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

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04249024
• Other study ID #: Peri-implantitis 970 nm laser
• Status: Completed
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: June 21, 2022

Study information

• Verified date: November 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 21, 2022
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

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.

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.

Locations

Country	Name	City	State
Sweden	Danakliniken Specialist Dentistry	Danderyd	Stockholms Län
Sweden	Specialist Dentistry Clinic, Karolinska Institutet, Dept. of Dental Medicine	Huddinge	Stockholms Län

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in pocket probing depth (PPD)	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.	0-6 months
Secondary	Mean change in plaque index (PI)	Plaque index (PI) will be measured at 4 sites per implant and assessed as per cent of the total amount of measured implant surfaces.	0-6 months
Secondary	Mean change in bleeding on probing (BOP)	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.	0-6 months
Secondary	Mean change in presence of suppuration	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.	0-6 months
Secondary	Mean change in marginal bone level on radiographs	Measured on radiographs for a fixed point on the dental implant to the marginal bone level.	0-6 months
Secondary	Mean change in inflammatory response in peri-implant crevicular fluid (PICF)	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-1ß, MMP 8, TIMP-1, CSF-1, elastase activity, and RANK-L/OPG ratio.	0-6 months
Secondary	Mean change in inflammatory response in saliva	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-1ß, MMP 8, TIMP-1, CSF-1, elastase activity, and RANK-L/OPG ratio.	0-6 months
Secondary	Composition of the subgingival microflora	The bacterial composition in the subgingival microflora will be analyzed by quantitative real-time Polymerase Chain Reaction (qPCR).	0-6 months
Secondary	Mean change in patient reported outcome using the visual analogue scale (VAS) score	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.	Baseline, directly after treatment, 10 days after and 6 months after treatment.