Vitamin C as an Adjunct in Periodontal Treatment in Type... | NCT03269799

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

NCT03269799

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Sep 1, 2017Actual

Enrollment

30Estimated

Phase

Phase 2

Conditions

Diabetes Mellitus Type 2 With Hyperglycemia
Periodontitis

Interventions

Vitamin C 500 MG Oral Capsule
placebo

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2017Estimated

Primary Completion Date

Feb 19, 2018Estimated

Completion Date

Aug 19, 2018Estimated

First Submitted Date

Aug 28, 2017

First Submission Date that Met QC Criteria

Aug 30, 2017

First Posted Date

Sep 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2017

Last Update Posted Date

Sep 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
test group	Active Comparator	vitamin C 500 mg oral capsule	Drug: Vitamin C 500 MG Oral Capsule
control group	Placebo Comparator	placebo	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin C 500 MG Oral Capsule	Drug	non surgical periodontal treatment+vitamin C 500 mg/day for 2 months	test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Piyapat Kunsongkeit, DDS	Contact	+66870491014		pkunsongkeit@gmail.com
Supanee Rassameemasmaung, DDS, M.Sc (Periodontics), Ph.D	Contact	+66867766255		supanee.ras@mahidol.ac.th

Overall Officials

Name	Affiliation	Role
Nis Okuma, DDS, MD, M.Sc (Oral Medicine)	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Burapha University Hospital	Recruiting	Chon Buri		20130	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010518	Periodontitis

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001205	Ascorbic Acid

Ancestor Terms

ID	Term
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided