Clinical trial NCT05282667: Reconstructive Management of Peri-implantitis
Official title: Significance of Barrier Membrane in the Reconstructive Management of Peri-implantitis: A RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resolution of Pathologic Process
Lead sponsor: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief summary: With the growing burden of peri-implantitis around the globe, interest has flourished on the management of this pathology. Nevertheless, lack of consensus exists in the pursuit of a predictable therapy. Different therapeutic modalities have been advocated. Non-surgical therapy as a sole modality is often insufficient to resolve inflammation. Surgical interventions have demonstrated more favorable outcomes. Amongst these, evidence supported the application of resective, reconstructive, or combined approaches to limit progressive bone loss and achieve soft tissue health. Nevertheless, up to date, the most suitable modality remains unknown and the decision-making process derives from the understanding acquired from the management of periodontitis.

One critical element regarded to successfully resolve peri-implantitis is to efficiently detoxify the contaminated implant surface. Mechanical, pharmacological and chemical strategies have been proposed to eliminate bacterial plaque and remnants from the implant surface. However, evidence has not demonstrated superiority of a given detoxification agent/strategy.

In this sense, the significance of barrier membranes is not yet well understood. Roos-Jansaker in 2014 showed that the additional use of barrier membranes did not improve the outcome. Nevertheless, since then this subject has not been a matter of research.

Detailed description: The effect of barrier membrane in the reconstructive management of peri-implantitis will be tested at 12-month follow-up

Eligibility criteria: Inclusion Criteria:

* Non-smokers
* No use of antibiotics recently
* No metabolic disorder
* Infra-osseous or combined peri-implantitis defect

Exclusion Criteria:

* Smokers
* Pregnant
* Metabolic disorders that affect bone healing
* Supra-crestal defects

Primary outcomes:
measure: Changes in clinical parameters
timeFrame: 12 months
Secondary outcomes:
measure: Changes in Bone level
timeFrame: 12-month follow-up
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Clinica CICOM
Study officials:
References:
citation: Monje A, Pons R, Roccuzzo A, Salvi GE, Nart J. Reconstructive therapy for the management of peri-implantitis via submerged guided bone regeneration: A prospective case series. Clin Implant Dent Relat Res. 2020 Jun;22(3):342-350. doi: 10.1111/cid.12913. Epub 2020 May 14.
citation: Monje A, Pons R, Amerio E, Wang HL, Nart J. Resolution of peri-implantitis by means of implantoplasty as adjunct to surgical therapy: A retrospective study. J Periodontol. 2022 Jan;93(1):110-122. doi: 10.1002/JPER.21-0103. Epub 2021 May 15.