The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: RCT
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01217281|
Recruitment Status : Active, not recruiting
First Posted : October 8, 2010
Last Update Posted : October 26, 2017
Periodontal disease is a bacterially-induced inflammation. As such, it can become a point of entry of bacteria, toxins and cytokines into the systemic blood circulation, thus adversely affecting the function of kidneys. This is turn can aggravate the condition of patients with CKD.
The study hypothesis is that periodontal therapy can improve renal function in patients with CKD and lower the blood levels of markers for systemic inflammation.
|Condition or disease||Intervention/treatment|
|Chronic Kidney Disease Periodontitis||Procedure: Full Mouth Non-Surgical Periodontal Therapy|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: A Randomized Clinical Trial|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||January 2019|
No Intervention: Control
Full mouth supra-gingival debridement using hand instruments and ultrasonic scalers, in one session. Patient motivation and oral hygiene instructions Review and prophylaxis at 1 month, 3 months and 6 months after initial treatment session.
Full mouth periodontal therapy provided at the end of the 6month period (supra and sub- gingival full mouth scaling)
Active Comparator: Test/ Non-surgical Periodontal Therapy
Full mouth periodontal therapy (sub and supra- gingival debridement) provided under local anaesthesia in two half-mouth sessions.
Review and prophylaxis 1 month, 3 months and 6 months after the end of the initial therapy.
Procedure: Full Mouth Non-Surgical Periodontal Therapy
Non-surgical Periodontal Therapy provided in two sessions, one for the right half and one for the left half of the dentition. Treatment sessions are provided within one week. No antibiotics or other adjunctive medications are to be used
- eGFR [ Time Frame: 6 months ]estimated Glomerular Filtration Rate
- Cystatin C [ Time Frame: 6 months ]Surrogate marker for filtration rate
- CRP [ Time Frame: 6 months ]
- d-8-iso prostaglandin F2a [ Time Frame: 6 months ]
- Level of IgG antibodies in serum against periodontal pathogens [ Time Frame: 6 months ]
Serum samples will be screened for the presence of IgG antibodies against the below mentioned periodontal pathogens, using the "checkerboard immunoblotting" method:
Porphyromonas gingivalis, Prevotella intermedia, Prevotella nigrescens, Bacteroides forsythus, Treponema denticola, Fusobacterium nucleatum, Actinobacillus actinomycetemcomitans, Campylobacter rectus, Eikenella corrodens, Peptostreptococcus micros, Veillonella parvula, Capnocytophaga ochracea, Streptococcus intermedius, Streptococcus sanguis και Streptococcus oralis.per
- Composition of dental plaque [ Time Frame: 6 months ]Samples of subgingival plaque will be assessed using DNA probes according to the "checkerboard DNA- DNA hybridization" method. DNA probes will be used against the following bacteria: Porphyromonas gingivalis, Prevotella intermedia, Prevotella nigrescens, Bacteroides forsythus, Treponema denticola, Fusobacterium nucleatum, Actinobacillus actinomycetemcomitans, Campylobacter rectus, Eikenella corrodens, Peptostreptococcus micros, Veillonella parvula, Capnocytophaga ochracea, Streptococcus intermedius, Streptococcus sanguis and Streptococcus oralis
- Il-6 [ Time Frame: 6 months ]
- TNF-α [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01217281
|University of Athens, Dental School, Department of Periodontology|
|Athens, Greece, 11527|
|Principal Investigator:||Phoebus N Madianos, PhD||University of Athens|