Change of periodontal inflammatory indicators through a 4-week weight control intervention including caloric restriction and exercise training in young Koreans
| ISRCTN | ISRCTN86753073 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86753073 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/07/2015
- Registration date
- 14/08/2015
- Last edited
- 17/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Department of Dental Hygiene
College of Medical Science
Konyang University
Daejeon
302-718
Korea, South
Study information
| Study design | Pre-post study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Prevention |
| 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 |
| Study objectives | Obesity control can influence periodontal inflammation through systemic and local change. |
| Ethics approval(s) | Ethical Committee of Konyang University Hospital, KYUH 13-89, KYUH 9-25 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | MMP-8, MMP-9, and IL-1beta in gingival crevicular fluid |
| Secondary outcome measures | Gingival index |
| Overall study start date | 01/09/2009 |
| Completion date | 01/06/2012 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 62 |
| Total final enrolment | 41 |
| Key inclusion criteria | Obese individuals (body mass index of >25) aged 20 to 29 and 13 camp trainers of the same age |
| Key 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 |
| Date of first enrolment | 01/06/2011 |
| Date of final enrolment | 28/06/2011 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
320-711
Korea, South
Sponsor information
Government
201 Gajeong-Ro
Yuseong-Gu
Daejeon
305-754
Korea, South
"ROR" |
https://ror.org/013aysd81 |
|---|
Funders
Funder type
Government
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- 한국연구재단이 창의적 연구와, National Research Foundation (South Korea), NRF
- Location
- Korea, South
Results and Publications
| Intention to publish date | 30/09/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/09/2015 | 17/12/2020 | Yes | No |
Editorial Notes
17/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
