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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04249024
Other study ID # Peri-implantitis 970 nm laser
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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.
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