Apical access for treatment of peri-implantitis
| ISRCTN | ISRCTN16923588 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16923588 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Arrow Development S.L. |
| Funder | Arrow Development SL |
- Submission date
- 12/11/2023
- Registration date
- 14/11/2023
- Last edited
- 14/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Periimplantitis is a pathological condition that occurs in the tissues surrounding dental implants. It is characterized by inflammation of the peri-implant connective tissue and loss of progressive support bone. The use of membranes has shown superior results to using bone grafts alone in terms go bone gain around implants prior to or simultaneous to their placement. Nonetheless, around implants with infectious diseases, the use of membranes has been associated with a higher risk of membrane and bone graft particle exposure after wound dehiscence or separation of the wound edges, due to a failure of proper wound healing during the healing period. Apical buccal access flap has been described as a surgical procedure with a low rate of complications such as soft tissue dehiscence and exposure of membrane and/or bone substitute particles. The overall objective of this study is to evaluate the clinical effects of an apical buccal access flap combined with a xenogeneic bone graft and a resorbable collagen membrane in the surgical reconstructive therapy of peri-implantitis.
Who can participate?
Patients with implants ≥ 1 year in function and diagnosed with advanced peri-implantitis at ≥ 1 implant
What does the study involve?
The study involves a new surgical design for the treatment of peri-implantitis-related intra-bony defects due to peri-implantitis progression. The hypothesis is that this new surgical design will improve patient perception and will reduce the appearance of complications such as soft tissue dehiscences, and exposure of membranes and bone particles.
What are the possible benefits and risks of participating?
The benefit of participating will be that the participant's peri-implant disease will be treated and arrested. There is no additional risk of participating.
Where is the study run from?
Clínica Ortiz-Vigón dental office (Spain)
When is the study starting and how long is it expected to run for?
May 2023 to December 2025
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
Urquijo 2
Bilbao
48008
Spain
 ORCID ID |
0000-0003-3338-6379 |
|---|---|
| Phone | +34 662025988 |
| erik@ortizvigon.com |
Principal investigator
Urquijo 2
Bilbao
48009
Spain
| ORCID ID |
0000-0002-1863-5907 |
|---|---|
| Phone | +34 662025988 |
| alberto@ortizvigon.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Apical buccal access flap for the reconstructive therapy of peri-implantitis-associated intra-bony defects- prospective cohort study |
| Study objectives | The use of apical buccal access flap (surgical design) combined with a xenograft and resorbable collagen membrane offers an additional benefit in the reconstructive surgical therapy of peri-implant related bony defects in terms of bone gain and reduction of complications, increasing patient satisfaction. |
| Ethics approval(s) |
Approved 21/09/2023, Basque Country Local Ethics Committee (Donostia-San Sebastián, 1, Vitoria, 01010, Spain; +34 945 01 80 00; ceic.eeaa@euskadi.eus), ref: PS2023043 |
| Health condition(s) or problem(s) studied | Advanced peri-implantitis |
| Intervention | The project will be conducted as a prospective cohort study of 1-year duration in 1 clinical center. 20 systemically healthy patients with implants ≥ 1 year in function and diagnosed with advanced peri-implantitis at ≥ 1 implant will be enrolled. Surgical procedures will be performed one month after non-surgical periodontal treatment. On the same day of surgical therapy, an antibiotic will be administered for 7 days (amoxicillin 500mg / 7 days / 8 hours). The first apical buccal access flap will be performed. The implant surface will be decontaminated with Labrida® Chitosan Brush and an intra-bony component of the defect will be filled with a xenogeneic bone graft. Finally, a resorbable collagen membrane will be used to cover all the bone grafts and primary wound closure will be obtained with suture. 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(s) |
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 a periodontal manual probe CP 15 Hu-Friedy at 4, 12, 24 and 48 weeks after surgical therapy |
| Key secondary outcome measure(s) |
Clinical assessments: |
| Completion date | 01/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. Aged ≥ 18 years old 2. Peri-implant bone defect ≥ 3mm assessed radiographically 3. PPD ≥ 5mm combined with bleeding on probing or suppuration 4. Intra-surgically, the bone defect must have at least an intraosseous component of 3mm and a width of no more than 4mm implants ≥ 1 year in function |
| Key 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 |
| Date of first enrolment | 01/12/2023 |
| Date of final enrolment | 01/12/2024 |
Locations
Countries of recruitment
- Spain
Study participating centre
Bilbao
48008
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Erik Regidor, erik@ortizvigon.com when the study is finished and during the manuscript submission. |
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 |
| Protocol file | 14/11/2023 | No | No |
Additional files
- 44578_Protocol.pdf
- Protocol file
Editorial Notes
14/11/2023: Study's existence confirmed by the Basque Country Local Ethics Committee (Spain).
