AzTrials
AzTrials

Chronic PeriodontitisPhase 2/3NCT03343366

Glycemic Control in T2DM Through Non-Surgical Periodontal Therapy

A Phase 2/3 study testing Metronidazole, Scaling Root Planing and Oral Hygiene Instructions in people with Chronic Periodontitis and Type 2 Diabetes Mellitus, run by Dow University of Health Sciences at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 35 to 65 years
What is being tested?
Metronidazole, Scaling Root Planing and Oral Hygiene Instructions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 sitePakistan
Study dates
1 Jan 2018to 30 Jul 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 35 to 65 years patients suffering from moderate to severe CP at baseline and having HbA1c level ≥7% and <10% at baseline with already diagnosed T2DM at least an year ago will be included as study sample. Moreover, those currently under oral glycemic therapy, having at least 16 natural teeth for the entire study duration and not under any definitive periodontal treatment since last 6 months of baseline visit will be considered as inclusion criteria along with no oral soft tissue lesions and those willing to sign informed consent will be considered to be recruited for this trial

Who cannot join

  • 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.
Show all 18Show fewer
  • 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
  • Patients with mentally or/ and gross physical disability
  • Failure to liaise on with the study protocol over the next 6 months
  • With drawl from participation

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Dow University of Health Sciences

    Karachi, Sindh, 00000

Other trials in Pakistan

About this study

Official title: Glycemic Control in Type-2 Diabetes Mellitus Patients Through Non-Surgical Periodontal Therapy: A Randomized Controlled Trial

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.

Read the 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.

Being tested
Metronidazole, Scaling Root Planing, Oral Hygiene Instructions
Keywords
fasting blood glucose, fasting plasma insulin, HOMA-IR insulin resistance, clinical attachment loss
Medical subject headings
Chronic Periodontitis, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetronidazoleDrug

    Also called Systemic Adjunct Antibiotic Therapy (AAT)

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

  • Scaling Root PlaningProcedure or surgery

    Also called SRP

    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.

  • Oral Hygiene InstructionsBehavioural

    Also called OHI

    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.

Study groups in NCT03343366
Study groupRoleWhat they receive
Test Group 1ExperimentalThe 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.
Receives: Drug: Metronidazole; Procedure: Scaling Root Planing; Behavioral: Oral Hygiene Instructions
Test Group 2Active comparatorThe 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
Receives: Procedure: Scaling Root Planing; Behavioral: Oral Hygiene Instructions
Control Group 3OtherThe 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.
Receives: Behavioral: Oral Hygiene Instructions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycated Hemoglobin (HbA1c)

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

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

Secondary outcomes (6)

  1. Clinical Periodontal Measure 1

    To examine the changes in clinical periodontal measures in terms of Clinical Attachment Loss(CAL)

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

  2. Clinical Periodontal Measure 2

    To examine the changes in clinical periodontal measures in terms of Periodontal Pocket Depth (PPD)

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

  3. Clinical Periodontal Measure 3

    To examine the changes in clinical periodontal measures in terms of probing (BOP)

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

  4. Fasting Blood Glucose (FBG)

    To identify an association of clinical periodontal changes on FBG

    Measured: at 3 and 6 month follow-up between groups.

  5. Fasting Plasma Insulin (FPI) levels

    To identify an association of clinical periodontal changes on FPI

    Measured: at 3 and 6 month follow-up between groups.

  6. HOMA-IR

    To identify an association of clinical periodontal changes on insulin resistance

    Measured: at 3 and 6 month follow-up between groups.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2017
  2. Study start1 Jan 2018
  3. Primary completion30 Jun 2020
  4. Study completion30 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03343366
Sponsor's protocol ID
DUHS/DR-O/2017/266
Status last verified
Aug 2020
First submitted
9 Nov 2017
Last updated
21 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: It will be available through thesis presentation

Publications

  • 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.

    PubMed 32794485

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Metronidazole, Scaling Root Planing and Oral Hygiene Instructions in people with Chronic Periodontitis and Type 2 Diabetes Mellitus, run by Dow University of Health Sciences at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycated Hemoglobin (HbA1c) (time frame: Change from baseline (0) to 3 months and 6 months post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03343366, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in