The Periodontal Disease and Diabetes Mellitus Interrelationship Among Adult Malaysians

NCT01951547 | Completed DMC

• 1 other identifier: UMRG344/11HTM
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis; Type 2 Diabetes

Keywords

HbA1c; hs-CRP; non-surgical periodontal therapy; oral health education; probing pocket depth; plaque index; gingival bleeding index.

Outcome Measures

Primary Outcomes (4)

• Effect of periodontal intervention on plaque score levels in diabetics with periodontal disease

  Plaque score levels were evaluated at baseline, 2- and 3-months intervals

  Changes from baseline to 3 months

• Effect of periodontal intervention on gingival bleeding index of diabetics with periodontal disease

  Gingival bleeding index levels were evaluated at baseline, 2- and 3-months intervals

  Changes from baseline to 3 months

• Effect of periodontal intervention on probing pocket depths of diabetics with periodontal disease

  Probing pocket depths were evaluated at baseline, 2- and 3-months intervals

  Changes from baseline to 3 months

• Effect of periodontal intervention on probing attachment levels of diabetics with periodontal disease

  Probing attachment levels were evaluated at baseline, 2- and 3-months intervals

  Changes from baseline to 3 months

Secondary Outcomes (3)

• Effect Of periodontal intervention on microbiological profile of diabetics with periodontal disease

  Changes from baseline to 3 months

• Effect of periodontal intervention on HbA1c levels of diabetics with periodontal disease

  Changes from baseline to 3 months

• Effect Of periodontal intervention on hs-CRP levels in diabetics with periodontal disease

  Changes from baseline to 3 months

Study Arms (2)

Nonsurgical periodontal therapy

EXPERIMENTAL

Nonsurgical periodontal therapy given at baseline

Procedure: Nonsurgical periodontal therapy; Procedure: Oral hygiene instructions

Oral hygiene instructions

ACTIVE COMPARATOR

Oral hygiene instructions given at baseline

Procedure: Oral hygiene instructions

Interventions

Nonsurgical periodontal therapy PROCEDURE

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.

Nonsurgical periodontal therapy

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.

Nonsurgical periodontal therapy; 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:

• 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.

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.
• Patients who had their diabetic medication changed during the course of the study

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry, University of Malaya

Kuala Lumpur, 50603, Malaysia

Location

Related Publications (6)

• Taiyeb-Ali TB, Raman RP, Vaithilingam RD. Relationship between periodontal disease and diabetes mellitus: an Asian perspective. Periodontol 2000. 2011 Jun;56(1):258-68. doi: 10.1111/j.1600-0757.2010.00370.x. No abstract available.

  PMID: 21501247 BACKGROUND

• Taylor GW, Borgnakke WS. Periodontal disease: associations with diabetes, glycemic control and complications. Oral Dis. 2008 Apr;14(3):191-203. doi: 10.1111/j.1601-0825.2008.01442.x.

  PMID: 18336370 BACKGROUND

• Taylor GW, Burt BA, Becker MP, Genco RJ, Shlossman M, Knowler WC, Pettitt DJ. Severe periodontitis and risk for poor glycemic control in patients with non-insulin-dependent diabetes mellitus. J Periodontol. 1996 Oct;67(10 Suppl):1085-93. doi: 10.1902/jop.1996.67.10s.1085.

  PMID: 8910827 BACKGROUND

• Boutaga K, van Winkelhoff AJ, Vandenbroucke-Grauls CM, Savelkoul PH. Comparison of real-time PCR and culture for detection of Porphyromonas gingivalis in subgingival plaque samples. J Clin Microbiol. 2003 Nov;41(11):4950-4. doi: 10.1128/JCM.41.11.4950-4954.2003.

  PMID: 14605122 BACKGROUND

• Boutaga K, van Winkelhoff AJ, Vandenbroucke-Grauls CM, Savelkoul PH. The additional value of real-time PCR in the quantitative detection of periodontal pathogens. J Clin Periodontol. 2006 Jun;33(6):427-33. doi: 10.1111/j.1600-051X.2006.00925.x.

  PMID: 16677332 BACKGROUND

• Raman RP, Taiyeb-Ali TB, Chan SP, Chinna K, Vaithilingam RD. Effect of nonsurgical periodontal therapy verses oral hygiene instructions on type 2 diabetes subjects with chronic periodontitis: a randomised clinical trial. BMC Oral Health. 2014 Jun 25;14:79. doi: 10.1186/1472-6831-14-79.

  PMID: 24965218 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 30, 2013
• First Posted: September 26, 2013
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 26, 2013

Record last verified: 2013-09

Locations

MY (1)