects repaired with prosthetic material).
• Have severe dental disease defined as deep dental caries, endodontic involvement of one or more teeth, presence of abscesses of periodontal or endodontic origin, or dental conditions requiring immediate treatment.
• Have any hard or soft tissue lesion requiring further evaluation and/or treatment.
• Have known allergy to minocycline, tetracyclines, or polyglycolide polymers.

Sponsors & Collaborators

• University of California, San Francisco: lead

Related Publications (1)

• Grubbs V, Garcia F, Vittinghoff E, Jue BL, Ryder M, Lovett DH, Offenbacher S, Taylor G, Ganz P, Bibbins-Domingo K, Powe NR. Nonsurgical Periodontal Therapy in CKD: Findings of the Kidney and Periodontal Disease (KAPD) Pilot Randomized Controlled Trial. Kidney Med. 2019 Dec 2;2(1):49-58. doi: 10.1016/j.xkme.2019.09.005. eCollection 2020 Jan-Feb.

  PMID: 32734226 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Periodontal Diseases

Interventions

Tooth Exfoliation; Root Planing; Minocycline

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

A large trial with a true control group is needed to determine the extent to which periodontal treatment may slow the trajectory of kidney function deterioration.

Results Point of Contact

• Title: Dr. Vanessa Grubbs
• Organization: University of California, San Francisco

Vanessa.Grubbs@ucsf.edu

415-206-5649

Study Officials

• Vanessa Grubbs, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: March 1, 2013
• Study Start: February 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 30, 2019
• Results First Posted: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share