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

Sponsor
Mahidol University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03269799
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
11.6
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vitamin C 500 MG Oral Capsule
  • Other: placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effect of Vitamin C as an Adjunct in Periodontal Treatment in Uncontrolled Type 2 Diabetes Mellitus Patients
Anticipated Study Start Date :
Aug 30, 2017
Anticipated Primary Completion Date :
Feb 19, 2018
Anticipated Study Completion Date :
Aug 19, 2018

Arms and Interventions

Arm Intervention/Treatment
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
Placebo Comparator: control group

placebo

Other: placebo
non surgical periodontal treatment+placebo for 2 months

Outcome Measures

Primary Outcome Measures

  1. sulcus bleeding index [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Burapha University Hospital Chon Buri Thailand 20130

Sponsors and Collaborators

  • Mahidol University

Investigators

  • Principal Investigator: Nis Okuma, DDS, MD, M.Sc (Oral Medicine), Faculty of Dentistry, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Supanee Rassameemasmaung, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier:
NCT03269799
Other Study ID Numbers:
  • 2016/DT068
First Posted:
Sep 1, 2017
Last Update Posted:
Sep 1, 2017
Last Verified:
Aug 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Supanee Rassameemasmaung, Associate Professor, Mahidol University
uncontrolled type 2 diabetes mellitus
periodontitis
non surgical periodontal treatment
vitamin C
Additional relevant MeSH terms:
Periodontitis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Ascorbic Acid

Study Results

No Results Posted as of Sep 1, 2017