Skip to main content
OpenTrials
Completed

NCT Number: NCT04565886

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology, University of Bern

Bern, 3010, Switzerland

About this study

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. Peri-implantitis is a disease with increasing incidence that, if left untreated, leads to implant loss. The etiological factors of peri-implant infections are similar to those involved in periodontal diseases. Consequently, the goals of peri-implantitis treatment must be the resolution of peri-implant soft tissue inflammation and stabilization of the bony attachment (e.g., the level of osseointegration). This can only be achieved under the condition that the majority of bacterial biofilms and hard deposits are eliminated on the implant surface to create a biologically acceptable surface conducive to wound healing. Decontamination of the implant surface is mandatory to resolve the inflammatory process and to establish healthy peri-implant tissues. 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 mean peri-implant pocket probing depth (PPD) at 12 months. The secondary endpoints are:

  • Change at deepest PPD (mm)
  • Change in probing attachment level (PAL) (mm)
  • Change in the % of implants with BoP / SUP
  • Mean radiographic bone fill (mm) at mesial and distal sites
  • Change in width of keratinized mucosa (KM) (mm)
  • Change in microbial samples composition at 6 and 12 months
  • Changes in patients' related outcomes measures (PROMs) by means of a Visual Analogue Scale (VAS) (range: 0-10)
  • Change in peri-implant crevicular fluid (PICF) composition

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in peri-implant pocket probing depth (PPD)

    Time frame: at 12 months

    the difference between baseline PPD and PPD after 12 months

Secondary outcomes

  1. Change at deepest PPD (mm)

    Time frame: at 12 months

    Difference of baseline and final PPD of the deepest measurment

  2. Change in probing attachment level (PAL) (mm)

    Time frame: at 12 months

    Difference of attachment level from baseline to 12 months

  3. Change in the % of implants with BoP / SUP

    Time frame: at 12 months

    Difference between baseline and final BoP

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

    Time frame: at 12 months

    the distance from the implant shoulder to the bone crest

  5. Change in width of keratinized mucosa (KM) (mm)

    Time frame: at 12 months

    the difference between the baseline and final amount of KM

  6. Change in microbial samples composition

    Time frame: at 6 and 12 months

  7. Changes in patients' related outcomes measures (PROMs) by means of a Visual Analogue Scale (VAS) (range: 0-10)

    Time frame: at 12 months

  8. Change in peri-implant crevicular fluid (PICF) composition

    Time frame: at 12 months

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

Clinical and Radiographic Outcomes Following Non-surgical Mechanical Therapy of Peri-implantitis With or Without Adjunctive Diode Laser Application: A 12-month Double-blinded Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 25, 2020
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.