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

NCT01641757 | Unknown Phase 2 DMC

• 1 other identifier: arsalanmalik
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Failure on Dialysis; Periodontitis

Keywords

hemodialysis; periodontitis

Outcome Measures

Primary Outcomes (1)

• serum albumin levels

  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

  6 months

Study Arms (1)

periodontal treatment group

EXPERIMENTAL

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

Interventions

non-surgical periodontal therapy PROCEDURE

dental scaling and root planing of full mouth will be done

Also known as: dental scaling and root planing

periodontal treatment group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Have at least 14 teeth (excluding third molars) in oral cavity shall be included in study.

You may not qualify if:

• Patients have had periodontal therapy \<1 year.
• Diabetes Mellitus
• Liver disease

Sponsors & Collaborators

• University of the Punjab: lead

Study Sites (1)

Shaikh Zayed Medical Complex

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• Bots CP, Poorterman JH, Brand HS, Kalsbeek H, van Amerongen BM, Veerman EC, Nieuw Amerongen AV. The oral health status of dentate patients with chronic renal failure undergoing dialysis therapy. Oral Dis. 2006 Mar;12(2):176-80. doi: 10.1111/j.1601-0825.2005.01183.x.

  PMID: 16476040 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Interventions

Dental Scaling; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Prophylaxis; Periodontics; Dentistry; Preventive Dentistry; Subgingival Curettage

Study Officials

• Ayyaz A Khan, PhD

  Shaikh Zayed Medical CompleX lahore

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 17, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 18, 2012

Record last verified: 2012-07

Locations

PA (1)