CClinicalTrials.gg
Status unknownNCT03269799Updated Sep 1, 2017

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

A Phase 2 interventional study of Vitamin C 500 MG Oral Capsule and placebo in Diabetes Mellitus Type 2 With Hyperglycemia and Periodontitis, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Per ClinicalTrials.gov, last updated 2017-09-01.

Sponsored by Mahidol University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus Type 2 With Hyperglycemia
  • Periodontitis

Keywords

  • uncontrolled type 2 diabetes mellitus
  • periodontitis
  • non surgical periodontal treatment
  • vitamin C
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • uncontrolled type 2 diabetes mellitus
  • periodontitis

Exclusion criteria

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    test group

    vitamin C 500 mg oral capsule

    Drug: Vitamin C 500 MG Oral Capsule

  • Placebo comparator
    control group

    placebo

    Other: placebo

Interventions

  • DrugVitamin C 500 MG Oral Capsule

    non surgical periodontal treatment+vitamin C 500 mg/day for 2 months

  • Otherplacebo

    non surgical periodontal treatment+placebo for 2 months

05

What researchers measure

Primary outcomes

  1. sulcus bleeding index

    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

06

Study locations

1 of 1 sites recruiting
  • Burapha University Hospital
    Chon Buri, 20130, Thailand
    • Piyapat Kunsongkeit, DDS · Contact · pkunsongkeit@gmail.com · +66870491014
    • Pechngam Chaivanit, MD · Contact · +6638386554
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03269799
Lead sponsor
Mahidol University
Responsible party
Supanee Rassameemasmaung (Associate Professor, Mahidol University) — Principal investigator
First posted
Sep 1, 2017
Start date
Aug 30, 2017 (estimated)
Primary completion
Feb 19, 2018 (estimated)
Completion
Aug 19, 2018 (estimated)
Last update
Sep 1, 2017

Study contacts

Piyapat Kunsongkeit, DDS
Contact
pkunsongkeit@gmail.com
+66870491014
Supanee Rassameemasmaung, DDS, M.Sc (Periodontics), Ph.D
Contact
supanee.ras@mahidol.ac.th
+66867766255
Nis Okuma, DDS, MD, M.Sc (Oral Medicine)
principal investigator · Faculty of Dentistry, Mahidol University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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