Clinical trial NCT04440241: Regenerative Surgical Treatment of Peri-implant Defects
Official title: Regenerative Surgical Treatment of Peri-implant Defects. Submerged Versus Not Submerged
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Implant Site Pocket Infection
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: Osteology Foundation
First posted: 2020-06-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Test group: submerged healing Control group: non-submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.
Primary purpose: TREATMENT

Brief summary: Does submerged healing of implants improve clinical and radiologic outcomes for the treatment of peri-implantitis? A number of recent systematic reviews have shown that the prevalence of periimplantitisin the population is high.

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.

Detailed description: The present study will be double-blinded randomized controlled clinical trial. Patients requiring surgical treatment of peri-implantitis after non-surgical therapy will beassigned to either:

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years.
* 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:

* Non-removable prostheses

Primary outcomes:
measure: Changes marginal bone level
timeFrame: baseline, 6 and 12 months
Secondary outcomes:
measure: Changes Probing pocket depth
timeFrame: baseline, 6 and 12 months
measure: Changes Clinical attachment level
timeFrame: baseline, 6 and 12 months
measure: Change Reccesion
timeFrame: baseline, 6 and 12 months
measure: Change Keratinized mucosa
timeFrame: baseline, 6 and 12 months
measure: Change blending on probing
timeFrame: baseline, 6 and 12 months
measure: Change supuration
timeFrame: baseline, 6 and 12 months
measure: Change plaque score
timeFrame: baseline, 6 and 12 months
measure: configuration of the bone defect
timeFrame: baseline
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Master Periodoncia. Facultad odontología
state: A Coruña
Study officials:
affiliation: University of Santiago de Compostela
name: Santiago Mareque
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.