Peri-implantitis, Comparing Treatments 970 nm Laser and Mucosal Flap Surgery

Not Applicable

Completed

• Conditions: Peri-Implantitis
• Interventions: Device: Laser treatment; Procedure: Mucosal flap surgery; Behavioral: Oral hygiene instructions

• Registration Number: NCT04249024
• Lead Sponsor: Karolinska Institutet

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 970 nm laser 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 wellbeing 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 970 nm laser 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 treatment of peri-implantitis.

* To evaluate the inflammatory and microbial response after laser treatment

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-09-25
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-30
• Primary Completion: 2022-06-21
• Study Completion: 2022-06-21
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser treatment	Laser treatment	Laser treatment with diode laser 970nm and settings 1.2W in intervals of max 20s, until satisfactory removal of diseased epithelium and granulation tissue.
Mucosal flap surgery	Oral hygiene instructions	Conventional mucosal flap surgery of affected dental implant.
Laser treatment	Oral hygiene instructions	Laser treatment with diode laser 970nm and settings 1.2W in intervals of max 20s, until satisfactory removal of diseased epithelium and granulation tissue.
Mucosal flap surgery	Mucosal flap surgery	Conventional mucosal flap surgery of affected dental implant.

Primary Outcome Measures

Name	Time	Method
Mean change in pocket probing depth (PPD)	0-6 months	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
Mean change in marginal bone level on radiographs	0-6 months	Measured on radiographs for a fixed point on the dental implant to the marginal bone level.
Mean change in plaque index (PI)	0-6 months	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 in bleeding on probing (BOP)	0-6 months	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.
Composition of the subgingival microflora	0-6 months	The bacterial composition in the subgingival microflora will be analyzed by quantitative real-time Polymerase Chain Reaction (qPCR).
Mean change in patient reported outcome using the visual analogue scale (VAS) score	Baseline, directly after treatment, 10 days after and 6 months after treatment.	Visual analogue scale (VAS) is used to record the patients pain, discomfort and satisfaction with the treatment. The patients mark their response on a 100 mm line, with low values being no feeling of pain, discomfort or satisfaction, and high values meaning maximum pain, discomfort or satisfaction.
Mean change in inflammatory response in saliva	0-6 months	Analysis of inflammatory meditators in stimulated saliva will be performed by commercially available ELISAs or multiplex assays at base line and 6 months. The analytes of interest to be tested are mainly inflammatory cytokines, chemokines, growth factors, proteases, and molecules related to bone remodeling such as for IL-1β, MMP 8, TIMP-1, CSF-1, elastase activity, and RANK-L/OPG ratio.
Mean change in presence of suppuration	0-6 months	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 in inflammatory response in peri-implant crevicular fluid (PICF)	0-6 months	Analysis of inflammatory meditators in PICF will be performed by commercially available ELISAs or multiplex assays at base line and 6 months. The analytes of interest to be tested are mainly inflammatory cytokines, chemokines, growth factors, proteases, and molecules related to bone remodeling such as for IL-1β, MMP 8, TIMP-1, CSF-1, elastase activity, and RANK-L/OPG ratio.

Trial Locations

Locations (2)

Danakliniken Specialist Dentistry; 🇸🇪 Danderyd, Stockholms Län, Sweden

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