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

Periodontitis Clinical Trial

Official title:

The Effect of Vitamin C as an Adjunct in Periodontal Treatment in Uncontrolled Type 2 Diabetes Mellitus Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03269799
• Other study ID #: 2016/DT068
• Status: Recruiting
• Phase: Phase 2
• First received: August 28, 2017
• Last updated: August 30, 2017
• Start date: August 30, 2017
• Est. completion date: August 19, 2018

Study information

• Verified date: August 2017
• Source: Mahidol University
• Contact: Piyapat Kunsongkeit, DDS
• Phone: +66870491014
• Email: pkunsongkeit[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 19, 2018
• Est. primary completion date: February 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2 With Hyperglycemia
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Periodontitis

Intervention

Drug:
• Vitamin C 500 MG Oral Capsule
non surgical periodontal treatment+vitamin C 500 mg/day for 2 months

Other:
• placebo
non surgical periodontal treatment+placebo for 2 months

Locations

Country	Name	City	State
Thailand	Burapha University Hospital	Chon Buri

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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