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

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04323540
• Other study ID #: 18117
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2020
• Source: George Eastman Dental Hospital, Italy
• Contact: Lucrezia Paternò Holtzman, DMD
• Phone: +39.06.3241406
• Email: lucreziaph[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
George Eastman Dental Hospital, Italy	University of Belgrade

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Probing depth	linear distance (mm) from the gingival margin to the bottom of the pocket	6, 12, 18, 24 months
Secondary	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
Secondary	Mucosal recession	linear distance (mm) from the implant platform to the gingival margin	6, 12, 18, 24 months
Secondary	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
Secondary	profuse bleeding	abundant bleeding evoked upon probing immediately after	6, 12, 18, 24 months
Secondary	BOP	bleeding upon probing: bleeding evoked upon probing after 1 second	6, 12, 18, 24 months
Secondary	suppuration	Binary: yes or no, detected upon probing or digital palpation	6, 12, 18, 24 months
Secondary	Gingival thickness	Measured in a horizontal direction at 1 mm from the gingival margin	6, 12, 18, 24 months
Secondary	Patient-reported outcome measures	pain-bleeding-aesthetic self-evaluation-swelling-discomfort	6, 12, 18, 24 months
Secondary	Radiographic bone levels	radiographic bone level changes between the 2 week and 12 and 24 month follow-ups	2 weeks, 12 months, 24 months