The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: RCT
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Chronic Kidney Disease Periodontitis |
Procedure: Full Mouth Non-Surgical Periodontal Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: A Randomized Clinical Trial |
- eGFR [ Time Frame: 6 months ] [ Designated as safety issue: No ]estimated Glomerular Filtration Rate
- Cystatin C [ Time Frame: 6 months ] [ Designated as safety issue: No ]Surrogate marker for filtration rate
- CRP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- d-8-iso prostaglandin F2a [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Level of IgG antibodies in serum against periodontal pathogens [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Serum samples will be screened for the presence of IgG antibodies against the below mentioned periodontal pathogens, using the "checkerboard immonoblotting" 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 ] [ Designated as safety issue: No ]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 bacteia: 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
- Il-6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- TNF-α [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Chronic Kidney Disease (Stage I, II, III, IV)
- At least 12 teeth present in the oral cavity
- Moderate to severe chronic periodontitis, which is defined as: at least 8 surfaces with periodontal pocket depth (PPD) ≥5mm and at least 4 surfaces with Clinical Attachment Loss (CAL) ≥4mm, distributed in at least two quadrants.
Exclusion Criteria:
- Patients that have had a renal transplant or undergoing dialysis
- Acute infections or use of antibiotics in the past 3 months.
- Auto-immune diseases, conditions that cause immunosuppression or use of immunosuppressant medication.
- Systemic conditions that require antibiotic prophylaxis for routine periodontal therapy.
- Non-surgical periodontal therapy in the past 6 months or surgical periodontal therapy in the past 12 months.
- Use of medication that can cause gingival hyperplasia such as cyclosporine or fenintoin.
- Myocardial infarction or cerebral vascular incident in the past 12 months or uncontrolled angina.
Contacts and Locations| Contact: Spyros Kouris, MClinDent | +30 210 806899 | spkouris@dent.uoa.gr |
| Contact: Phoebus N Madianos, PhD | +30 2107461181 | pmadian@dent.uoa.gr |
| Greece | |
| University of Athens, Dental School, Department of Periodontology | Recruiting |
| Athens, Greece, 11527 | |
| Principal Investigator: | Phoebus N Madianos, PhD | University of Athens |
More Information
No publications provided
| Responsible Party: | Ass. Prof. Phoebus N. Madianos, University of Athens |
| ClinicalTrials.gov Identifier: | NCT01217281 History of Changes |
| Other Study ID Numbers: | 143 |
| Study First Received: | October 6, 2010 |
| Last Updated: | October 7, 2010 |
| Health Authority: | Greece: Ethics Committee |
Keywords provided by University of Athens:
|
CKD, Renal, Chronic Kidney Disease, Periodontitis, Perio |
Additional relevant MeSH terms:
|
Kidney Diseases Periodontitis Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases |
Periodontal Diseases Mouth Diseases Stomatognathic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on June 18, 2013