Glycemic Control in T2DM Through Non-Surgical Periodontal Therapy
Condition: Chronic Periodontitis; Type 2 Diabetes Mellitus
MeSH terms: Periodontitis; Chronic Periodontitis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      The overall evidence that CP has a role in the causal pathway of DM is yet limited and
      inconsistent. Although intervention research has suggested that treating CP may improve
      glycemic control and insulin resistance in Type-2 DM patients; yet there is limited data
      concerning the effects of adjunct antibiotic therapy (AAT) in addition to scaling root
      planning (SRP) in treating CP for long lasting results. Therefore, it is suggested that
      further research with bigger samples must be undertaken for a successful periodontal therapy
      that may help improve glycemic control at desired levels and long durations.

      This study is designed to evaluate the effects of periodontal therapy [SRP, metronidazole
      (MET) and oral hygiene instructions (OHI)] through a three-arm trial comprising of
      SRP+MET+OHI group, SRP+OHI group and OHI+ Delayed Therapy (DT) group, on HbA1c, FBG, FPI
      levels and Insulin Resistance calculated through Homeostasis Model Assessment (HOMA-IR) to
      fill the research gap.

      A parallel group, single blind three-arm design randomized controlled trial (RCT) will be
      conducted over a period of approximately 2 years.

      More than 1000 patients will be screened for CP with T2DM to recruit 150 participants for the
      study. They will be randomly allocated in each group (with 50 in each group). Post-therapy
      follow-up will be for 1, 3 and 6 months to evaluate short term and long term changes in
      status of CP, FBG, FPI and HbA1c respectively.

      Structured screening form will be used to collect baseline information. HbA1c, FBG levels and
      IL will be recorded at standardized lab, whereas, CP will be evaluated using standardized
      periodontal indices by calibrated examiners.

      Stata version 11.0 will be used for all kind of data management. Descriptive analysis will be
      performed using frequency percentages of the categorical variables whereas, mean (standard
      deviation) will be calculated for all continuous study variables. Inferential statistics will
      include Chi-square test to assess proportional differences of the categorical variables
      between the three interventional groups. Whereas, one-way Analysis of Variance test (ANOVA)
      will be used to evaluate the mean differences of the continuous variables in three different
      groups. McNemar's Chi-square and Repeated Measure Analysis of Variance (RMANOVA) will be used
      to assess differences in categorical and continuous variables respectively over time for each
      intervention group; and particularly to assess second secondary study objective. For insulin
      resistance HOMA-IR will be calculated to assess an association between CP and insulin
      resistance.
    

Intervention name(s): Metronidazole; Scaling Root Planing; Oral Hygiene Instructions
Intervention type(s): Drug; Procedure; Behavioral
Intervention description(s): Systemic AAT would contain Metronidazole (MET) 400 mg x 3 for 10 days; SRP will be performed using ultrasonic scaling device at medium intensity. In addition to ultrasonic scalar, hand instrumentation (using sharpened and sterilized curettes) may also be used if required to smoothen certain irregular areas of root surface until the surfaces are smooth.; OHI would include brushing teeth using soft bristles toothbrush and fluoridated toothpaste twice daily (morning after breakfast and night before sleeping) using Modified Bass Technique.
Other intervention name(s): Systemic Adjunct Antibiotic Therapy (AAT); SRP; OHI
Intervention MeSH terms: Anti-Bacterial Agents; Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This multi-centric randomized controlled trial (RCT) will be conducted on the baseline sample derived from periodontal clinics of dental institutes of Dow University of Health Sciences. More than 1000 patients will be screened to recruit 150 calculated sample participants (with 50 in each group) with reference to 0.7%, 0.6% reduction and no reduction (0.06%) in the baseline mean HbA1c over a period of 3 months among SRP+AAT, SRP Only and no treatment groups respectively(48) the calculated sample size is 35 in each group (1:1:1) with 99% power of test and 99% confidence interval. Adding 40% dropout rate expected over 6-months follow-up, 49 participants in each group will be required that will be rounded off to 50 in each group (with a ratio of 1:1:1).
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: fasting blood glucose; fasting plasma insulin; HOMA-IR insulin resistance; clinical attachment loss