Glycemic Control in T2DM Through Non-Surgical Periodontal Therapy
Status:
Completed
Trial end date:
2020-07-30
Target enrollment:
Participant gender:
Summary
It is submitted that incident and prevalent chronic periodontal infection, known as chronic
periodontitis (CP) possibly has a causal relationship with diabetes mellitus (DM) having
effects on HbA1c, fasting plasma/ blood glucose (FPG/ FBG) and fasting plasma insulin (FPI)
levels. Experimental research has suggested that treating CP may improve glycemic control and
insulin resistance in Non-Insulin Dependent Type-2 DM patients (T2DM). However, there is
limited data concerning the need and effects of adjunct antibiotic therapy (AAT) along with
scaling root planning (SRP) in treating CP for long lasting results. Therefore, it is
suggested that further research with larger samples must be undertaken for a successful
periodontal therapy that may help improve glycemic control at desired levels and longer
durations. This study is designed to evaluate effects of periodontal therapy [SRP,
metronidazole (MET) and oral hygiene instructions (OHI)] through three-arm trial experiment
comprising of SRP+MET+OHI, SRP+OHI and OHI+ Delayed Therapy (DT) groups on HbA1c, FBG, FPI
levels and Insulin Resistance calculated through Homeostasis Model Assessment (HOMA-IR) to
fill research gap. This study will target large number of individuals (N > 1000) at trial
camps known as diabetes-periodontitis (Diab-Per) camps at three different campuses of Dow
University of Health Sciences hospitals to be screened for presence of signs and symptoms of
chronic periodontitis and type-2 diabetes Mellitus. The selected candidates will be referred
to the base camp for further evaluation to be enrolled in trial and recruit 150 participants
randomly allocated in each group (50 in each group). Post-therapy follow-up results will be
assessed at 1, 3 and 6 months to evaluate short and long term changes in status of CP, FBG,
FPI and HbA1c.