Can the results of non-surgical therapy of periodontitis be improved by the use of enamel matrix proteins?

ISRCTN	ISRCTN14654696
DOI	https://doi.org/10.1186/ISRCTN14654696

Submission date: 24/07/2020
Registration date: 29/07/2020
Last edited: 29/07/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Periodontal therapy is the treatment and prevention of gum disease. It aims to eliminate inflammation of the tissues around the affected teeth by removing bacteria from periodontal pockets below the gum line. The result is measured by the reduction of pocket depth. The non-surgical first phase of therapy may not be enough for advanced pockets and an extra surgical phase may be necessary. This study explores the possibility of improving the treatment outcomes of the non-surgical treatment phase by adding a medical device (enamel matrix derivative) to non-surgical retreatment of persisting deep pockets, thus avoiding the need for additional surgery.

Who can participate?
Adult patients with periodontitis

What does the study involve?
Two of the participant's teeth are randomly allocated to receive non-surgical retreatment either with or without use of the enamel matrix derivative (EMD). Repeated examinations are carried out over 12 months.

What are the possible benefits and risks of participating?
The possible benefits include avoidance of the need for periodontal surgery and improved diagnosis for affected teeth. There are no particular risks.

Where is the study run from?
University of Bonn (Germany)

When is the study starting and how long is it expected to run for?
July 2015 to July 2019

Who is funding the study?
Investigator initiated and funded with some support from Straumann Insitute (Switzerland)

Who is the main contact?
Prof. Søren Jepsen
jepsen@uni-bonn.de

Contact information

Prof Søren Jepsen
Scientific

Dept. of Periodontology, Operative and Preventive Dentistry
University of Bonn
Bonn
53111
Germany

ORCID ID	0000-0002-4160-5837
Phone	+49 (0)228 287 22480
Email	jepsen@uni-bonn.de

Study information

Study design	Multicenter randomized feasibility trial with split-mouth design
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Flapless application of enamel matrix derivative in periodontal retreatment: a multicenter feasibility randomized controlled trial
Study objectives	The adjunctive flapless application of EMD can lead to superior clinical outcomes compared to re-instrumentation of residual periodontal pockets alone.
Ethics approval(s)	Approved 07/08/2020, Ethics Committee of the University Hospital Bonn, Biomedizinisches Zentrum, Sigmund-Freund-Str. 25, 53105 Bonn, Germany; +49 (0)228 287 51931; ethik@uni-bonn.de), ref: 049/15-ff
Health condition(s) or problem(s) studied	Generalised periodontitis
Intervention	Adult patients presenting at re-evaluation after initial non-surgical periodontal therapy for generalised periodontitis with at least 2 teeth with residual probing pocket depths (PPD) ≥ 5 and ≤ 8 mm, with bleeding on probing (BOP). Two teeth in contralateral quadrants are randomised by coin toss to receive re-instrumentation either with (test) or without (control) adjunctive flapless administration of enamel matrix derivative (EMD). The follow-up is 12 months.
Intervention type	Device
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure	Probing pocket depth measured in mm using a periodontal probe at baseline, 6 months and 12 months
Secondary outcome measures	Bleeding on probing (yes or no) measured using a periodontal probe at baseline, 6 months and 12 months
Overall study start date	01/07/2015
Completion date	01/07/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40
Total final enrolment	44
Key inclusion criteria	1. Adult patients 2. Two residual pockets with probing depth ≥ 5 mm and ≤ 8 mm, bleeding and probing (BOP), mobility ≤ degree 1 and without furcation involvement
Key exclusion criteria	1. Full mouth plaque score (modified O'Leary et al. 1972) > 20% 2. Uncontrolled systemic disease, requiring high dose steroid therapy, radiation or other immune-suppressive therapy and history of malignant disease in the oral cavity or previous radiotherapy in the head or neck area 3. Pregnant or lactating females 4. Drug and alcohol abuse 5. Smoking > 10 cigarettes per day 6. inadequate restorative therapy or malocclusion
Date of first enrolment	01/10/2015
Date of final enrolment	01/07/2018

Locations

Countries of recruitment

Germany
Italy

Study participating centres

University of Leipzig

Leipzig
04103
Germany

Private practice

Torino
10143
Italy

University of Rome, Sapienza

Rome
00185
Italy

University of Bonn

Bonn
53111
Germany

Sponsor information

University of Bonn
University/education

Welschnonnenstrasse 17
Bonn
53111
Germany

Phone	+49 (0)228 287 22480
Email	jepsen@uni-bonn.de
Website	http://www3.uni-bonn.de/the-university
"ROR"	https://ror.org/041nas322

Funders

Funder type

Industry

Investigator initiated and funded

No information available

Financial support from Institute Straumann AG (Switzerland)

No information available

Results and Publications

Intention to publish date	31/12/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	The researchers plan to submit a manuscript for publication in a high-impact peer-reviewed journal in the second half of 2020. No additional documents have been published.
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Editorial Notes

29/07/2020: Trial's existence confirmed by Ethics Committee at the Medical Faculty of the University of Leipzig.