We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Non-Surgical Periodontal Therapy on Serum Albumin Levels of Patients on Maintenance Hemodialysis Therapy,

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Dr Arsalan Wahid, University of the Punjab.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01641757
First Posted: July 17, 2012
Last Update Posted: July 18, 2012
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.
Information provided by (Responsible Party):
Dr Arsalan Wahid, University of the Punjab
  Purpose
Periodontitis is a destructive chronic infection of the gums, ligaments, and bone, predominantly caused by Gram-negative bacteria. Individuals with periodontal disease are at increased risk of systemic diseases. Increased prevalence of periodontal disease has been reported in patients with chronic kidney disease, especially in dialysis patients. Chronic kidney disease (CKD) is the progressive loss of kidney function over time. When kidneys loose their 85-90 % function, dialysis is performed. Efficacy of dialysis is checked by serum albumin levels. Lower-than-normal levels of serum albumin may be a sign of kidney diseases. Hypoalbuminemia has been demonstrated to be a strong predictor of death in chronic renal failure. A proposed mechanism for the effect of periodontitis on the development of kidney disease is systemic inflammation. The deleterious effects of systemic inflammation on kidney function could occur during the period of active periodontal infection and accumulate during the life time of the individual. This randomized control trial is designed to observe the effect of non-surgical periodontal therapy on serum albumin levels of patients on maintenance hemodialysis therapy. Patients will undergo periodontal examination and their serum albumin levels will be checked. Then they will be randomly divided in two groups. One group will be given non surgical periodontal treatment and second group will be offered late treatment. After 6 weeks 1st group will be reevaluated by serum albumin level and periodontal examination to observe the effect of non-surgical periodontal therapy. Statistical analyses shall be performed using SPSS software. T tests and Chi-sq tests shall be used to test differences according to periodontal status for continuous and categorical variables, respectively. The level of significance is set at p<0.05.

Condition Intervention Phase
End Stage Renal Failure on Dialysis Periodontitis Procedure: non-surgical periodontal therapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Non-Surgical Periodontal Therapy on Serum Albumin Levels of Patients on Maintenance Hemodialysis Therapy, A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Dr Arsalan Wahid, University of the Punjab:

Primary Outcome Measures:
  • serum albumin levels [ Time Frame: 6 months ]
    serum albumin levels are considered to be strong predictor of death in dialysis patients. in this trial we want to see the effect of non surgical periodontal therapy on serum albumin levels of patients on maintenance dialysis therapy


Enrollment: 160
Study Start Date: May 2012
Estimated Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: periodontal treatment group
non surgical periodontal therapy will be given to study subjects which will be selected by randomization from total study sample. at the end of study, serum albumin levels of both study and control groups will be compared.
Procedure: non-surgical periodontal therapy
dental scaling and root planing of full mouth will be done
Other Name: dental scaling and root planing

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chronic Kidney Disease patients, who are receiving hemodialysis therapy for >3 months. of all ages and both gender and are able to give informed consent.
  2. Have at least 14 teeth (excluding third molars) in oral cavity shall be included in study.

Exclusion Criteria:

  1. Patients have had periodontal therapy <1 year.
  2. Diabetes Mellitus
  3. Liver disease
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01641757


Locations
Pakistan
Shaikh Zayed Medical Complex
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
University of the Punjab
Investigators
Study Director: Ayyaz A Khan, PhD Shaikh Zayed Medical CompleX lahore
  More Information

Publications:
Responsible Party: Dr Arsalan Wahid, Principal Investigator, University of the Punjab
ClinicalTrials.gov Identifier: NCT01641757     History of Changes
Other Study ID Numbers: arsalanmalik
First Submitted: July 10, 2012
First Posted: July 17, 2012
Last Update Posted: July 18, 2012
Last Verified: July 2012

Keywords provided by Dr Arsalan Wahid, University of the Punjab:
hemodialysis
periodontitis

Additional relevant MeSH terms:
Renal Insufficiency
Periodontitis
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Renal Insufficiency, Chronic