Regenerative Surgical Treatment of Peri-implant Defects
NCT ID: NCT04440241
Last Updated: 2021-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
44 participants
INTERVENTIONAL
2021-04-01
2022-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Nevertheless, there appears to be no consensus on treatment standards for the management of peri-implant diseases. Also, the significant variation in the empirical use of the available therapeutic modalities seems to result in moderately effective treatment outcomes. Animal and human case series-studies have shown improved outcomes when using a submerged healing approach. However, there seems to be no randomized controlled clinical studies comparing submerged/non-submerged healing efficacy for the treatment of peri-implantitis. Since current modalities for the treatment of peri-implantitis seem to result inmoderately effective outcomes, there is an urgency to investigate treatment strategies that will result in improved patient's benefits in terms of health.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Guided Bone Regeneration of Peri-implant Defects Comparing Submerged Versus Non-submerged Healing
NCT03900741
Preventive Maintenance Therapy on Peri-implant Diseases
NCT02789306
Submerged Vs Non-Submerged Guided Bone Regeneration Simultaneous to Implant Placement.
NCT06695338
Flapless Surgical Treatment of Peri-implantitis
NCT06093360
Compliance and Cumulative Interceptive Rate After Therapy of Peri-implantitis
NCT05772078
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Test group: submerged healing or Control group: non-submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.
The primary aim of this study is to evaluate whether submerged healing of implants willsignificantly improve the changes in marginal bone levels measured on X-rays 12months post-treatment compared to a non-submerged healing approach for the treatment of peri-implantitis.
Secondary aims include changes in clinical attachment levels, changes in probing pocket depth, recession, keratinized tissue, occurrence of bleeding on probing, suppuration on probing (PUS), marginal gingival recession (REC), full mouth plaque score (FMPS), full mouth bleeding score (FMBS), type of peri-implant bone defect, frequency and type of complications and implant loss.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Test group
submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.
regenerative treatment periimplantitis
Full thickness buccal and lingual flaps will be performed. After debridement of the defect using hand and ultrasonic instruments and implant surface decontamination using titanium brushes (TiBrush®) and saline Regenerative treatment will be performed only in the intrabony component of type 1 peri-implant defects. Guided bone regeneration using a bone substitute (Bio-oss®) and a resorbable membrane (bio-gide®) will be performed in the intrabony and dehiscenses areas of the defect.
The surgeon will be blinded to the assignment of treatment until it is time to close the flaps.
Control group
non submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.
regenerative treatment periimplantitis
Full thickness buccal and lingual flaps will be performed. After debridement of the defect using hand and ultrasonic instruments and implant surface decontamination using titanium brushes (TiBrush®) and saline Regenerative treatment will be performed only in the intrabony component of type 1 peri-implant defects. Guided bone regeneration using a bone substitute (Bio-oss®) and a resorbable membrane (bio-gide®) will be performed in the intrabony and dehiscenses areas of the defect.
The surgeon will be blinded to the assignment of treatment until it is time to close the flaps.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
regenerative treatment periimplantitis
Full thickness buccal and lingual flaps will be performed. After debridement of the defect using hand and ultrasonic instruments and implant surface decontamination using titanium brushes (TiBrush®) and saline Regenerative treatment will be performed only in the intrabony component of type 1 peri-implant defects. Guided bone regeneration using a bone substitute (Bio-oss®) and a resorbable membrane (bio-gide®) will be performed in the intrabony and dehiscenses areas of the defect.
The surgeon will be blinded to the assignment of treatment until it is time to close the flaps.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Systemically healthy patients.
* Presence of at least 1 implant diagnosed with peri-implantitis (peri-implant probing pocket depth ≥6 mm in at least 1 aspect of the implant with bleeding and/or suppuration on probing and radiographically documented marginal bone loss ≥3mm) according to Renvert et al. (2018), after non-surgical therapy of periimplantitis, and a 4mm deep intrabony component.
* Absence of mobility of the implants.
* Individual implant-supported crown or partial fixed implant supported restoration (removable prosthesis will be excluded).
* Patient's smoking ≤ 10 cigarettes/day.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Osteology Foundation
OTHER
University of Santiago de Compostela
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Juan Blanco Carrión
Principal investigator - Juan Blanco Carrión
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Santiago Mareque
Role: STUDY_DIRECTOR
University of Santiago de Compostela
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Master Periodoncia. Facultad odontología
Santiago de Compostela, A Coruña, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Schwarz F, Herten M, Sager M, Bieling K, Sculean A, Becker J. Comparison of naturally occurring and ligature-induced peri-implantitis bone defects in humans and dogs. Clin Oral Implants Res. 2007 Apr;18(2):161-70. doi: 10.1111/j.1600-0501.2006.01320.x.
Schwarz F, Sahm N, Schwarz K, Becker J. Impact of defect configuration on the clinical outcome following surgical regenerative therapy of peri-implantitis. J Clin Periodontol. 2010 May;37(5):449-55. doi: 10.1111/j.1600-051X.2010.01540.x. Epub 2010 Mar 24.
Roccuzzo M, Bonino F, Bonino L, Dalmasso P. Surgical therapy of peri-implantitis lesions by means of a bovine-derived xenograft: comparative results of a prospective study on two different implant surfaces. J Clin Periodontol. 2011 Aug;38(8):738-45. doi: 10.1111/j.1600-051X.2011.01742.x. Epub 2011 Jun 2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REGT_CT_19
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.