Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 4
- Primary Endpoint
- Mean change from baseline in Pocket probing depth (PPD) at 6 months after treatment.
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Masking for the assessors of microbial, immunological and radiographic analyses.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Scaling and root planning + Laser treatment
Intervention: Laser treatment (Device)
Mucosal flap surgery
Intervention: Mucosal flap surgery (Procedure)
Outcomes
Primary Outcomes
Mean change from baseline in Pocket probing depth (PPD) at 6 months after treatment.
Time Frame: 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 Outcomes
- Bacterial composition of the subgingival microflora(At baseline and 6 months post treatment)
- Mean change from baseline in Plaque index (PI) at 6 months after treatment.(At baseline and 6 months post treatment)
- Mean change from baseline in the inflammatory response in the inflammatory exudates at 6 months after treatment.(At baseline and 6 months post treatment)
- Mean change from baseline in Bleeding on probing (BOP) at 6 months after treatment.(At baseline and 6 months post treatment)
- Mean change from baseline in Recession of the marginal mucosa at 6 months after treatment.(At baseline and 6 months post treatment)
- Mean change from baseline in Patient reported outcome using the VAS score directly post treatment.(At baseline and immediately post 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.)
- Mean change from baseline in Presence of suppuration at 6 months after treatment.(At baseline and 6 months post treatment)
- Mean change from baseline in Marginal bone level on radiographs at 6 months after treatment.(At baseline and 6 months post treatment)
Investigators
Annsofi Johannsen
Registered Dental Hygienist (RDH); Associate professor
Karolinska Institutet