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

Sponsor

Karolinska Institutet (Other)

Overall Status

Recruiting

CT.gov ID

NCT04249024

Collaborator

(none)

Enrollment

Locations

Arms

31.2

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peri-Implantitis	Device: Laser treatment Procedure: Mucosal flap surgery Behavioral: Oral hygiene instructions	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Masking for the assessors of microbial, immunological and radiographic analyses.

Primary Purpose:

Treatment

Official Title:

Comparing Treatment of Peri-implantitis With Either 970 nm Laser or Conventional Mucosal Flap Surgery - a Prospective Randomized Controlled Trial

Actual Study Start Date :

Sep 25, 2019

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laser treatment	Device: Laser treatment The participants in the laser group are treated with a 970 nm diode laser and if calculus is present scaling and root planning (SRP). The peri-implant pocket will be radiated with the 970 nm laser, removing bacteria, diseased epithelium and granulation tissue. The laser will be used at a maximum of 20s intervals before water irrigation. Laser settings continuous wave mode and power between 1.0-1.3W. Total treatment time will vary with the depth of the pocket and size of the surrounding bone crater. Behavioral: Oral hygiene instructions Oral hygiene instructions of how to clean around dental implants as per individual needs in terms of access to clean and fine motor skills.
Active Comparator: Mucosal flap surgery	Procedure: Mucosal flap surgery The participants will receive a conventional peri-implant mucosal flap surgery of affected implants, and return after 7-10 days for suture removal. The surgery is a well-established treatment of peri-implantitis. Behavioral: Oral hygiene instructions Oral hygiene instructions of how to clean around dental implants as per individual needs in terms of access to clean and fine motor skills.

Arm

Intervention/Treatment

Experimental: Laser treatment

Device: Laser treatment

The participants in the laser group are treated with a 970 nm diode laser and if calculus is present scaling and root planning (SRP). The peri-implant pocket will be radiated with the 970 nm laser, removing bacteria, diseased epithelium and granulation tissue. The laser will be used at a maximum of 20s intervals before water irrigation. Laser settings continuous wave mode and power between 1.0-1.3W. Total treatment time will vary with the depth of the pocket and size of the surrounding bone crater.

Behavioral: Oral hygiene instructions

Oral hygiene instructions of how to clean around dental implants as per individual needs in terms of access to clean and fine motor skills.

Active Comparator: Mucosal flap surgery

Procedure: Mucosal flap surgery

The participants will receive a conventional peri-implant mucosal flap surgery of affected implants, and return after 7-10 days for suture removal. The surgery is a well-established treatment of peri-implantitis.

Behavioral: Oral hygiene instructions

Oral hygiene instructions of how to clean around dental implants as per individual needs in terms of access to clean and fine motor skills.

Outcome Measures

Primary Outcome Measures

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

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.
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 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 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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Danakliniken Specialist Dentistry	Danderyd	Stockholms Län	Sweden	18231
2	Specialist Dentistry Clinic, Karolinska Institutet, Dept. of Dental Medicine	Huddinge	Stockholms Län	Sweden	14152