Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Periodontal Disease and Diabetes Mellitus Interrelationship Among Adult Malaysians

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: NCT01951547
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : September 26, 2013
Sponsor:
Information provided by (Responsible Party):
Dr Rathna Devi Vaithilingam, University of Malaya

Brief Summary:
Periodontitis, a chronic inflammatory disease which results in irreversible attachment loss, bone destruction and tooth loss, is a major oral health problem affecting 90.2% of Malaysian population. It was initially demonstrated that Type 2 Diabetes (T2D) was a risk factor for periodontitis and subsequently a two-way relationship between diabetes and periodontitis was proposed. Diabetes has been shown to cause defects in neutrophil function by overproduction of pro-inflammatory mediators such as Tumour necrosis factor-α, Interleukin-1β and Prostaglandin E2 by macrophages. The inflammatory mediators released in response to plaque have been reported to be insulin antagonists that disturb binding of insulin to its receptors and further complicate hyperglycaemia in T2D. The hyperglycaemia in diabetics promotes more pathogenic bacteria into the subgingival microenvironment making them more susceptible to chronic periodontitis. Studies however differ in the types of periodontal pathogens present in these pockets. At the same time, very few studies have quantified them. This study proposes to investigate the effect that non-surgical periodontal therapy (NSPT) has on the periodontal parameters, HbA1c levels, microbiological profile and CRP levels of T2D patients with chronic periodontitis as compared to oral hygiene education (OHE)alone.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Type 2 Diabetes Procedure: Nonsurgical periodontal therapy Procedure: Oral hygiene instructions Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Non-surgical Periodontal Therapy on Host Response and Microbiological Profile of Type 2 Diabetics With Periodontal Disease.
Study Start Date : January 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: Nonsurgical periodontal therapy
Nonsurgical periodontal therapy given at baseline
Procedure: Nonsurgical periodontal therapy
Periodontal intervention All patients were instructed in oral hygiene methods using a soft bristled toothbrush, a compact-tuft toothbrush, interdental brushes and dental floss utilizing the modified Bass technique. Full mouth debridement, which consisted of scaling and root planing, was done in a single visit for all subjects using an ultrasonic scaler and gracey curettes. Additionally, all patients were given a 0.12% Chlorhexidine mouthrinse (Hexipro®). They were instructed to rinse three times a day using 15ml each time for a period of 14 days commencing immediately after completion of full mouth debridement. Thereafter at each recall visit, all participants were re-motivated and professional prophylaxis was performed.

Procedure: Oral hygiene instructions
All patients were instructed in oral hygiene methods using a soft bristled toothbrush, a compact-tuft toothbrush, interdental brushes and dental floss utilizing the modified Bass technique.

Active Comparator: Oral hygiene instructions
Oral hygiene instructions given at baseline
Procedure: Oral hygiene instructions
All patients were instructed in oral hygiene methods using a soft bristled toothbrush, a compact-tuft toothbrush, interdental brushes and dental floss utilizing the modified Bass technique.




Primary Outcome Measures :
  1. Effect of periodontal intervention on plaque score levels in diabetics with periodontal disease [ Time Frame: Changes from baseline to 3 months ]
    Plaque score levels were evaluated at baseline, 2- and 3-months intervals

  2. Effect of periodontal intervention on gingival bleeding index of diabetics with periodontal disease [ Time Frame: Changes from baseline to 3 months ]
    Gingival bleeding index levels were evaluated at baseline, 2- and 3-months intervals

  3. Effect of periodontal intervention on probing pocket depths of diabetics with periodontal disease [ Time Frame: Changes from baseline to 3 months ]
    Probing pocket depths were evaluated at baseline, 2- and 3-months intervals

  4. Effect of periodontal intervention on probing attachment levels of diabetics with periodontal disease [ Time Frame: Changes from baseline to 3 months ]
    Probing attachment levels were evaluated at baseline, 2- and 3-months intervals


Secondary Outcome Measures :
  1. Effect Of periodontal intervention on microbiological profile of diabetics with periodontal disease [ Time Frame: Changes from baseline to 3 months ]
    Quantitative polymerase chain reaction (q-PCR) was used to determine the presence and levels of P. gingivalis, A. actinomycetemcomitans, P. intermedia and T. forsythia at baseline and 3 months follow up.

  2. Effect of periodontal intervention on HbA1c levels of diabetics with periodontal disease [ Time Frame: Changes from baseline to 3 months ]
    HbA1c levels were evaluated at baseline, 2- and 3-months intervals

  3. Effect Of periodontal intervention on hs-CRP levels in diabetics with periodontal disease [ Time Frame: Changes from baseline to 3 months ]
    HbA1c levels were evaluated at baseline and 3-months intervals



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.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes Mellitus patients whose diagnosis had been established (World Health Organization, 1999) and were on regular follow-ups for a minimum of 6 months.
  • Patients should have at least 12 teeth present
  • Patients with 2 or more interproximal sites (not on same tooth) with probing pocket depths of 5mm or more and 2 or more interproximal sites (not on same tooth)of probing attachment loss of 4mm or more which bled on probing.

Exclusion Criteria:

  • Patients who had history of systemic antibiotic usage over the previous 4 months
  • Patients who were pregnant
  • Patients who had received non-surgical periodontal treatment within the past 6 months
  • Patients who had received surgical periodontal treatment within the past 12 months
  • Patients who were smokers
  • Patients with a history of stroke or an acute cardiovascular event over the previous 12 months.
  • Patients who had their diabetic medication changed during the course of the study

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): NCT01951547


Locations
Layout table for location information
Malaysia
Faculty of Dentistry, University of Malaya
Kuala Lumpur, Malaysia, 50603
Sponsors and Collaborators
University of Malaya
Investigators
Layout table for investigator information
Principal Investigator: Rathna D Vaithilingam, MClinDent University of Malaya

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr Rathna Devi Vaithilingam, Dr, University of Malaya
ClinicalTrials.gov Identifier: NCT01951547     History of Changes
Other Study ID Numbers: UMRG344/11HTM
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: September 2013
Keywords provided by Dr Rathna Devi Vaithilingam, University of Malaya:
HbA1c
hs-CRP
non-surgical periodontal therapy
oral health education
probing pocket depth
plaque index
gingival bleeding index.
Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases