Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Nonsurgical Periodontal Therapy Verses Oral Hygiene Instructions on Patients With Chronic Periodontitis

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: NCT02208739
Recruitment Status : Completed
First Posted : August 5, 2014
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
University of Malaya

Brief Summary:

Periodontitis, a bacterial dental biofilm based infectious disease, is a chronic inflammatory disease of the periodontium which results in irreversible destruction of supporting structures of the teeth such as periodontal ligaments, connective tissues, cementum and alveolar bone. More than 700 species of bacteria are estimated to be found in the sub-gingival dental biofilm in which periodontopathogens are found to be responsible in initiating periodontal disease. Chronic periodontitis, although termed as 'chronic', starts as an acute inflammation. Low levels of bacteremia and endotoxins provides a stimulus for the systemic inflammatory response. In periodontitis, the interaction of lipopolysaccharide (LPS) from gram-negative bacteria with host cells initiates the secretion of cytokines and the expression of cell adhesion molecules in gingival tissue which leads to loss of alveolar bone and connective tissues supporting the teeth.

In the management of chronic periodontitis, non surgical periodontal therapy (NSPT) which includes oral hygiene instruction (OHI), scaling and root planing, is administered to improve clinical parameters as well as controlling the bacterial count responsible in initiating the disease and the resultant inflammatory response. Success of the treatment can be analyzed when the clinical parameters, counts of the microbes is reduced and inflammatory response is controlled. Studies which have evaluated the microbiological and immunological response following NSPT clearly demonstrates an improvement in clinical parameters, reduction in inflammatory mediators present as well as a decrease in microbial count.

OHI which includes tooth brushing and inter-dental cleaning is found beneficial in removing microbial plaque, thus, preventing periodontal diseases such as gingivitis and periodontitis. Studies have evaluated the role of OHI on clinical and immunological parameters and microbiological profiles of periodontal maintenance subjects, while none of them evaluated its role alone in the management of chronic periodontitis subjects. Therefore, the purpose of the following investigation was to compare the changes in the clinical parameters, inflammatory mediators as well as level and frequency of detection of periodontopathogens that take place after 3-months of NSPT versus OHI and to evaluate if clinical parameters have an effect on these inflammatory mediators and microbiological changes.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis 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 : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Nonsurgical Periodontal Therapy Verses Oral Hygiene Instructions on Clinical Parameters as Well as Immunological and Microbial Profile of Patients With Chronic Periodontitis
Study Start Date : December 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: Nonsurgical periodontal therapy
Nonsurgical periodontal therapy was given to all patients at baseline
Procedure: Nonsurgical periodontal therapy
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.

Active Comparator: Oral hygiene instructions
Oral hygiene instructions were given to all patients at baseline
Procedure: Nonsurgical periodontal therapy
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.




Primary Outcome Measures :
  1. Effect of NSPT vs OHI on probing pocket depth of subjects with chronic periodontitis [ Time Frame: Baseline to 3 months ]
    Outcome measurements assessed are probing pocket depth


Secondary Outcome Measures :
  1. Effect of NSPT vs OHI on microbiological parameters of subjects with chronic periodontitis [ Time Frame: Baseline to 3 months ]
    Changes in subgingival microbiota were assessed as changes in frequency of detection and microbial count of A.actinomycetemcomitans, T.forsythia, P.gingivalis and P.intermedia from baseline to 3 months post therapy.

  2. Effect of NSPT vs OHI on immunological parameters of subjects with chronic periodontitis [ Time Frame: Baseline to 3 months ]
    Changes in immunological parameters were assessed as changes in levels of high-sensitivity C-reactive protein , Interleukin-1, Interleukin-6. Tumour Necrosis Factor alpha, adiponectin and resistin from baseline to 3 months post therapy.

  3. Effect of NSPT vs OHI on oral health related quality of life of subjects with chronic periodontitis [ Time Frame: Baseline to 3 months ]
    Changes in oral health related quality of life from baseline to 3 months post therapy in both treatment groups.

  4. Effect of NSPT vs OHI on plaque index of subjects with chronic periodontitis [ Time Frame: Baseline to 3 months ]
    Outcome measurements assessed are Plaque index

  5. Effect of NSPT vs OHI on gingival bleeding index of subjects with chronic periodontitis [ Time Frame: Baseline to 3 months ]
    Outcome measurements assessed are Gingival bleeding index

  6. Effect of NSPT vs OHI on clinical attachment level of subjects with chronic periodontitis [ Time Frame: Baseline to 3 months ]
    Outcome measurements assessed are clinical attachment levels

  7. Effect of NSPT vs OHI on oral health related quality of life of subjects with chronic periodontitis [ Time Frame: Baseline to 3 months ]
    Outcome measurements assessed are oral health related quality of life



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:

  • Patients should have at least 12 teeth present
  • Patients with Moderate to Advanced Chronic periodontitis
  • 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.

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): NCT02208739


Locations
Layout table for location information
Malaysia
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:
Layout table for additonal information
Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT02208739     History of Changes
Other Study ID Numbers: PPPC-C2
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: July 15, 2015
Last Verified: July 2015

Keywords provided by University of Malaya:
Chronic periodontitis
periodontal pathogens
inflammatory mediators
Non surgical periodontal therapy
Oral hygiene instructions
Polymerase chain reaction
Elisa

Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases