Vitamin C as an Adjunct in Periodontal Treatment in Type 2 Diabetes Mellitus Patients
The Effect of Vitamin C as an Adjunct in Periodontal Treatment in Uncontrolled Type 2 Diabetes Mellitus Patients
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2017
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2017
CompletedStudy Start
First participant enrolled
August 30, 2017
CompletedFirst Posted
Study publicly available on registry
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2018
CompletedSeptember 1, 2017
August 1, 2017
6 months
August 28, 2017
August 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sulcus bleeding index
bleeding upon probing of gingival sulcus from the most severe periodontitis tooth
baseline, change from baseline sulcus bleeding index at 4 weeks, change from baseline sulcus bleeding index at 8 weeks
Study Arms (2)
test group
ACTIVE COMPARATORvitamin C 500 mg oral capsule
control group
PLACEBO COMPARATORplacebo
Interventions
non surgical periodontal treatment+vitamin C 500 mg/day for 2 months
Eligibility Criteria
You may qualify if:
- uncontrolled type 2 diabetes mellitus
- periodontitis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Burapha University Hospital
Chon Buri, 20130, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nis Okuma, DDS, MD, M.Sc (Oral Medicine)
Mahidol University
Central Study Contacts
Supanee Rassameemasmaung, DDS, M.Sc (Periodontics), Ph.D
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 28, 2017
First Posted
September 1, 2017
Study Start
August 30, 2017
Primary Completion
February 19, 2018
Study Completion
August 19, 2018
Last Updated
September 1, 2017
Record last verified: 2017-08