Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation

Surgical Reconstructive Treatment of Peri-Implantitis With or Without Simultaneous Soft Tissue Augmentation: a Multi-center Randomized Controlled Trial

The study will aim to compare two modalities in the reconstructive treatment of peri-implantitis defects. More specifically, the control group will be a reconstructive approach (xenograft bone graft granules and collagen membrane, BioOss and BioGide, Geistlich, Wolhusen). The test group will be the same with the exception of an autologous sub-epithelial connective tissue palatal graft, sutured beneath the flap, which will be used in addition to grafting materials.

Outcomes will include CAL, PD, MR, defect resolution, PI, BoP, SUPP, patient-reported outcome measures including an aesthetic self-evaluation.

Study Overview

• Status: Not yet recruiting
• Conditions: Peri-Implantitis
• Intervention / Treatment: Procedure: Peri-implantitis reconstructive surgery

Detailed Description

The study will aim to compare two modalities in the reconstructive treatment of peri-implantitis defects.

More specifically, the control group will be a "pure" reconstructive approach (xenograft bone graft granules and reservable collagen membrane, BioOss and BioGide, Geistlich, Wolhusen). This is in accordance with gold standard practices of reconstructive therapy of peri-implant defects.

The test group will be treated with the same approach and materials, with the exception of an autologous sub-epithelial connective tissue palatal graft, sutured beneath the flap, which will be used in addition to the grafting materials. The graft will be harvested from the homolateral palate (molar region).

Outcomes will include CAL, clinical attachment level (primary outcome), PD or probing depth, MR or mucosal recession, defect resolution (composite outcome made up of simultaneous absence of PD>5 mm, BOP/SUP and bone level changes >0.5 mm, PI, BoP or bleeding upon probing, suppuration SUP on probing, SUP on palpation, patient-reported outcome measures including an aesthetic self-evaluation.

The measures will be recorded at baseline, 6-, 12-, 18- and 24 months. Radiographic bone levels will be compared with 2 week image at 12 and 24 months

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucrezia Paternò Holtzman, DMD; Phone Number: +39.06.3241406; Email: lucreziaph@gmail.com
• Study Contact Backup: Name: Iva Milinkovic, DMD, PhD; Email: iva.milinkovic@gmail.com

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:

• · Be able and willing to provide consent and sign the informed consent form.

  • Be able and willing to comply with study procedures and follow-up appointments required by the study protocol.
  • Age>18 years
  • Presence of at least one implant affected with peri-implantitis, defined as the following con-dition: at least one site presenting peri-implant probing depth (PPD) >6 mm and simultane-ous presence of profuse BoP/SUP and a radiographically documented change in bone level greater than initial bone remodeling. In the likely event that a baseline radiographic image is absent, the bone level will be compared to where it would likely have been at the time of implant insertion and a difference of >3 mm from that level will be considered.
  • Implants in function (i.e. loaded) for at least 1 year.
  • Screw- and cement-retained suprastructures for both fixed and removable prostheses.

Exclusion Criteria:

• Compromised systemic health which contraindicates the study procedures.
• Pregnant or nursing women.
• Cigarette smoking>5 per day
• Systemic conditions compromising healing (i.e. diabetes mellitus). Patients with diabe-tes mellitus types I or II will be asked to provide information regarding their most re-cent HbA1c values. Only patients with HbA1c<7% will be enrolled.
• Patients taking medications known to interfere with gingival or bone metabolism.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Xenograft+collagen membrane; Reconstructive approach (Xenograft+collegen membrane)	Procedure: Peri-implantitis reconstructive surgery; For both arms (excluding the already included information): defect debridement, removal of debris using titanium curettes, titanium brushes on the implant surface, irrigation with saline, application of sterile cotton pellets with saline solution. Grafting with (experimental) xenograft and soft tissue, or xenograft alone (control). Suture. Specific to control group (active comparator): the peri-implant defect will be filled with xenograft, and a collagen membrane will be fitted and trimmed to the defect area. Specific to test/experimental group: same as above (for control). In addition a soft tissue graft will be harvested from the palate and sutured to the buccal flap. The entire flap will then be sutured to the lingual flap.
Experimental: Xenograft+collagen membrane+autologous soft tissue graft; Reconstructive approach (Xenograft+collegen membrane) plus soft tissue graft (autologous, harvested as FGG)	Procedure: Peri-implantitis reconstructive surgery; For both arms (excluding the already included information): defect debridement, removal of debris using titanium curettes, titanium brushes on the implant surface, irrigation with saline, application of sterile cotton pellets with saline solution. Grafting with (experimental) xenograft and soft tissue, or xenograft alone (control). Suture. Specific to control group (active comparator): the peri-implant defect will be filled with xenograft, and a collagen membrane will be fitted and trimmed to the defect area. Specific to test/experimental group: same as above (for control). In addition a soft tissue graft will be harvested from the palate and sutured to the buccal flap. The entire flap will then be sutured to the lingual flap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level	linear distance (mm) from the implant platform to the bottom of the pocket	change from baseline to: 6, 12, 18, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing depth	linear distance (mm) from the gingival margin to the bottom of the pocket	6, 12, 18, 24 months
Disease resolution	No PD greater than or equal to 5 mm and simultaneous absence of BOP/SUP and no more than 0.5 mm change between 2 weeks and 12 and 24 months on radiograph	6, 12, 18, 24 months
Mucosal recession	linear distance (mm) from the implant platform to the gingival margin	6, 12, 18, 24 months
plaque index (minimum value 0, maximum 1)	binary outcome: yes/ no detected running the probe into the peri-implant sulcus	6, 12, 18, 24 months
profuse bleeding	abundant bleeding evoked upon probing immediately after	6, 12, 18, 24 months
BOP	bleeding upon probing: bleeding evoked upon probing after 1 second	6, 12, 18, 24 months
suppuration	Binary: yes or no, detected upon probing or digital palpation	6, 12, 18, 24 months
Gingival thickness	Measured in a horizontal direction at 1 mm from the gingival margin	6, 12, 18, 24 months
Patient-reported outcome measures	pain-bleeding-aesthetic self-evaluation-swelling-discomfort	6, 12, 18, 24 months
Radiographic bone levels	radiographic bone level changes between the 2 week and 12 and 24 month follow-ups	2 weeks, 12 months, 24 months

Collaborators and Investigators

• Sponsor: George Eastman Dental Hospital, Italy
• Collaborators: University of Belgrade
• Investigators: Principal Investigator: Luca Cordaro, MD, PhD, G. Eastman Dental Hospital Rome, Italy

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: 18117 (Other Identifier: City of Hope Medical Center)

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