Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/07/2015
Date assigned
14/08/2015
Last edited
10/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Soo-Jeong Hwang

ORCID ID

Contact details

Department of Dental Hygiene
College of Medical Science
Konyang University
Daejeon
302-718
Korea
South

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

Sponsor information

Organisation

National Research Foundation of Korea

Sponsor details

201 Gajeong-Ro
Yuseong-Gu
Daejeon
305-754
Korea
South

Sponsor type

Government

Website

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

Publication citations

Additional files

Editorial Notes