Glycemic Control in T2DM Through Non-Surgical Periodontal Therapy

NCT03343366 | Completed Phase 2 DMC

• 1 other identifier: DUHS/DR-O/2017/266
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

fasting blood glucose; fasting plasma insulin; HOMA-IR insulin resistance; clinical attachment loss

Outcome Measures

Primary Outcomes (1)

• Glycated Hemoglobin (HbA1c)

  To examine effects of three non-surgical periodontal therapies through change in HbA1c levels

  Change from baseline (0) to 3 months and 6 months post intervention

Secondary Outcomes (6)

• Clinical Periodontal Measure 1

  Change at 1 and 3 months post intervention in all three groups

• Clinical Periodontal Measure 2

  Change at 1 and 3 months post intervention in all three groups

• Clinical Periodontal Measure 3

  Change at 1 and 3 months post intervention in all three groups

• Fasting Blood Glucose (FBG)

  at 3 and 6 month follow-up between groups.

• Fasting Plasma Insulin (FPI) levels

  at 3 and 6 month follow-up between groups.

Study Arms (3)

Test Group 1

EXPERIMENTAL

The participants in this group will receive a combination of ultrasonic scaling and hand instrumentation required for planing of the root surfaces (SRP) followed by systemic AAT followed by routine warm salt water rinses for 3-5 days and OHI. 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. Systemic AAT would contain Metronidazole (MET) 400 mg x 3 for 10 days. 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.

Drug: Metronidazole; Procedure: Scaling Root Planing; Behavioral: Oral Hygiene Instructions

Test Group 2

ACTIVE COMPARATOR

The participants in this group will receive a combination of Scaling Root Planing followed by routine warm salt water rinses for 3-5 days and OHI. Same procedure for SRP and OHI will be followed as that followed in Test Group 1

Procedure: Scaling Root Planing; Behavioral: Oral Hygiene Instructions

Control Group 3

OTHER

The participants in this group will receive only routine warm salt water rinses for 3-5 days and Oral Hygiene Instructions as that followed in Test Group 1 and Test Group 2. However, after completing six (6) months of evaluation they will be provided DT either in the form of SRP+MET or SRP only in addition to OHI, whichever would be found to have a significant beneficial effect on CP.

Behavioral: Oral Hygiene Instructions

Interventions

Metronidazole DRUG

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

Also known as: Systemic Adjunct Antibiotic Therapy (AAT)

Test Group 1

Scaling Root Planing PROCEDURE

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.

Also known as: SRP

Test Group 1; Test Group 2

Oral Hygiene Instructions BEHAVIORAL

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.

Also known as: OHI

Control Group 3; Test Group 1; Test Group 2

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Pregnant or breast feeding women
• Gestational Diabetes
• Patients currently receiving dialysis
• Patients with cardiac pacemakers
• Alcoholic
• Patients with any serious concurrent disease or complication with \<1 year of life expectancy.
• Patients suffering from myelo-proliferating disorder (such as sickle cell disease) or under any such treatment that promotes a shift in the hemoglobin pattern.
• Under any anti-inflammatory drugs (daily for \>7 consecutive days) within last 2 months of baseline visit, other than low dose aspirin prescribed for Cardio-vascular disease
• Under any systemic immunosuppressive drugs like corticosteroids, cyclosporine etc.
• Under any systemic antibiotics for \>7 consecutive days within last four weeks of baseline visit.
• No medication for oral problems during last one month and during follow-up period that may affect interventions and HbA1c levels
• Any change in diabetes related medications in last 3 months of baseline visit, such as change in dose of any one hyperglycemic drug therapy by more than two-fold, addition or subtraction of an oral hypoglycemic agent or addition of insulin.
• Patients requiring any surgical (such as flap-surgery) or any non-surgical periodontal care that is restricted throughout study period depending upon the participants' group he/she may belong to.
• Patients with a history of night-grinding/ bruxism
• Patients with a history of allergic reaction with metronidazole

Sponsors & Collaborators

• Dow University of Health Sciences: lead
• Higher Education Commission (Pakistan): collaborator

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 00000, Pakistan

Location

Related Publications (1)

• Qureshi A, Haque Z, Bokhari SAH, Baloch AA. Evaluation of HbA1c in type-2 diabetes mellitus patients with periodontitis: preliminary findings of three-arm clinical trial. J Pak Med Assoc. 2020 Aug;70(8):1350-1356. doi: 10.5455/JPMA.22016.

  PMID: 32794485 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis; Diabetes Mellitus, Type 2

Interventions

Metronidazole

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

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• CHAIRPERSON, DEPARTMENT OF COMMUNITY & PREVENTIVE DENTISTRY

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: A parallel group, single blind three-arm design randomized controlled trial (RCT) will be conducted. The examiners, both for periodontal examination and laboratory investigations will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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).

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 17, 2017
• Study Start: January 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: July 30, 2020
• Last Updated: August 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: will be available by mid of year 2020
• Access Criteria: it will be accessible only to systematic reviewers on email request only

Locations

PA (1)