Reconstructive surgical therapy of peri-implantitis bone defects
| ISRCTN | ISRCTN67095066 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67095066 |
| Secondary identifying numbers | 2019012 |
- Submission date
- 20/05/2019
- Registration date
- 03/06/2019
- Last edited
- 17/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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. In a recent systematic review, a 22% prevalence of peri-implantitis has been described. If the literature is analyzed, it can be verified how different percentages of prevalence are reported due to the different definition of this pathological condition depending on the study analyzed, being from 1% to 47%. In addition, it has been suggested that this bone loss is time-dependent and that the follow-up time of the different studies can also affect the percentage of prevalence described. The potential benefit of using bone substitutes / biological agents in reconstructive procedures for the treatment of periimplantitis remains undefined for the time being due to the existence of few clinical studies with very heterogeneous designs and different follow-up times. Concerning the material that should be used during the reconstructive procedure, the existing literature is heterogeneous. Several studies evaluate the effectiveness of material without comparing with any control group, while others either compare the use of a material with the performance of only mechanical debridement or with the use of a different material. For this reason, it is difficult to draw solid conclusions about the ideal material.
Who can participate?
1. Age ≥ 18 years
2. Peri-implant bone defect ≥ 3mm assessed radiographically
3. PPD ≥ 5mm combined with bleeding on probing or supuration
4. Intra-surgically, bone defect must have at least a intraosseous component of 3mm and a width of no more than 4mm
5. implants ≥ 1 year in function
What does the study involve?
The test group will be treated with xenograft cover with a resorbable collagen membrane and the control group will be treated with xenograft only.
What are the possible benefits and risks of participating?
The benefit is the reconstruction of the peri-implant bone previously lost and arrest the peri-implant pathology.
The risk is not being able to stop the disease.
Where is the study run from?
1. Periocentrum Bilbao. Bilbao. 48008. Spain.
2. Periodontology postgraduate program at the University of Basque Country Lejona, 48940 Spain.
When is the study starting and how long is it expected to run for?
February 2019 to February 2022
Who is funding the study?
Periocentrum Bilbao.
Who is the main contact?
Erik Regidor
Erik@ortizvigon.com
Contact information
Scientific
C/ ALAMEDA URQUIJO 2 7º PLANTA
Bilbao
48008
Spain
 ORCID ID |
0000-0003-3338-6379 |
|---|---|
| Phone | 662025988 |
| erik@ortizvigon.com |
Study information
| Study design | Multicenter randomized controlled clinical trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Reconstructive surgical therapy of peri-implantitis-related bone defects: Application of a bovine-derived bone xenograft with or without a resorbable collagen membrane. Multicenter controlled randomized clinical trial |
| Study acronym | RPT |
| Study objectives | The use of a resorbable membrane in combination with a xenograft of bovine origin offers an additional benefit in the treatment of peri-implant bone defects compared to the use of the xenograft alone. |
| Ethics approval(s) | Approved 29/04/2019, Ethical Committee of the Basque Country (CEIm de Euskadi [Comité de Ética de la Investigación Clínica con medicamentos] Farmaziako Zuzendaritza / Dirección de Farmacia. Osasun saila / Departamento de Salud. Eusko Jaurlaritza / Gobierno Vasco C/ Donostia-San Sebastián, 1 – 01010 Vitoria-Gasteiz; ceic.eeaa@euskadi.eus; 945 01 64 59; http://www.euskadi.eus/comite-etico-investigacion-clinica/), ref: PS2019012. |
| Health condition(s) or problem(s) studied | Intraosseous peri-implant defects |
| Intervention | The test group will be treated with xenograft cover with a resorbable collagen membrane. Control group will be treated with xenograft only. The intervention will we realized in a single session and the follow-up will be 12 months after the surgical procedure. Randomization will be carried out by means of 5 blocks by a sequence generated by the computer. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Probing depth (PS) is measured in 6 locations per implant. It consists of probing from the margin of the peri-implant mucosa to the most apical part of the peri-implant defect at baseline, at 6 months and at 12 months. |
| Secondary outcome measures | 1. Filling of the radiographic defect is measured using intraoral radiographs of the implant at baseline, 6 months and 12 months. The defect that is appreciated in the initial radiography with the filling in the following ones will be compared. 2. Mucosal recession is measured at one vestibular point of each implant. Measured from the apical margin of the implant-supported restoration to the margin of the peri-implant mucosa at baseline, at 6 months and at 12 months. 3. Bleeding on probing is measured in 6 locations per implant in basal at 6 months and 12 months. 4. Plaque control is measured in 6 locations per implant in basal at 6 months and 12 months. 5. Presence of complications is measured using membrane exposure at healing period. It will be checked if there is primary closure of the lesion or if there is membrane exposure. 6. Intervention time. Is measured by a chronometer since the first incision until the last suture. 7. Patient satisfaction and morbidity are measured using a visual analogic scale at 2 weeks, 6 months and 12 months to know the postoperative morbidity and perception and satisfaction with the procedure. 8. Volumetric changes are measured using an intraoral scanner and a digital computer program that superimposes an initial scanner with the posterior ones to see the volumetric changes at baseline, at 6 months and 12 months. |
| Overall study start date | 01/02/2019 |
| Completion date | 28/02/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 patients divided in two groups being 20 patients per group |
| Total final enrolment | 43 |
| Key inclusion criteria | 1. Show radiographically peri-implant intraosseous defects of at least 3mm depth. 2. Depth of clinical probing ≥ 5mm with bleeding and/or suppuration. 3. Intra-surgically, the infra-osseous defect must have at least one intraosseous component of 3mm and a width of no more than 4mm. 4. The implant to be treated must have been in function for at least 12 months. |
| Key exclusion criteria | 1. Has diabetes mellitus, hyperparathyroidism and/or osteomalacia. 2. Treated with corticosteroids. 3. Medicated with drugs that induce gingival hyperplasia. 4. Allergic to penicillin or who have taken antibiotics in the last 6 months. 5. Pregnant or breast-feeding patients. 6. Patients with osteoporosis. 7. Impossibility of stabilizing bovine bone with collagen or primary closure of soft tissue. 8. Patients with collagen allergy. 9. Patients treated with radiotherapy. |
| Date of first enrolment | 01/07/2019 |
| Date of final enrolment | 28/01/2021 |
Locations
Countries of recruitment
- Spain
Study participating centres
Bilbao
48008
Spain
Lejona
48920
Spain
Sponsor information
Research organisation
C/ alameda urquijo 2 7º planta
Bilbao
48008
Spain
| Phone | +34 662 025 988 |
|---|---|
| erik@ortizvigon.com |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/10/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | When we reach the total number of patients treated we will follow them for 12 months. After we will prepare the manuscript and publish it before finishing 2021 in a high impact journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 03/06/2019 | 04/06/2019 | No | No | |
| Results article | 19/02/2023 | 17/03/2023 | Yes | No |
Additional files
- ISRCTN67095066_protocol_3Jun19.pdf
- Uploaded 04/06/2019
Editorial Notes
17/03/2023: Publication reference added.
14/11/2022: The recruitment start date was changed from 01/05/2019 to 01/07/2019.
15/02/2022: The final enrolment number has been changed from 42 to 43.
20/01/2022: The overall trial end date was changed from 28/01/2022 to 28/02/2022. The total final enrolment number was changed from 40 to 42.
28/01/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/01/2021 to 28/01/2021.
2. The overall trial end date was changed from 01/01/2022 to 28/01/2022.
3. The intention to publish date was changed from 01/04/2022 to 01/10/2022.
4. The total final enrolment number was added.
09/12/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/12/2020 to 01/01/2021.
2. The overall trial end date was changed from 01/06/2021 to 01/01/2022.
3. The intention to publish date was changed from 01/11/2021 to 01/04/2022.
02/06/2020: The recruitment end date was changed from 01/05/2020 to 01/12/2020.
09/07/2019: The ethics approval date and reference number were added.
04/06/2019: The protocol file was uploaded (not peer reviewed).
03/06/2019: Trial's existence confirmed by the Ethical Committee of the Basque Country.
