ClinicalTrials.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has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.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

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Keywords

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

In context

Periodontitis

1,232 studies on the registry are indexed under Periodontitis; 295 are open to participants now.

This study's planned enrollment of 30 is below the median of 44 across 846 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.,
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

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05

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

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

  • Otherplacebo

    non surgical periodontal treatment+placebo for 2 months

06

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

07

Study locations

1 of 1 sites recruiting
  • Burapha University Hospital
    Chon Buri, 20130, Thailand
    Recruiting
    • Piyapat Kunsongkeit, DDS · Contactpkunsongkeit@gmail.com · +66870491014
    • Pechngam Chaivanit, MD · Contact+6638386554
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2017; primary completion for Feb 2018, 5 months later.

Of 18 phase 2 interventional studies under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 21. This study's planned 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2017
First posted
Sep 1, 2017
StartEst.
Aug 30, 2017
Primary completionEst.
Feb 19, 2018
CompletionEst.
Aug 19, 2018
Last update
Sep 1, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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Discussion

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Studies of the drug tested here: Ascorbic Acid

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