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

NCT02208739 | Completed DMC

• 1 other identifier: PPPC-C2
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

Chronic periodontitis; periodontal pathogens; inflammatory mediators; Non surgical periodontal therapy; Oral hygiene instructions; Polymerase chain reaction; Elisa

Outcome Measures

Primary Outcomes (1)

• Effect of NSPT vs OHI on probing pocket depth of subjects with chronic periodontitis

  Outcome measurements assessed are probing pocket depth

  Baseline to 3 months

Secondary Outcomes (7)

• Effect of NSPT vs OHI on microbiological parameters of subjects with chronic periodontitis

  Baseline to 3 months

• Effect of NSPT vs OHI on immunological parameters of subjects with chronic periodontitis

  Baseline to 3 months

• Effect of NSPT vs OHI on oral health related quality of life of subjects with chronic periodontitis

  Baseline to 3 months

• Effect of NSPT vs OHI on plaque index of subjects with chronic periodontitis

  Baseline to 3 months

• Effect of NSPT vs OHI on gingival bleeding index of subjects with chronic periodontitis

  Baseline to 3 months

Study Arms (2)

Nonsurgical periodontal therapy

EXPERIMENTAL

Nonsurgical periodontal therapy was given to all patients at baseline

Procedure: Nonsurgical periodontal therapy

Oral hygiene instructions

ACTIVE COMPARATOR

Oral hygiene instructions were given to all patients at baseline

Procedure: Nonsurgical periodontal therapy; Procedure: Oral hygiene instructions

Interventions

Nonsurgical periodontal therapy PROCEDURE

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.

Nonsurgical periodontal therapy; Oral hygiene instructions

Oral hygiene instructions PROCEDURE

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.

Oral hygiene instructions

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya

Kuala Lumpur, 50603, Malaysia

Location

Related Publications (2)

• Doungudomdacha S, Rawlinson A, Walsh TF, Douglas CW. Effect of non-surgical periodontal treatment on clinical parameters and the numbers of Porphyromonas gingivalis, Prevotella intermedia and Actinobacillus actinomycetemcomitans at adult periodontitis sites. J Clin Periodontol. 2001 May;28(5):437-45. doi: 10.1034/j.1600-051x.2001.028005437.x.

  PMID: 11350507 BACKGROUND

• Knofler GU, Purschwitz RE, Eick S, Pfister W, Roedel M, Jentsch HF. Microbiologic findings 1 year after partial- and full-mouth scaling in the treatment of moderate chronic periodontitis. Quintessence Int. 2011 Oct;42(9):e107-17.

  PMID: 21909493 BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rathna D Vaithilingam, MClinDent

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: August 5, 2014
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2014
• Last Updated: July 15, 2015

Record last verified: 2015-07

Locations

MY (1)