Regenerative Surgical Treatment of Peri-implant Defects

Regenerative Surgical Treatment of Peri-implant Defects. Submerged Versus Not Submerged

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.

Study Overview

• Status: Recruiting
• Conditions: Implant Site Pocket Infection
• Intervention / Treatment: Procedure: regenerative treatment periimplantitis

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.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Santiago Mareque; Phone Number: 616 975 256‬; Email: smareque@gmail.com
• Study Contact Backup: Name: Juan Blanco; Phone Number: 616 975 256‬; Email: smareque@gmail.com

Study Locations

• Spain
  • A Coruña
    • Santiago De Compostela, A Coruña, Spain, 15782
      • Recruiting
      • Master Periodoncia. Facultad odontología
      • Contact: Santiago Mareque; Email: smareque@gmail.com
      • Contact: Carlota Blanco; Email: carlota.blanco@rai.usc.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test group; submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.	Procedure: 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.
EXPERIMENTAL: Control group; non submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes marginal bone level	measured on periapical X-rays, from the shoulder of the implant to the bottom of the bone defect next to the implant at the mesial and distal surfaces. Mean marginal bone levels between mesial and distal measurements will be calculated.	baseline, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes Probing pocket depth	distance from the margin gingival to the bottom of the peri-implant pouch. All clinical variables will be recorded with a Hu-friedy CP15 UNC millimeter probe in six points on each implant.	baseline, 6 and 12 months
Changes Clinical attachment level	Distance from the implant shoulder or prosthetic abutment to the bottom of the peri-implant pocket.	baseline, 6 and 12 months
Change Reccesion	distance from the margin of the peri-implant mucosa to the implant / abutment interface.	baseline, 6 and 12 months
Change Keratinized mucosa	distance from the gingival margin up to the mucogingival line.	baseline, 6 and 12 months
Change blending on probing	Registry of presence of bleeding by binary scale (1 bleed present / 0 bleed absent)	baseline, 6 and 12 months
Change supuration	Pus presence register by scale binary (1 present / 0 absent)	baseline, 6 and 12 months
Change plaque score	Registration of presence of plaque by binary scale on each surface (1 present / 0 absent), calculating the percentage of total surfaces in which plaque is detected by using a periodontal probe	baseline, 6 and 12 months
configuration of the bone defect	Based on the classification of Schwarz et al. (2007)	baseline

Collaborators and Investigators

• Sponsor: University of Santiago de Compostela
• Collaborators: Osteology Foundation
• Investigators: Study Director: Santiago Mareque, University of Santiago de Compostela

Publications and helpful links

General Publications

• 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. Erratum In: Clin Oral Implants Res. 2007 Jun;18(3):397.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (ACTUAL): June 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: REGT_CT_19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No