Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery

Not Applicable

Withdrawn

• Conditions: Peri-Implantitis
• Interventions: Procedure: Mucosal flap surgery; Device: Laser treatment

• Registration Number: NCT03624257
• Lead Sponsor: Sirona Dental Systems GmbH

Brief Summary

A clinical trial comparing laser treatment and conventional mucosal flap surgery for treatment of peri-implantitis. The main aim of the study is to evaluate if treatment of peri-implantitis with a novel blue laser (445 nm) combined with scaling and root planning (SRP) is clinically comparable to conventional mucosal flap surgery in terms of pocket probing depth reduction.

Detailed Description

The present project aims to evaluate a novel method in treating peri-implantitis, with focus on decreasing the patient's suffering as well as disease progression. Peri-implantitis has a direct influence on both physical and psychological well-being and have been related to difficulty in chewing due to loss of implants, bad esthetic appearance as well as high costs. Therefore, it is of importance for the individual as well as for the society to thoroughly investigate any new treatment approaches.

The study is a prospective randomized clinical trial comparing laser treatment (test group) and conventional mucosal flap surgery (active control group). Assessment of clinical variables at baseline and after 6 months. Patient reported outcomes at baseline, directly after treatment and after 10 days.

Primary Objective:

To evaluate if treatment of peri-implantitis with a novel blue laser (445 nm) combined with scaling and root planning (SRP) is clinically comparable to conventional mucosal flap surgery in terms of pocket probing depth reduction.

Secondary Objectives:

* To evaluate other clinical and radiological variables connected to peri-implantitis and the inflammation surrounding the dental implant.

* To evaluate the patient experience of a novel blue laser for treatment of peri-implantitis.

* To evaluate the inflammatory and microbial response after laser treatment

Study Timeline

• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-10
• Study Start: 2018-09
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Signs of peri-implantitis around one or more dental implants. All criteria below need to be fulfilled for inclusion.

  • Presence of pocket probing depth (PPD) > 5 mm
  • Bleeding on probing/suppuration (BOP/Pus)
  • At least 2 mm loss of bone, visible on radiographs, after initial osseointegration.

• ≥ 18 years old.

• Patient able to understand Swedish.

Exclusion Criteria

• Antibiotic treatment 6 months prior to baseline.
• Peri-implant treatment 6 months prior to baseline.
• Myocardial infarction 6 months prior to baseline.
• Previous radiation treatment in the affected jaw area.
• Previous i.v. bisphosphonate treatment.
• Moderate or severe impairment of cognitive function (e.g. dementia).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mucosal flap surgery	Mucosal flap surgery	-
Scaling and root planning + Laser treatment	Laser treatment	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in Pocket probing depth (PPD) at 6 months after treatment.	At baseline and 6 months post treatment	Pocket probing depth (PPD) will be measured by a 1 mm graded pocket probe from the bottom of the peri-implant pocket to the marginal mucosa and will be registered on 4 surfaces surrounding the implant.

Secondary Outcome Measures

Name	Time	Method
Bacterial composition of the subgingival microflora	At baseline and 6 months post treatment	The bacterial composition in the subgingival microflora will be analyzed by quantitative real-time Polymerase Chain Reaction (qPCR).
Mean change from baseline in Plaque index (PI) at 6 months after treatment.	At baseline and 6 months post treatment	Plaque index (PI) will be measured at 4 sites per implant and assessed as per cent of the total amount of measured implant surfaces.
Mean change from baseline in the inflammatory response in the inflammatory exudates at 6 months after treatment.	At baseline and 6 months post treatment	Analysis of inflammatory meditators in gingival crevicular fluid (GCF) and saliva will be performed by commercially available ELISAs or multiplex assays.
Mean change from baseline in Bleeding on probing (BOP) at 6 months after treatment.	At baseline and 6 months post treatment	BOP will be registered on 4 surfaces surrounding the implant after probing the peri-implant pocket with a pocket probe, up to 20 s after the provocation with the probe.
Mean change from baseline in Recession of the marginal mucosa at 6 months after treatment.	At baseline and 6 months post treatment	Recession of the marginal mucosa will be measured from a per implant decided fixed point like the shoulder of the implant or the edge of the prosthetic to the marginal mucosa. Registered on 4 surfaces surrounding the implant.
Mean change from baseline in Patient reported outcome using the VAS score directly post treatment.	At baseline and immediately post treatment.	Visual analogue scale (VAS) is used to record the patients pain, discomfort and satisfaction with the treatment.
Mean change from baseline in Patient reported outcome using the VAS score at 10 days post treatment.	At baseline and 10 days post treatment.	Visual analogue scale (VAS) is used to record the patients pain, discomfort and satisfaction with the treatment.
Mean change from baseline in Presence of suppuration at 6 months after treatment.	At baseline and 6 months post treatment	Presence of suppuration will be registered on 4 surfaces surrounding the implant after probing the peri-implant pocket with a pocket probe, up to 20 s after the provocation with the probe.
Mean change from baseline in Marginal bone level on radiographs at 6 months after treatment.	At baseline and 6 months post treatment

Trial Locations

Locations (2)

Danakliniken Specialist Dentistry, Mörby Centrum floor 5; 🇸🇪 Danderyd, Sweden

Specialist Dentistry Clinic, Karolinska Institutet, Dept. of Dental Medicine, Karolinska Institutet; 🇸🇪 Huddinge, Sweden