Condition category
Oral Health
Date applied
22/02/2016
Date assigned
22/02/2016
Last edited
22/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Periodontitis is a serious gum infection that damages the soft tissue and bone that supports the teeth (periodontium). It is caused by bacteria which attach to the teeth at the gum line and cause an infection. Over time, the bacterial infection causes inflammation (swelling) and pain in the mouth, eventually leading to tooth loss if it is not properly treated. The condition is largely preventable by good oral hygiene (brushing and flossing morning and night) however if the periodontitis is particularly advanced then more drastic treatment is necessary. Emdogain is a product which was introduced in 1996 to treat gum disease, usually in combination with dental surgery. It is an enamel matric derivative (EMD) which means that it is able to stimulate the soft tissues and bone surrounding the teeth the regrow (regeneration). Several studies have shown that Emdogain can be very effective an promoting regeneration of the periodontium, however the way that this works is still not fully understood. The aim of this study is to assess the effects of treatment using Emdogain on cytokine (chemicals naturally produced by the body which help wound healing) levels in the pockets around the teeth.

Who can participate?
Non-smoking adults aged between 25 and 75 who are suffering from gum disease with two teeth in different areas of the mouth requiring surgical treatment.

What does the study involve?
All participants have two teeth in different parts of their mouth which require surgical treatment. For both teeth, the gum is cut open to expose the bone so that a deep-cleaning can be completed to remove the bacteria and plaque that is causing the infection. The two teeth in each participant’s mouth are randomly allocated to two groups, in which those in the first group undergo the open flap debridement only and those in the second group have 0.3ml of Emdogain applied to the tooth root surface and the affected part of the periodontium at the end of the open flap debridement procedure. A sample of ginvival fluid (fluid around the gum line) is taken from the top of each tooth at the start of the study and then again after 7 and 14 days to measure levels of cytokines.

What are the possible benefits and risks of participating?
There is a possibility that the areas treated using Emdogain may help to promote tissue regeneration following surgery. There is a small risk of discomfort and tenderness following surgery, however this is usual after this type of procedure.

Where is the study run from?
Bjerke Tannmedisin (Norway)

When is the study starting and how long is it expected to run for?
January 2014 to September 2014

Who is funding the study?
1. Norwegian Research Council (Norway)
2. Institute of Clinical Dentistry, University of Oslo (Norway)

Who is the main contact?
1. Professor Janne Elin Reseland (scientific)
2. Dr Oscar Villa (scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Prof Janne Elin Reseland

ORCID ID

Contact details

Institute of Clinical Dentistry
Department of Biomaterials
Geitmyrsveien 71
Oslo
0455
Norway

Type

Scientific

Additional contact

Dr Oscar Villa

ORCID ID

Contact details

Institute of Clinical Dentistry
Department of Biomaterials
Geitmyrsveien 71
Oslo
0455
Norway

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2013/1821/REK sør-øst C

Study information

Scientific title

Enamel matrix derivatives in periodontal regenerative surgery modulates cytokine profiles: A randomised controlled clinical trial

Acronym

Study hypothesis

Null hypothesis:
The enamel matrix derivative does not differentiallly induce cytokine profiles in vitro and clinically compared to the control group.

Ethics approval

Norwegian Medicines Agency and the Regional Committees for Medical and Health Research Ethics, 20/11/2013, ref: 2013/1821/REK sør-øst C

Study design

Single-centre randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Generalized severe chronic periodontitis

Intervention

All participants present two teeth in different regions of the mouth that require surgical treatment. One of these teeth is randomly selected to undergo open flap debridement with the application of Emdogain (intervention) and the other tooth undergo the same surgical procedure but without the application of Emdogain. The dosage given is 0.3ml of Emdogain to a concentration of 30 mg ml-1, applied one time at the time of the surgery onto the root surface and the periodontal defect.

The follow-up period for both the control and intervention teeth is two weeks, with samples of gingival fluid tested for cytokines at 7 and 14 days.

Intervention type

Drug

Phase

Phase IV

Drug names

Enamel matrix derivative

Primary outcome measures

Cytokine levels in gingival fluid are measured using the Luminex-200 system (multiplex bead-based immunoassay) at baseline, 7 and 14 days postoperatively.

Secondary outcome measures

N/A

Overall trial start date

01/01/2014

Overall trial end date

05/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 25 and 75 years
2. Non-smoking
3. No use of antibiotics over the previous 6 months prior to treatment
4. The presence of one pair of interproximal sites with probing pocket depth (PPD) of 6 mm or more, horizontal and/or vertical bone loss as demonstrated by the probing measurement and radiographic assessments following the initial phase of periodontal treatment
5. Experimental teeth must either have a vital pulp or, if subjected to root canal treatment, be asymptomatic, and without technical remarks
6. Prior to the start of the trial, the patients will give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15

Participant exclusion criteria

1. Patients with a systemic condition like diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, bone metabolic disease, radiation or immune-suppressive therapy
2. Patients with acute infectious lesions in the area of intended therapy

Recruitment start date

01/01/2014

Recruitment end date

15/04/2014

Locations

Countries of recruitment

Norway

Trial participating centre

Bjerke Tannmedisin
Trondheimsveien 275
Oslo
N-0589
Norway

Sponsor information

Organisation

Regional Committees for Medical and Health Research Ethics (REK)

Sponsor details

Gullhaugveien 1-3
Oslo
0484
Norway

Sponsor type

Other

Website

http://helseforskning.etikkom.no

Funders

Funder type

Government

Funder name

Norwegian Research Council (Norges Forskningsråd)

Alternative name(s)

Research Council of Norway, Forskningsrådet, Norwegian Research Council

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Norway

Funder name

Institute of Clinical Dentistry, University of Oslo

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in the journal Scientific Reports.

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes