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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03269799
Other study ID # 2016/DT068
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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