Condition category
Oral Health
Date applied
20/05/2019
Date assigned
03/06/2019
Last edited
04/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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?
The study has started at 28-05-2019 and we need to treat 40 patients and follow the evolution for 12 months. We have estimated to end the trial around 01/06/2021.

Who is funding the study?
Periocentrum Bilbao.

Who is the main contact?
Erik Regidor
Erik@ortizvigon.com

Trial website

N/A

Contact information

Type

Scientific

Primary contact

Mr Erik Regidor Correa

ORCID ID

http://orcid.org/0000-0003-3338-6379

Contact details

C/ ALAMEDA URQUIJO 2 7º PLANTA
Bilbao
48008
Spain
662025988
erik@ortizvigon.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2019012

Study information

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

Acronym

RPT

Study hypothesis

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

Approval pending, the 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/).

Study design

Multicenter randomized controlled clinical trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

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 trial start date

01/02/2019

Overall trial end date

01/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 patients divided in two groups being 20 patients per group

Participant exclusion criteria

1. Has iabetes 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.

Recruitment start date

01/05/2019

Recruitment end date

01/05/2020

Locations

Countries of recruitment

Spain

Trial participating centre

PerioCentrum Bilbao
Alameda Urquijo street 2, 7th floor
Bilbao
48008
Spain

Trial participating centre

University of basque country
Sarriena Borough
Lejona
48920
Spain

Sponsor information

Organisation

Periocentrum Bilbao

Sponsor details

C/ alameda urquijo 2 7º planta
Bilbao
48008
Spain
+34 662 025 988
erik@ortizvigon.com

Sponsor type

Research organisation

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Periocentrum Bilbao

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

When we reach the total number of patients treated we will follow them for 12months. After we will prepare the manuscript and publish it before finishing 2021 in a high impact journal.

IPD sharing statement: the datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/11/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.