Trial Outcomes & Findings for Kidney and Periodontal Disease Study (NCT NCT01802216)
NCT ID: NCT01802216
Last Updated: 2019-04-30
Results Overview
The investigators will determine the number of participants who complete baseline, month 4, month 8, and month 12 study visits.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Baseline, Month 4, Month 8, Month 12
Results posted on
2019-04-30
Participant Flow
This study enrolled English and Spanish-speaking patients 20-75 years old receiving primary care within the San Francisco Community Health Network. Patients with chronic kidney disease, not on dialysis, and moderate to severe periodontal disease are invited to participate.
Participants are assigned in a 2:1 ratio to control or intensive treatment group, randomization is stratified by presence of diabetes. Enrollment began February 2014 until September 2016. 101 participants attended the in-person oral exam screening. 55 were randomized, 46 were excluded (41 did not meet periodontal disease criteria and 5 declined.
Participant milestones
| Measure |
Control/Delayed Treatment
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
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.
Scaling and root planing: non-surgical periodontal disease treatment
Minocycline: antibiotic microspheres
|
|---|---|---|
|
Baseline
STARTED
|
17
|
34
|
|
Baseline
COMPLETED
|
17
|
34
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
4 Month Visit
STARTED
|
17
|
34
|
|
4 Month Visit
COMPLETED
|
14
|
30
|
|
4 Month Visit
NOT COMPLETED
|
3
|
4
|
|
8 Month Visit
STARTED
|
17
|
34
|
|
8 Month Visit
COMPLETED
|
14
|
29
|
|
8 Month Visit
NOT COMPLETED
|
3
|
5
|
|
12 Month Visit
STARTED
|
17
|
34
|
|
12 Month Visit
COMPLETED
|
14
|
30
|
|
12 Month Visit
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Control/Delayed Treatment
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
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.
Scaling and root planing: non-surgical periodontal disease treatment
Minocycline: antibiotic microspheres
|
|---|---|---|
|
4 Month Visit
Participant did not show to visit
|
3
|
4
|
|
8 Month Visit
Participant did not show to visit
|
3
|
5
|
|
12 Month Visit
Participant did not show to visit
|
3
|
4
|
Baseline Characteristics
Kidney and Periodontal Disease Study
Baseline characteristics by cohort
| Measure |
Control/Delayed Treatment
n=17 Participants
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
n=34 Participants
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.
Scaling and root planing: non-surgical periodontal disease treatment
Minocycline: antibiotic microspheres
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 4, Month 8, Month 12The investigators will determine the number of participants who complete baseline, month 4, month 8, and month 12 study visits.
Outcome measures
| Measure |
Control/Delayed Treatment
n=17 Participants
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
n=34 Participants
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.
Scaling and root planing: non-surgical periodontal disease treatment
Minocycline: antibiotic microspheres
|
|---|---|---|
|
Number of Participants Completing Study Protocol
Completed Baseline Visit
|
17 Participants
|
34 Participants
|
|
Number of Participants Completing Study Protocol
Completed 4 Month Visit
|
14 Participants
|
30 Participants
|
|
Number of Participants Completing Study Protocol
Completed 8 Month Visit
|
14 Participants
|
29 Participants
|
|
Number of Participants Completing Study Protocol
Completed 12 Month Visit
|
14 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 12Using the creatinine-based CKD-EPI equation, the investigators will determine change in estimated glomerular filtration rate from baseline to 12 month by individual and treatment group
Outcome measures
| Measure |
Control/Delayed Treatment
n=17 Participants
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
n=34 Participants
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.
Scaling and root planing: non-surgical periodontal disease treatment
Minocycline: antibiotic microspheres
|
|---|---|---|
|
Change in Estimated Glomerular Filtration Rate
Baseline Visit
|
46.3 mL/min/1.73m^2
Standard Deviation 10.8
|
43.4 mL/min/1.73m^2
Standard Deviation 14.7
|
|
Change in Estimated Glomerular Filtration Rate
4 Month Vist
|
44.7 mL/min/1.73m^2
Standard Deviation 12.1
|
43.2 mL/min/1.73m^2
Standard Deviation 16.6
|
|
Change in Estimated Glomerular Filtration Rate
12 month Visit
|
45.6 mL/min/1.73m^2
Standard Deviation 12.4
|
42.4 mL/min/1.73m^2
Standard Deviation 18.3
|
Adverse Events
Control/Delayed Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intensive Periodontal Disease Treatment
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control/Delayed Treatment
n=17 participants at risk
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
n=34 participants at risk
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.
Scaling and root planing: non-surgical periodontal disease treatment
Minocycline: antibiotic microspheres
|
|---|---|---|
|
General disorders
Minocycline Reaction
|
0.00%
0/17 • Participants were asked of adverse events at their baseline, 4 month, 8 month and 12 month visits. Participants could also contact the study coordinator should any adverse events happen between visits. 3 years, 6 months
|
2.9%
1/34 • Number of events 1 • Participants were asked of adverse events at their baseline, 4 month, 8 month and 12 month visits. Participants could also contact the study coordinator should any adverse events happen between visits. 3 years, 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Vanessa Grubbs
University of California, San Francisco
Phone: 415-206-5649
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place