Renal Insufficiency ChronicPhase 4ETGPGKNCT02901743

Effect on Teeth and Gum Cleaning in Patients With Gum and Kidney Disease

A Phase 4 study testing Scaling and Root planing in people with Renal Insufficiency Chronic and Chronic Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main aim and objective of this study was to evaluate the effects of Non- surgical periodontal therapy on the subgingival microbiota and biochemical parameters in patients with chronic kidney disease and chronic periodontitis. Read more about this study

Who is it for?: Ages 35 to 75 years
Conditions the study is for: Renal Insufficiency Chronic, Chronic Periodontitis
What is being tested?: Scaling and Root planing
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: No sites listed yet
Study dates: Apr 2015to Jul 2015
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A total of 20 patients diagnosed with Chronic kidney disease, (having abnormal Glomerular filtration rate(GFR) and serum Creatinine levels.) and chronic periodontitis (with at least 15 teeth remaining, and with the presence of ≥4 sites in 3 different teeth having clinical attachment loss (CAL) of ≥ 4mm and bleeding on probing). (Group I)
20 patients diagnosed with chronic periodontitis only. (GroupII)

Who cannot join

Patients with HIV infection, pregnancy, lupus erythematosus, rheumatoid arthritis, any systemic disorder, periodontal therapy in the preceding 6 months, or on any course of antibiotic prophylaxis for periodontal procedures were excluded from the study

About this study

Official title: "Efficacy of Nonsurgical Periodontal Therapy in Patients With Chronic Renal Disease and Periodontitis: A Biochemical and Microbiological Assay"

Read the detailed description

The study was designed as a Non randomized prospective, interventional clinical trial. The sample size for the study was 40 individuals aged between 35-75 years, equally divided into two groups.

Group I--- Patients with Chronic kidney disease and chronic periodontitis (Test) Group II--- Patients with Chronic periodontitis only (Controls) At baseline both the groups were analyzed for clinical, microbiological and also biochemical parameters and underwent Non-surgical Periodontal treatment (i.e. scaling and root planning). All parameters were reassessed again after 3 months.

A total of 20 patients attending the outpatient wing of Hyderabad Kidney Centre , Malakpet,Hyderabad who were diagnosed clinically with Chronic Kidney disease and willing to participate in the study were included in the study.

Another 20 patients attending the outpatient wing of Department of periodontics, Panineeya Mahavidyalaya Institute of Dental Sciences \& Hospital, Hyderabad, diagnosed with Chronic Periodontitis and willing to participate in the study were taken.

Biochemical parameters considered included -serum creatin \& urinary albumin: creatin ratio.

Microbiological assay was done by Polymerase chain reaction test (PCR) i.e., pooled plaque samples were taken from both predialysis as well as chronic periodontitis patients.

Conditions: Renal Insufficiency Chronic, Chronic Periodontitis
Being tested: Scaling and Root planing
Medical subject headings: Renal Insufficiency, Chronic, Chronic Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Scaling and Root planingOther
All the patients were asked to use a preprocedural mouthrinse and scaling and rootplaning was done using ultrasonic scalers.

Study groups in NCT02901743
Study group	Role	What they receive
GroupI (Test)	Active comparator	20 patients with renal insufficiency chronic and chronic periodontitis underwent scaling and root planing. Clinical parameters( GI,PD,CAL) were assessed at baseline and after 3 months. 2ml blood was drawn to assess serum creatinine levels and urine analysis was done at baseline and after 3 months for urinary albumin: creatinine ratio.Pooled plaque samples were taken at baseline and after 3 months to assess the microbial activity of Treponema Denticola and Tannerella Forsythia by PCR. Receives: Other: Scaling and Root planing
Group II- (Control)	Active comparator	20 patients with chronic periodontitis who underwent scaling and root planing.Clinical parameters(GI,PD,CAL)were assessed at baseline and after 3 months. 2ml blood was drawn to assess seum creatnine levels and urine analysis was done at baseline and after 3 months for serum urinary Albumin:Creatinine ratio.Pooled plaque samples were taken at baseline and after 3 months to assess the microbial activity of Treponema denticola and Tannerella Forsythia by PCR. Receives: Other: Scaling and Root planing

What is being measured

The primary outcome is the main question the study is designed to answer.

Levels of Microbiological and Biochemical Parameters
Microbiological assay was done by PCR test i.e., pooled plaque samples were taken from both predialysis as well as chronic periodontitis patients at baseline and 3 months after scaling and root planing.
Supragingival plaque was removed carefully with a sterile scaler to prevent the contamination of the samples.Sample was harvested from the same site with a sterile Gracey curet 5-6 with one single vertical stroke on the root surface.
Biochemical assay was done by Modified Jaffe's reaction to assess the levels of Serum Creatinine and urine samples were taken to assess the Albumin:Creatinine ratio
Measured: Change in levels of Microbiological and Biochemical parameters were assessed at baseline and 3 months after scaling and rootplaning

Secondary outcomes (3)

Clinical parameter -Gingival Index (GI)
The Gingival index was assessed using a University of Carolina-15 (UNC-15) Probe.
Measured: Change in the GI was assessed at baseline and 3 months after Scaling and rootplaning
Clinical Parameters-Probing depth(PD) and Clinical attachment levels (CAL)
The Pd was assessed using UNC-15 Probe
Measured: Change in Pd was assessed at baseline and 3 months after scaling and rootplaning
Clinical Parameter- Clinical attachment levels(CAL)
The CAL was assessed using UNC-15 Probe
Measured: Change in CAL was assessed at baseline and 3 months after scaling and rootplaning

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Jul 2015

First posted15 Sep 2016 (estimated)
Study startApr 2015
Primary completionJun 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Renal Insufficiency ChronicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02901743
Sponsor's protocol ID: D 139206060
Acronym: ETGPGK
Status last verified: Sep 2016
First submitted: 25 Aug 2016
Last updated: 15 Sep 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Fisher MA, Taylor GW. A prediction model for chronic kidney disease includes periodontal disease. J Periodontol. 2009 Jan;80(1):16-23. doi: 10.1902/jop.2009.080226.
PubMed 19228085
Graziani F, Cei S, La Ferla F, Vano M, Gabriele M, Tonetti M. Effects of non-surgical periodontal therapy on the glomerular filtration rate of the kidney: an exploratory trial. J Clin Periodontol. 2010 Jul;37(7):638-43. doi: 10.1111/j.1600-051X.2010.01578.x. Epub 2010 May 25.
PubMed 20500539

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
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An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
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All Renal Insufficiency Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: "Efficacy of Nonsurgical Periodontal Therapy in Patients With Chronic Renal Disease and Periodontitis: A Biochemical and Microbiological Assay"
ClinicalTrials.gov ID: NCT02901743
Acronym / sponsor ID: ETGPGK / D 139206060
Conditions: Renal Insufficiency Chronic, Chronic Periodontitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
Study start: Apr 2015
Primary completion: Jun 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 15 Sep 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study was designed as a Non randomized prospective, interventional clinical trial. The sample size for the study was 40 individuals aged between 35-75 years, equally divided into two groups.

Biochemical parameters considered included -serum creatin \& urinary albumin: creatin ratio.

Microbiological assay was done by Polymerase chain reaction test (PCR) i.e., pooled plaque samples were taken from both predialysis as well as chronic periodontitis patients.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
GroupI (Test)	Active comparator	Other: Scaling and Root planing20 patients with renal insufficiency chronic and chronic periodontitis underwent scaling and root planing. Clinical parameters( GI,PD,CAL) were assessed at baseline and after 3 months. 2ml blood was drawn to assess serum creatinine levels and urine analysis was done at baseline and after 3 months for urinary albumin: creatinine ratio.Pooled plaque samples were taken at baseline and after 3 months to assess the microbial activity of Treponema Denticola and Tannerella Forsythia by PCR.
Group II- (Control)	Active comparator	Other: Scaling and Root planing20 patients with chronic periodontitis who underwent scaling and root planing.Clinical parameters(GI,PD,CAL)were assessed at baseline and after 3 months. 2ml blood was drawn to assess seum creatnine levels and urine analysis was done at baseline and after 3 months for serum urinary Albumin:Creatinine ratio.Pooled plaque samples were taken at baseline and after 3 months to assess the microbial activity of Treponema denticola and Tannerella Forsythia by PCR.

Who may qualify

Ages: 35 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

A total of 20 patients diagnosed with Chronic kidney disease, (having abnormal Glomerular filtration rate(GFR) and serum Creatinine levels.) and chronic periodontitis (with at least 15 teeth remaining, and with the presence of ≥4 sites in 3 different teeth having clinical attachment loss (CAL) of ≥ 4mm and bleeding on probing). (Group I)
20 patients diagnosed with chronic periodontitis only. (GroupII)

Key exclusion criteria (1 listed)

Patients with HIV infection, pregnancy, lupus erythematosus, rheumatoid arthritis, any systemic disorder, periodontal therapy in the preceding 6 months, or on any course of antibiotic prophylaxis for periodontal procedures were excluded from the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Scaling and Root planingAll the patients were asked to use a preprocedural mouthrinse and scaling and rootplaning was done using ultrasonic scalers.	Other	Group II- (Control), GroupI (Test)

Primary outcome

Levels of Microbiological and Biochemical Parameters
Time frame: Change in levels of Microbiological and Biochemical parameters were assessed at baseline and 3 months after scaling and rootplaning
Microbiological assay was done by PCR test i.e., pooled plaque samples were taken from both predialysis as well as chronic periodontitis patients at baseline and 3 months after scaling and root planing. Supragingival plaque was removed carefully with a sterile scaler to prevent the contamination of the samples.Sample was harvested from the same site with a sterile Gracey curet 5-6 with one single vertical stroke on the root surface. Biochemical assay was done by Modified Jaffe's reaction to assess the levels of Serum Creatinine and urine samples were taken to assess the Albumin:Creatinine ratio

3 secondary outcomes

Clinical parameter -Gingival Index (GI)
Time frame: Change in the GI was assessed at baseline and 3 months after Scaling and rootplaning
Clinical Parameters-Probing depth(PD) and Clinical attachment levels (CAL)
Time frame: Change in Pd was assessed at baseline and 3 months after scaling and rootplaning
Clinical Parameter- Clinical attachment levels(CAL)
Time frame: Change in CAL was assessed at baseline and 3 months after scaling and rootplaning

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
Background: PubMed 19228085Fisher MA, Taylor GW. A prediction model for chronic kidney disease includes periodontal disease. J Periodontol. 2009 Jan;80(1):16-23. doi: 10.1902/jop.2009.080226.
Background: PubMed 20500539Graziani F, Cei S, La Ferla F, Vano M, Gabriele M, Tonetti M. Effects of non-surgical periodontal therapy on the glomerular filtration rate of the kidney: an exploratory trial. J Clin Periodontol. 2010 Jul;37(7):638-43. doi: 10.1111/j.1600-051X.2010.01578.x. Epub 2010 May 25.
Individual participant dataSharing planned: No

Related trials for Renal Insufficiency Chronic

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rekha R Koduganti, MDS study director

Panineeya Institute Of Dental Sciences and Research centre

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Scaling and Root planing in people with Renal Insufficiency Chronic and Chronic Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Levels of Microbiological and Biochemical Parameters (time frame: Change in levels of Microbiological and Biochemical parameters were assessed at baseline and 3 months after scaling and rootplaning). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02901743, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.