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

NCT ID: NCT03269799

Last Updated: 2017-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-30

Study Completion Date

2018-08-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Type 2 With Hyperglycemia Periodontitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

test group

vitamin C 500 mg oral capsule

Group Type ACTIVE_COMPARATOR

Vitamin C 500 MG Oral Capsule

Intervention Type DRUG

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

control group

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

non surgical periodontal treatment+placebo for 2 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin C 500 MG Oral Capsule

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

Intervention Type DRUG

placebo

non surgical periodontal treatment+placebo for 2 months

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Supanee Rassameemasmaung

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nis Okuma, DDS, MD, M.Sc (Oral Medicine)

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Burapha University Hospital

Chon Buri, , Thailand

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Piyapat Kunsongkeit, DDS

Role: CONTACT

+66870491014

Supanee Rassameemasmaung, DDS, M.Sc (Periodontics), Ph.D

Role: CONTACT

+66867766255

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Piyapat Kunsongkeit, DDS

Role: primary

+66870491014

Pechngam Chaivanit, MD

Role: backup

+6638386554

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016/DT068

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Diabetes and Periodontal Therapy Trial
NCT00997178 COMPLETED PHASE3