Treatment of peri-implantitis with allografts and enamel proteins
| ISRCTN | ISRCTN15000657 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15000657 |
| Secondary identifying numbers | PS2023069 |
- Submission date
- 19/12/2023
- Registration date
- 21/12/2023
- Last edited
- 03/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Peri-implantitis is a condition that occurs in the tissues surrounding dental implants. It is characterized by inflammation of the connective tissue around the implant and loss of support bone. Allografts (transplanted tissues) have been described as a good option to reconstruct the bone defect related to peri-implantitis. Enamel matrix proteins have been previously described as an ideal material for periodontal regeneration alone or in combination with bone grafts. This study aims to measure the potential benefit of adding enamel matrix proteins to allografts in the reconstruction of bone defects due to peri-implantitis progression.
Who can participate?
Patients aged 18 years and over with implants for 1 year or more and diagnosed with advanced peri-implantitis
What does the study involve?
Participants will be randomly allocated to the test or control group during surgery. The control group will be treated with allografts alone. The test group will be treated with enamel matrix proteins and allografts. Sutures will be removed at 2 weeks after surgery. Clinical examinations will be performed at 4, 12, 24 and 48 weeks after surgery. Maintenance therapy will be carried out at 12, 24 and 48 weeks after therapy.
What are the possible benefits and risks of participating?
The benefit would be that participants' peri-implant disease will be treated and arrested. There is no additional risk of participating.
Where is the study run from?
Clínica Ortiz-Vigón (Spain)
When is the study starting and how long is it expected to run for?
September 2023 to August 2026
Who is funding the study?
Arrow Development SL (Spain)
Who is the main contact?
1. Erik Regidor, erik@ortizvigon.com
2. Alberto Ortiz-Vigón, alberto@ortizvigon.com
Contact information
Public, Scientific, Principal Investigator
Alameda Urquijo nº 2 - 7ª planta
Bilbao
48008
Spain
 ORCID ID |
0000-0002-1863-5907 |
|---|---|
| Phone | +34 (0)944 15 89 02 |
| alberto@ortizvigon.com |
Scientific
Alameda Urquijo nº 2 - 7ª planta
Bilbao
48008
Spain
| ORCID ID |
0000-0003-3338-6379 |
|---|---|
| Phone | +34 (0)944 15 89 02 |
| erik@ortizvigon.com |
Study information
| Study design | Randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Influence of enamel matrix derivatives for the treatment of peri-implant-related osseous defects with minimal flap approach: a randomized clinical trial |
| Study hypothesis | The enamel matrix derivate simultaneous to intra-bony peri-implant related defect reconstruction with allogeneic bone graft has a better outcome in terms of radiographic defect fill and re-establishing peri-implant health when comparing with using only an allogeneic bone graft with minimally invasive surgical approaches. |
| Ethics approval(s) |
Approved 19/12/2023, Basque Country local ethics committee (C/ Donostia-San Sebastián, nº 1. Vitoria-Gasteiz 01010, Vitoria, 01010, Spain; +34 (0)945 01 92 96; ceic.eeaa@euskadi.eus), ref: PS2023* |
| Condition | Peri-implantitis |
| Intervention | Study participants will be randomly allocated to the test or control group during surgery, just after completing implant decontamination procedures. The randomization sequence is determined using a block size of 4 with a 1:1 allocation. Allocation will be concealed through the use of sealed, opaque envelopes. Outcome assessors and patients will be blinded to group allocation. Surgical procedures will be performed 1 month after non-surgical periodontal treatment. On the same day of surgical therapy, an antibiotic will be administered for 7 days (amoxicillin 500 mg / 7 days / 8 hours). First, a minimally invasive surgical flap will be prepared over the implant neck. Large flaps will be avoided to minimize surgical post-operative complications such as dehiscence and loss of biomaterial. Control group: surgical reconstructive treatment of periimplantitis by means of implant surface decontamination with mechanical methods (Labrida BioClean Brush®), and osseous defect reconstruction by means of allogeneic bone graft (Straumann Allograft in particles). Test group: surgical reconstructive treatment of periimplantitis by means of implant surface decontamination with mechanical methods (Labrida BioClean Brush®), and osseous defect reconstruction by means of allogeneic bone graft (Straumann Allograft in particles) and adjunctive enamel matrix proteins (Straumann Emdogain®). Sutures will be removed 2 weeks after surgical therapy. Clinical examinations will be performed at 4,12,24 and 48 weeks after surgical therapy. Maintenance therapy will be realized at 12, 24 and 48 weeks after therapy. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Treatment success will be defined as the absence of bleeding on probing (BoP)/pus, probing pocket depth (PPD) ≤5 mm and ≤1 mm recession (measured using Periodontal Manual probe CP 15 Hu-Friedy) at 4, 12, 24 and 48 weeks after surgical therapy |
| Secondary outcome measures | Clinical assessments: One calibrated examiner will perform the assessments. The following variables will be assessed at four sites around the implant: plaque, probing pocket depth (PPD), bleeding on probing (BoP), probing attachment level (PAL) recession (REC). Keratinized mucosa (KM) will be measured in the buccal aspect of each included implant using Periodontal Manual probe CP 15 Hu-Friedy at baseline, 24 and 48 weeks. Surgical assessments: Defect configuration will be measured by one calibrated examiner in each clinical center to understand how much impact it has on clinical outcomes, measured using Periodontal Manual probe CP 15 Hu-Friedy intra-surgically. Osseous defect-related measures / recording of osseous defect characteristics: 1. Defect width (measured in mesial, distal, buccal, and palatal/lingual aspects) 2. Distance from implant neck to depth of the osseous defect (measured in mesial, distal, buccal, and palatal/lingual aspects) 3. Distance from osseous ridge to depth of the osseous defect (measured in mesial, distal, buccal, and palatal/lingual aspects) Radiographic assessments: Radiographic marginal bone level. Each included implant will be measured in mesial and distal aspects in mm with Image-J® digital software using intra-oral radiographs obtained before surgery (baseline) and at 6- and 12-month re-examinations. Analysis of radiographs will be performed by a specialist. The examiner will be blinded to treatment procedures. The assessment will include defect fill in both follow-up visits. Volumetric changes: Linear changes measured in Implant-Studio® digital software in 1, 3 and 5 mm from the mucosal peri-implant margin. Intra-oral scanning will be obtained before surgery (baseline) at 6 months and 12 months of re-examination. Analysis of STL archives will be performed by a specialist. The examiner will be blinded to treatment procedures. The assessment will include volumetric changes after matching the baseline intra-oral scanning, 6 months of intra-oral scanning and 12 months of intra-oral scanning. |
| Overall study start date | 01/09/2023 |
| Overall study end date | 01/08/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Participant inclusion criteria | 1. Age ≥18 years 2. Peri-implant bone defect ≥3 mm assessed radiographically 3. PPD ≥5 mm combined with bleeding on probing or suppuration 4. Intra-surgically, bone defect must have at least an intraosseous component of 3 mm and a width of no more than 4 mm 5. Implants ≥1 year in function |
| Participant exclusion criteria | 1. Treated for peri-implantitis during the previous 6 months 2. Intake of systemic or local antibiotics during the previous 6 months 3. Pregnant patients 4. Systemically unhealthy patients 5. Patients allergic to collagen |
| Recruitment start date | 01/01/2024 |
| Recruitment end date | 26/02/2025 |
Locations
Countries of recruitment
- Spain
Study participating centre
Bilbao
48008
Spain
Sponsor information
Research organisation
C/alameda Mazarredo 22 11B
Bilbao
48009
Spain
| Phone | +34 (0)629257524 |
|---|---|
| cursos@ortizvigon.com |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in the first months of 2026 in a high-impact journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. All the information and documents will be saved in a secure database under a highly secure password and will be supervised by the study monitor. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 19/12/2023 | No | No |
Additional files
Editorial Notes
03/03/2025: The recruitment end date was changed from 01/02/2025 to 26/02/2025.
19/12/2023: Study's existence confirmed by the Basque Country local ethics committee.
