Condition category
Oral Health
Date applied
09/04/2018
Date assigned
17/04/2018
Last edited
16/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In the 21st century there is an urgent need to apply new strategies to prevent allergic diseases among children. Children with gum disease (gingivitis) often have house dust mite allergy. A strategy to eliminate the substance that causes the allergic reaction (allergen) could be dental scaling and root planning.
This study aims to investigate the beneficial effects of 6 months dental scaling and root planning at reducing the negative reaction to the dust mite allergy.

Who can participate?
Children aged 6-16 years with gingivitis and house dustmite allergy

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive a monthly session for a scaling and root planning program. Those in the second group receive standard treatment, which includes a toothpaste and monthly consultation with an experienced doctor. This lasts for 6 months. Participants in the second group can then receive the intervention program too.
Participants have a blood sample taken at the start, and after the 6 months.

What are the possible benefits and risks of participating?
Participants benefit from free dental consultation and examination, free scaling and root planning from well-experienced dentists, along with a research subject’s fee. A possible risk of participating in this study is hematoma caused by phlebotomist, since we would like to carry blood sample twice

Where is the study run from?
Faculty of Dental Medicine Universitas Airlangga - Dr. Soetomo General Hospital (Indonesia)

When is the study starting and how long is it expected to run for?
January 2017 – December 2017

Who is funding the study?
Faculty of Dental Medicine, Universitas Airlangga (Indonesia)

Who is the main contact?
Sindy Cornelia Nelwan (Scientific)
sindy-c-n@fkg.unair.ac.id

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sindy Nelwan

ORCID ID

http://orcid.org/0000-0001-7829-6524

Contact details

Jalan Mayjen Prof. Dr. Moestopo 47
Surabaya
60135
Indonesia
+62 811 346979
sindy-c-n@fkg.unair.ac.id

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20/Panke.KKE/I/2017

Study information

Scientific title

Effect of Comprehensive Six Months Dental Scaling and Root Planning To Improve Biomolecular Markers of Atopy in Gingivitis Children with House Dust Mite Allergy

Acronym

Study hypothesis

Dental scaling and root planning may improve biomolecular markers of atopy by decreasing level of IgE and IgG4 in subjects serum.

Ethics approval

Dr. Soetomo General Hospital Ethics Committee for Health Research, 20/01/2017, ref: 20/Panke.KKE/I/2017

Study design

Investigator-initiated randomized non-blinded placebo-controlled trial with two-group pretest and repeated posttest superiority-group experimental design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Periodontitis

Intervention

Participants are randomly allocated to one of two groups. Those in the intervention group receive a comprehensive 6 months dental scaling and root planning treatment program, as well as standard treatment. Scaling and Root Planning is performed by a well-experienced physician from Department of Pediatric Dentistry, Faculty of Dental Medicine Universitas Airlangga - Dr. Soetomo General Hospital, using an ultrasonic scaler. Participants attend a dental session monthly.
Those in the control group receive only standard treatment.
Standard treatment includes toothpaste containing fluoride and triclosan, and monthly consultation with a well-experienced physician.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

IgE is measured from a blood sample at baseline and 6 months

Secondary outcome measures

IgG4 is measured from a blood sample at baseline and 6 months

Overall trial start date

01/01/2017

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 6-16 years of any gender and ethnicity
2. Diagnosed with HDM allergies by positive skin-prick test
3. Diagnosed with gingivitis by >2 plaque index according to Silness-Löe criteria
4. High baseline IgE titer (>90 pg/ml), suggesting a positive childhood allergic potency
5. Understand and able to cooperate to the research protocol
6. Parents give voluntary, signed written consent in accordance with our institutional policies

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Taking any antihistamines or steroid which commonly interferes with results of skin-prick within one month
2. Previously experienced any immunotherapy procedures
3. Previously experienced dental scaling and root planning within 6 months
4. Presence of low grade fever due to infections rather than gingivitis
5. Recent blood disorders or congenital abnormalities
6. Any medical conditions that may be harmful if involved in this study

Recruitment start date

31/01/2017

Recruitment end date

28/02/2017

Locations

Countries of recruitment

Indonesia

Trial participating centre

Dr. Soetomo General Hospital
Jalan Mayjen Prof. Dr. Moestopo 6-8
Surabaya
60135
Indonesia

Trial participating centre

Universitas Airlangga
Jalan Mayjen Prof. Dr. Moestopo 47
Surabaya
60135
Indonesia

Sponsor information

Organisation

Faculty of Dental Medicine Universitas Airlangga

Sponsor details

Jalan Mayjen Prof. Dr. Moestopo 47
Surabaya
60135
Indonesia
+62315030255
admin@fkg.unair.ac.id

Sponsor type

University/education

Website

http://fkg.unair.ac.id/

Funders

Funder type

University/education

Funder name

Faculty of Dental Medicine Universitas Airlangga

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intended publication at Periodontology 2000

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Author Sindy Cornelia Nelwan (sindy-c-n@fkg.unair.ac.id)

Intention to publish date

01/06/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes