Vitamin C as an Adjunct in Periodontal Treatment in Type 2 Diabetes Mellitus Patients

August 30, 2017 updated by: Supanee Rassameemasmaung, Mahidol University

The Effect of Vitamin C as an Adjunct in Periodontal Treatment in Uncontrolled Type 2 Diabetes Mellitus Patients

Periodontitis patients with uncontrolled type 2 diabetes mellitus will receive non-surgical periodontal treatment and then be supplemented with daily 500 mg vitamin C (test group) or placebo (control group) for 2 months. Clinical parameters will be retrieved at baseline, at the end of week 4 and at the end of week 8.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Chon Buri, Thailand, 20130
        • Recruiting
        • Burapha University Hospital
        • Contact:
        • Contact:
          • Pechngam Chaivanit, MD
          • Phone Number: +6638386554

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • uncontrolled type 2 diabetes mellitus
  • periodontitis

Exclusion Criteria:

  • complications from diabetes mellitus, e.g., renal insufficiency
  • receive insulin
  • diseases that interfere with wound healing, e.g., HIV
  • receive one of the followings: tetracycline, acetaminophen, NSAID, warfarin, aluminum-containing antacids, barbiturates, phenobarbital, pentobarbital, secobarbital, hormone replacement therapy, chemotherapeutic drug, protease inhibitor
  • receive other vitamins or antibiotics within 6 months
  • smoking
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
placebo
Other: placebo
non surgical periodontal treatment+placebo for 2 months
Active Comparator: test group
vitamin C 500 mg oral capsule
Drug: Vitamin C 500 MG Oral Capsule
non surgical periodontal treatment+vitamin C 500 mg/day for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sulcus bleeding index
Time Frame: baseline, change from baseline sulcus bleeding index at 4 weeks, change from baseline sulcus bleeding index at 8 weeks
bleeding upon probing of gingival sulcus from the most severe periodontitis tooth
baseline, change from baseline sulcus bleeding index at 4 weeks, change from baseline sulcus bleeding index at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Nis Okuma, DDS, MD, M.Sc (Oral Medicine), faculty of dentistry, Mahidol university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 30, 2017

Primary Completion (Anticipated)

February 19, 2018

Study Completion (Anticipated)

August 19, 2018

Study Registration Dates

First Submitted

August 28, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

September 1, 2017

Study Record Updates

Last Update Posted (Actual)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/DT068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Periodontitis

Clinical Trials on Vitamin C 500 MG Oral Capsule

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe