Condition category
Oral Health
Date applied
24/07/2020
Date assigned
29/07/2020
Last edited
29/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Søren Jepsen

ORCID ID

http://orcid.org/0000-0002-4160-5837

Contact details

Dept. of Periodontology
Operative and Preventive Dentistry
University of Bonn
Bonn
53111
Germany
+49 (0)228 287 22480
jepsen@uni-bonn.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Flapless application of enamel matrix derivative in periodontal retreatment: a multicenter feasibility randomized controlled trial

Acronym

Study hypothesis

The adjunctive flapless application of EMD can lead to superior clinical outcomes compared to re-instrumentation of residual periodontal pockets alone.

Ethics approval

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

Study design

Multicenter randomized feasibility trial with split-mouth design

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 contact details to request a participant information sheet

Condition

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

Phase

Not Applicable

Drug names

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 trial start date

01/07/2015

Overall trial end date

01/07/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Total final enrolment

44

Participant 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

Recruitment start date

01/10/2015

Recruitment end date

01/07/2018

Locations

Countries of recruitment

Germany, Italy

Trial participating centre

University of Leipzig
Leipzig
04103
Germany

Trial participating centre

Private practice
Torino
10143
Italy

Trial participating centre

University of Rome, Sapienza
Rome
00185
Italy

Trial participating centre

University of Bonn
Bonn
53111
Germany

Sponsor information

Organisation

University of Bonn

Sponsor details

Welschnonnenstrasse 17
Bonn
53111
Germany
+49 (0)228 287 22480
jepsen@uni-bonn.de

Sponsor type

University/education

Website

http://www3.uni-bonn.de/the-university

Funders

Funder type

Industry

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Financial support from Institute Straumann AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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