Surgical Protocol for Peri-implantitis Treatment

NCT03801187 | Unknown DMC

• 1 other identifier: peri-implant surgical-1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Peri-implant diseases are common post-restorative complications in implant rehabilitations and they occur with an incidence of 12-43%. Based on the available data in literature, the surgical therapy for peri-implantitis is effective in disease resolution. Surgical access to peri-implant lesions facilitates the removal of all granulation tissue from the defect area as well as debridement and decontamination of the exposed implant surface defect area. Different techniques have been used for implant surface decontamination during peri-implant surgery, including mechanical, chemical and laser treatments.

Conditions

Peri-implantitis

Keywords

peri-implantitis; surgical treatment; Er:Yag laser; Air-flow; chlorhexidine

Outcome Measures

Primary Outcomes (1)

• Bleeding on probing changes

  changes of bleeding on probing, evaluated as present if bleeding will be evident within 30 s after probing, or absent, if no bleeding will be noticed within 30 s after probing,

  baseline, 3, 6 and 12 months after treatment

Secondary Outcomes (4)

• clinical attachment level changes

  baseline, 3, 6 and 12 months after treatment

• probing pocket depth changes

  baseline, 3, 6 and 12 months after treatment

• mucosal recession changes

  baseline, 3, 6 and 12 months after treatment

• bone level changes

  baseline and 12 months after treatment

Study Arms (3)

Chlorhexidine

SHAM COMPARATOR

Access flap will be raised to gain access to the implant surface. Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in Chlorhexidine.

Procedure: chlorhexidine

Er:YAG laser

EXPERIMENTAL

Er: Yag laser treatment will be provided on the implant surface.

Procedure: chlorhexidine; Procedure: Er:YAG laser

Air Powder

ACTIVE COMPARATOR

An Air-Powder treatment will be provided on the implant surface

Procedure: chlorhexidine; Procedure: Air-Powder

Interventions

chlorhexidine PROCEDURE

Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in chlorhexidine.

Air Powder; Chlorhexidine; Er:YAG laser

Er:YAG laser PROCEDURE

Er.YAg laser treatment will be provided on the implant surface.

Er:YAG laser

Air-Powder PROCEDURE

An air powder device will be treatment will be provided on the implant surface.

Air Powder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of at least one screw-type titanium implant exhibiting bleeding and/or suppuration on probing combined with:
• PPD ≥ 5 mm and bone loss ≥ 2 mm (compared to crestal bone levels at the time of placement of the reconstruction)
• PPD ≥6 and bone loss ≥3 (not compared to crestal bone levels at the time of placement of the reconstruction)
• single tooth and bridgework restorations without overhangs
• no evidence of occlusal overload (i.e. occlusal contacts revealed appropriate adjustment),
• treated chronic periodontitis and proper periodontal maintenance care
• FMPS \< 20%
• non-smoker or light smoking status in smokers (\<10 cigarettes per day)
• implant function time ≥ 1 year.

You may not qualify if:

• Patients with uncontrolled diabetes
• patients with osteoporosis or under bisphosphonate medication,
• pregnant or lactating women
• patients with a history of radiotherapy to the head and neck region
• hollow implants
• implant mobility
• implants at which no position could be identified where proper probing measurements could be performed;
• previous surgical treatment of the peri-implantitis lesions

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (1)

Università Vita-Salute San Raffaele

Milan, 20100, Italy

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Chlorhexidine; Lasers, Solid-State

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Massimo De Sanctis, Prof.

  Università Vita-Salute San Raffaele

  STUDY CHAIR

Central Study Contacts

Marco Clementini

CONTACT

0226432806; mclementini@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: July 2, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2021
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

IT (1)