CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Nonsurgical periodontal therapy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01951547
NCT01951547N/ACompleted

The Effect of Non-surgical Periodontal Therapy on Host Response and Microbiological Profile of Type 2 Diabetics With Periodontal Disease.

University of Malaya·interventional·Posted Sep 26, 2013·Updated Sep 26, 2013

In Brief

A clinical study evaluating Nonsurgical periodontal therapy and Oral hygiene instructions for Chronic Periodontitis and Type 2 Diabetes. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMalaysia
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 26, 2013
Enrollment StartJan 1, 2010
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12.8 years ago

Interventions

Nonsurgical periodontal therapyprocedure

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.

Oral hygiene instructionsprocedure

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.