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

Phase 2

• Conditions: Periodontitis; Diabetes Mellitus Type 2 With Hyperglycemia
• Interventions: Other: placebo; Drug: Vitamin C 500 MG Oral Capsule

• Registration Number: NCT03269799
• Lead Sponsor: Mahidol University

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-28
• Study Start: 2017-08-30
• Study First Submitted QC: 2017-08-30
• Last Update Submitted: 2017-08-30
• Study First Posted: 2017-09-01
• Last Update Posted: 2017-09-01
• Primary Completion: 2018-02-19
• Study Completion: 2018-08-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• uncontrolled type 2 diabetes mellitus
• periodontitis

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	placebo	placebo
test group	Vitamin C 500 MG Oral Capsule	vitamin C 500 mg oral capsule

Primary Outcome Measures

Name	Time	Method
sulcus bleeding index	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

Trial Locations

Locations (1)

Burapha University Hospital; 🇹🇭 Chon Buri, Thailand