Non-surgical Mechanical Therapy of Peri-implantitis With or Without Adjunctive Diode Laser Application

NCT04565886 | Completed

• 1 other identifier: 2019-01163
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Peri-implantitis is a pathological condition occurring in tissues around dental implants, characterized by inflammation in the peri-implant connective tissue and progressive loss of supporting bone. The goals of peri-implantitis treatment is the resolution of peri-implant soft tissue inflammation and stabilization of the bony attachment (e.g., the level of osseointegration). For this decontamination of the implant surface is mandatory. In order to increase implant surface decontamination, several adjunctive tools have been proposed and investigated both in pre-clinical and clinical studies such as the use of photodynamic therapy and lasers. So far, no data are available to clearly demonstrate the efficacy of the adjunctive use of a diode laser in the non-surgical treatment of peri-implantitis. Therefore, the aim of the present randomized controlled trial (RCT) is to investigate the adjunctive effect of the application of a diode laser to treat peri-implantitis lesions by means of a non-surgical approach. A total of 30 patients is randomly allocated to two groups. The test group receives 3 x nonsurgical mechanical treatment with diode laser application whereas the control group receives the same treatment with sham laser application. The primary outcome is the peri-implant pocket probing depth at 12 months.

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• Change in peri-implant pocket probing depth (PPD)

  the difference between baseline PPD and PPD after 12 months

  at 12 months

Secondary Outcomes (8)

• Change at deepest PPD (mm)

  at 12 months

• Change in probing attachment level (PAL) (mm)

  at 12 months

• Change in the % of implants with BoP / SUP

  at 12 months

• Mean radiographic bone fill (mm) at mesial and distal sites

  at 12 months

• Change in width of keratinized mucosa (KM) (mm)

  at 12 months

Study Arms (2)

control

SHAM COMPARATOR

Non-surgical mechanical instrumentation 3x. Each time the laser will be held in place but will not be activated.

Device: Sham Diode laser

laser

EXPERIMENTAL

Non-surgical mechanical instrumentation 3x with adjunctive diode laser application according to the protocol of the Department of Periodontology, University of Bern

Device: Diode laser application

Interventions

Diode laser application DEVICE

After mechanical debridement, the pockets around the implant will be rinsed with sterile saline solution. Adjunctive diode laser (settings: 810 nm, 2.5 W, 50 Hz, 10 ms) will be applied 3x for 30 s (i.e., 90 s per appointment) using a 400-lm thick fiber (WhiteStar, Orcos Medical AG, Küsnacht, Switzerland) in the test group. In the control group, non-activated (= placebo) adjunctive diode laser will be applied. The entire treatment procedure, including mechanical debridement, will be performed at Day 0 (= baseline), 7 and 14. The laser decontamination procedure will occur by systematically moving the laser tip along the subgingival implant surface in a vertical and horizontal scanning way. The laser tip will be checked after 4-5 s for coagulation to prevent hotspots in the soft tissues.

laser

Sham Diode laser DEVICE

After mechanical debridement, the pockets around the implant will be rinsed with sterile saline solution. Non-activated (= placebo) adjunctive diode laser will be applied. The entire treatment procedure, including mechanical debridement, will be performed at Day 0 (= baseline), 7 and 14. The laser decontamination procedure will occur by systematically moving the laser tip along the subgingival implant surface in a vertical and horizontal scanning way.

control

Eligibility Criteria

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

You may qualify if:

• systemically healthy patients enrolled in regular supportive periodontal therapy (SPT)
• Tissue level (TL) implants with an SLA surface supporting single-unit crowns (SUCs) or fixed dental prostheses (FDPs)
• Pocket Probing Depth (PPD) \> 5 mm
• Presence of BoP and /or SU
• Radiographic evidence of crestal bone loss ≤ 2mm based on periapical radiographs after delivery of the final restoration
• Cleansable cemented or screw-retained restoration
• Presence of at least 2 mm of keratinized and attached mucosa (KM)
• Signed informed consent

You may not qualify if:

• Systemic diseases that could interfere with the treatment outcome (e.g. uncontrolled diabetes mellitus, chemotherapy, etc.)
• Previous peri-implantitis treatment
• Full-Mouth Plaque Score (FMPS) \> 25%
• Full-Mouth Bleeding Score (FMBS) \> 25%
• Cigarette smoking \> 10 cig./day
• Removable implant-supported restorations
• Implant mobility

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Department of Periodontology, University of Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised placebo controlled monocentric trial

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 25, 2020
• Study Start: December 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: July 1, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

CH (1)