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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of Bonn |
| Funders | Investigator initiated and funded, Financial support from Institute Straumann AG (Switzerland) |
- 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
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
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 |
| jepsen@uni-bonn.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter randomized feasibility trial with split-mouth design |
| Secondary study design | Randomised controlled trial |
| Study type | 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Probing pocket depth measured in mm using a periodontal probe at baseline, 6 months and 12 months |
| Key secondary outcome measure(s) |
Bleeding on probing (yes or no) measured using a periodontal probe at baseline, 6 months and 12 months |
| Completion date | 01/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
04103
Germany
10143
Italy
00185
Italy
53111
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/07/2020: Trial's existence confirmed by Ethics Committee at the Medical Faculty of the University of Leipzig.
