Demographics |
Country |
Brazil |
China |
Switzerland |
Colombo |
Adelide, Australia |
USA |
|
Type of Study |
RCT |
RCT |
Exploratory trial |
RCT |
RCT protocol |
RCT |
|
Number of Groups |
G1: 21 predialysis patients G2: 19 with chronic periodontitis with no history of CKD |
Intervention=48 Control=49 |
Intervention =20 NA |
Intervention=16 CKD Patients Control=14 systemically healthy |
Intervention=300 Control=300 |
Intervention=34 Control=17 |
Participation Details |
Age |
36-76 years |
55-60 years |
35-75 years |
35-76 years |
18+ |
34-73 years |
|
Gender (M/F) |
NR |
NR |
Exploratory trial |
9 females in IG and 10 in CG |
NR |
|
|
Type of periodontal disease |
Chronic periodontitis |
Chronic periodontitis |
Generalized Chronic periodontitis |
Chronic periodontitis |
Periodontal disease |
Chronic periodontitis |
|
Grade of chronic kidney disease |
Grade 1 GFR-89-15ml/min |
ESRD |
Systemically healthy |
Grade 1 GFR between 89-15 ml/l |
Grade 3-5 |
Grade 1 |
Intervention |
Type |
SCRP + oral hygiene instructions |
SCRP + oral hygiene instructions |
SCRP |
SCRP + oral hygiene instructions |
SCRP + oral hygiene instructions |
SCRP |
|
Duration |
3 months |
36 months |
6 months |
11 months |
24 months |
12 months |
|
Frequency |
Baseline, 3 months |
Baseline, 6 weeks,3 months,6 months |
BL, 1 day, 7 days, 30 days, 90 days, 180 days |
Baseline, 3 months |
Baseline, 3 months, 6 months |
BL, 4 months, 8 months, 12 months |
Outcomes |
Parameters |
Primary - PI, CI, CAL, BOP, SUP |
Primary: PI, PPD, BOP, GR, CAL. Secondary: tnfalfa.IL-6, CRP, ferritin, Alb, BUN, Cr, ALC |
Positive with respect to periodontal parameters. |
Primary: microbiological assessment, secondary: PPD, CAL, VP, BOP, SUP |
Primary: change in carotid intima-media thickness secondary: progression of CKD |
Accepted manuscript |
|
Technique/Definition |
CAL>4mm and BOP, secondary - GFR, serum creatinine. |
>1mm CAL as per AAP, 16 teeth, third molars excluded |
Statistically significant improvement in periodontal parameters only |
15 teeth,>4sites,3 different teeth CAL>4mm |
Dialysis; egfr levels of <60 ml/min/1.73 m2 (CKD |
|
|
Time of reporting |
3 months Both groups responded well, contrary to the original hypothesis. |
6 months - (IG- 6 weeks- 48, 3 months - 48 , 6 months - 46) (CG- 6weeks - 48, 3months - 48, 6 months - 46) |
6 months - (1 day, 7 day, 30 days, 90 days, 120 days - 19) |
3 months -(IG- 9, CG-10) |
Stages 3 to 5); iii. ACR ≥30 mg/mmol irrespective of Egfr (CKD Stages 1 and 2); iv. Diabetes plus albuminuria |
|