Diabetes Mellitus Type 2 With HyperglycemiaPhase 2NCT03269799
Vitamin C as an Adjunct in Periodontal Treatment in Type 2 Diabetes Mellitus Patients
A Phase 2 study testing Vitamin C 500 MG Oral Capsule in people with Diabetes Mellitus Type 2 With Hyperglycemia and Periodontitis, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus Type 2 With Hyperglycemia, Periodontitis
- What is being tested?
- Vitamin C 500 MG Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 30 Aug 2017to 19 Aug 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- uncontrolled type 2 diabetes mellitus
- periodontitis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Supanee Rassameemasmaung, DDS, M.Sc (Periodontics), Ph.D contact
Thailand1 site, 1 recruiting
- Recruiting
Burapha University Hospital
Chon Buri, 20130
Piyapat Kunsongkeit, DDS, +66870491014, pkunsongkeit@gmail.com
Pechngam Chaivanit, MD, +6638386554
About this study
Official title: 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.
- Being tested
- Vitamin C 500 MG Oral Capsule, placebo
- Keywords
- uncontrolled type 2 diabetes mellitus, periodontitis, non surgical periodontal treatment, vitamin C
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C 500 MG Oral CapsuleDrug
non surgical periodontal treatment+vitamin C 500 mg/day for 2 months
placeboOther
non surgical periodontal treatment+placebo for 2 months
| Study group | Role | What they receive |
|---|---|---|
| test group | Active comparator | vitamin C 500 mg oral capsule Receives: Drug: Vitamin C 500 MG Oral Capsule |
| control group | Placebo comparator | placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
sulcus bleeding index
bleeding upon probing of gingival sulcus from the most severe periodontitis tooth
Measured: baseline, change from baseline sulcus bleeding index at 4 weeks, change from baseline sulcus bleeding index at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start30 Aug 2017 (estimated)
- Primary completion19 Feb 2018 (estimated)
- Study completion19 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 With HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supanee Rassameemasmaung, Mahidol University
- Investigators
- Nis Okuma, DDS, MD, M.Sc (Oral Medicine), Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269799
- Sponsor's protocol ID
- 2016/DT068
- Status last verified
- Aug 2017
- First submitted
- 28 Aug 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin C as an Adjunct in Periodontal Treatment in Uncontrolled Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT03269799
- Acronym / sponsor ID
- 2016/DT068
- Keywords
- uncontrolled type 2 diabetes mellitus, periodontitis, non surgical periodontal treatment, vitamin C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 30 Aug 2017 (estimated)
- Primary completion
- 19 Feb 2018 (estimated)
- Study completion
- 19 Aug 2018 (estimated)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Active comparator | Drug: Vitamin C 500 MG Oral Capsulevitamin C 500 mg oral capsule |
| control group | Placebo comparator | Other: placeboplacebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- uncontrolled type 2 diabetes mellitus
- periodontitis
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C 500 MG Oral Capsulenon surgical periodontal treatment+vitamin C 500 mg/day for 2 months | Drug | test group |
| placebonon surgical periodontal treatment+placebo for 2 months | Other | control group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Supanee Rassameemasmaung, DDS, M.Sc (Periodontics), Ph.D contact
Nis Okuma, DDS, MD, M.Sc (Oral Medicine) principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin C 500 MG Oral Capsule in people with Diabetes Mellitus Type 2 With Hyperglycemia and Periodontitis, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piyapat Kunsongkeit, DDS (+66870491014, pkunsongkeit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sulcus bleeding index (time frame: baseline, change from baseline sulcus bleeding index at 4 weeks, change from baseline sulcus bleeding index at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.