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

Primary Purpose

Diabetes Mellitus Type 2 With Hyperglycemia, Periodontitis

Status
Unknown status
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Vitamin C 500 MG Oral Capsule
placebo
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 With Hyperglycemia focused on measuring uncontrolled type 2 diabetes mellitus, periodontitis, non surgical periodontal treatment, vitamin C

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Burapha University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

test group

control group

Arm Description

vitamin C 500 mg oral capsule

placebo

Outcomes

Primary Outcome Measures

sulcus bleeding index
bleeding upon probing of gingival sulcus from the most severe periodontitis tooth

Secondary Outcome Measures

Full Information

First Posted
August 28, 2017
Last Updated
August 30, 2017
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT03269799
Brief Title
Vitamin C as an Adjunct in Periodontal Treatment in Type 2 Diabetes Mellitus Patients
Official Title
The Effect of Vitamin C as an Adjunct in Periodontal Treatment in Uncontrolled Type 2 Diabetes Mellitus Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2017 (Anticipated)
Primary Completion Date
February 19, 2018 (Anticipated)
Study Completion Date
August 19, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2 With Hyperglycemia, Periodontitis
Keywords
uncontrolled type 2 diabetes mellitus, periodontitis, non surgical periodontal treatment, vitamin C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
test group
Arm Type
Active Comparator
Arm Description
vitamin C 500 mg oral capsule
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Vitamin C 500 MG Oral Capsule
Intervention Description
non surgical periodontal treatment+vitamin C 500 mg/day for 2 months
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
non surgical periodontal treatment+placebo for 2 months
Primary Outcome Measure Information:
Title
sulcus bleeding index
Description
bleeding upon probing of gingival sulcus from the most severe periodontitis tooth
Time Frame
baseline, change from baseline sulcus bleeding index at 4 weeks, change from baseline sulcus bleeding index at 8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piyapat Kunsongkeit, DDS
Phone
+66870491014
Email
pkunsongkeit@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Supanee Rassameemasmaung, DDS, M.Sc (Periodontics), Ph.D
Phone
+66867766255
Email
supanee.ras@mahidol.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nis Okuma, DDS, MD, M.Sc (Oral Medicine)
Organizational Affiliation
Faculty of Dentistry, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burapha University Hospital
City
Chon Buri
ZIP/Postal Code
20130
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piyapat Kunsongkeit, DDS
Phone
+66870491014
Email
pkunsongkeit@gmail.com
First Name & Middle Initial & Last Name & Degree
Pechngam Chaivanit, MD
Phone
+6638386554

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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