Glycemic Control in T2DM Through Non-Surgical Periodontal Therapy

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.

Conditions

• Chronic Periodontitis
• Type 2 Diabetes Mellitus

Interventions

DRUG

Metronidazole

Systemic AAT would contain Metronidazole (MET) 400 mg x 3 for 10 days

PROCEDURE

Scaling Root Planing

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.

BEHAVIORAL

Oral Hygiene Instructions

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.

Sponsors & Collaborators

• Higher Education Commission (Pakistan)

  collaborator OTHER

• Dow University of Health Sciences

  lead OTHER

Principal Investigators

• CHAIRPERSON, DEPARTMENT OF COMMUNITY & PREVENTIVE DENTISTRY · Dow University of Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-01

Primary Completion

2020-06-30

Completion

2020-07-30

Countries

• Pakistan

Study Locations