Plain English Summary
Background and study aims
The aim of this study was to examine the effects of a 4-week weight control program on periodontal (gum) health.
Who can participate?
Obese individuals in their twenties.
What does the study involve?
Participants stayed in the camp under surveillance for two hours of aerobic exercise, three hours of weight training, and a low salt, low fat diet. They were not allowed to have any private foods or drinks except water. We examined their dental plaque at the start and end of the study. We made no attempt to change the participants' toothbrushing method or frequency so as not to affect gum inflammation during the study.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Konyang University (South Korea).
When is the study starting and how long is it expected to run for?
September 2009 to June 2012.
Who is funding the study?
National Research Foundation of Korea (South Korea).
Who is the main contact?
Dr Soo-Jeong Hwang
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Change of MMP-8, MMP-9, and IL-1beta in gingival crevicular fluid through a 4-week weight control intervention including caloric restriction and exercise training in young Koreans
Acronym
Study hypothesis
Obesity control can influence periodontal inflammation through systemic and local change.
Ethics approval
Ethical Committee of Konyang University Hospital, KYUH 13-89, KYUH 9-25
Study design
Pre-post study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
Body mass index of >25
Intervention
The subjects stayed in the camp under surveillance for two hours of aerobic exercise, three hours of weight training, and a low salt-low fat diet (≤1,300 kcal/day). They were not allowed to have any private foods or drinks except water. We examined the dental plaque index at the baseline and final state to serve as a proxy for the maintenance of the subjects' habitual oral health behavior. We made no attempt to change the subjects' toothbrushing method or frequency so as not to affect gingival inflammation during the program. Smoking was not prohibited to maintain the other conditions as confounding factors except weight control.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
MMP-8, MMP-9, and IL-1beta in gingival crevicular fluid
Secondary outcome measures
Gingival index
Overall trial start date
01/09/2009
Overall trial end date
01/06/2012
Reason abandoned
Eligibility
Participant inclusion criteria
Obese individuals (body mass index of >25) aged 20 to 29 and 13 camp trainers of the same age
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
62
Participant exclusion criteria
1. Systemic disease exclusive of obesity
2. Use of steroidal or non-steroidal anti-inflammatory drugs or antibiotics in the last three months or during the program
3. Use of mouthwash in the last three months or during the program
4. Need of dental or medical treatment during the program
5. Fewer than 24 teeth
6. Sites with probing periodontal pocket depth (PD) > 3.5 mm
7. Self-directed dropout during the course of the weight-control program
Recruitment start date
01/06/2011
Recruitment end date
28/06/2011
Locations
Countries of recruitment
Korea, South
Trial participating centre
Konyang University
Nonsan
320-711
Korea, South
Funders
Funder type
Government
Funder name
National Research Foundation of Korea
Alternative name(s)
NRF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Korea, South
Results and Publications
Publication and dissemination plan
Intention to publish date
30/09/2015
Participant level data
Available on request
Results - basic reporting
Publication summary