Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03624257
Other study ID # Peri-implantitis 445 nm laser
Secondary ID CIV-1 8-06-02430
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2018
Est. completion date June 2020

Study information

Verified date July 2019
Source Sirona Dental Systems GmbH
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 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.


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:

- To evaluate other clinical and radiological variables connected to peri-implantitis and the inflammation surrounding the dental implant.

- To evaluate the patient experience of a novel blue laser for treatment of peri-implantitis.

- To evaluate the inflammatory and microbial response after laser treatment


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2020
Est. primary completion date June 2020
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 by a combination of scaling and root planning (SRP) and 445 nm diode laser. The peri-implant pocket will be radiated with the 445 nm laser, removing bacteria, diseased epithelium and granulation tissue. The Power setting on the laser will be 0.7 W continuous wave and will be used at maximum 20 s Before cooling water is applied. 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, in combination with scaling and root planning (SRP), and return after 7-10 days for suture removal. The surgery is a well-established treatment of peri-implantitis.

Locations

Country Name City State
Sweden Danakliniken Specialist Dentistry, Mörby Centrum floor 5 Danderyd
Sweden Specialist Dentistry Clinic, Karolinska Institutet, Dept. of Dental Medicine, Karolinska Institutet Huddinge

Sponsors (1)

Lead Sponsor Collaborator
Sirona Dental Systems GmbH

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change from baseline in Pocket probing depth (PPD) at 6 months after 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. At baseline and 6 months post treatment
Secondary Mean change from baseline in Plaque index (PI) at 6 months after treatment. Plaque index (PI) will be measured at 4 sites per implant and assessed as per cent of the total amount of measured implant surfaces. At baseline and 6 months post treatment
Secondary Mean change from baseline in Bleeding on probing (BOP) at 6 months after treatment. 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. At baseline and 6 months post treatment
Secondary Mean change from baseline in Recession of the marginal mucosa at 6 months after treatment. Recession of the marginal mucosa will be measured from a per implant decided fixed point like the shoulder of the implant or the edge of the prosthetic to the marginal mucosa. Registered on 4 surfaces surrounding the implant. At baseline and 6 months post treatment
Secondary Mean change from baseline in Presence of suppuration at 6 months after treatment. 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. At baseline and 6 months post treatment
Secondary Mean change from baseline in Marginal bone level on radiographs at 6 months after treatment. At baseline and 6 months post treatment
Secondary Mean change from baseline in Patient reported outcome using the VAS score directly post treatment. Visual analogue scale (VAS) is used to record the patients pain, discomfort and satisfaction with the treatment. At baseline and immediately post treatment.
Secondary Mean change from baseline in Patient reported outcome using the VAS score at 10 days post treatment. Visual analogue scale (VAS) is used to record the patients pain, discomfort and satisfaction with the treatment. At baseline and 10 days post treatment.
Secondary Mean change from baseline in the inflammatory response in the inflammatory exudates at 6 months after treatment. Analysis of inflammatory meditators in gingival crevicular fluid (GCF) and saliva will be performed by commercially available ELISAs or multiplex assays. At baseline and 6 months post treatment
Secondary Bacterial composition of the subgingival microflora The bacterial composition in the subgingival microflora will be analyzed by quantitative real-time Polymerase Chain Reaction (qPCR). At baseline and 6 months post treatment
See also
  Status Clinical Trial Phase
Completed NCT05332327 - Comparison of the Accuracy of Different Periodontal Probes for Peri-implant Pocket Registration
Enrolling by invitation NCT06063876 - Experimental Peri-implant Mucositis on Implant Sites That Were Previously Treated With or Without Implantoplasty N/A
Completed NCT04249024 - Peri-implantitis, Comparing Treatments 970 nm Laser and Mucosal Flap Surgery N/A
Completed NCT02375750 - Treatment of Peri-implantitis Lesions by Using Biomaterial N/A
Completed NCT03157193 - Effect of Hyaluronic Acid on Perimplantitis Phase 4
Completed NCT03018795 - Ozone Therapy as an Adjunct to the Surgical Treatment of Peri-implantitis N/A
Enrolling by invitation NCT02575274 - Peri-Implantitis Surgical Treatment an RCT Study Phase 2/Phase 3
Completed NCT04833569 - ICG-PDT, Periimplantitis, Diabetes Mellitus Phase 1
Not yet recruiting NCT04337645 - Resective Surgical Treatment of Peri-implantitis. N/A
Enrolling by invitation NCT06033859 - Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression
Active, not recruiting NCT06390124 - Reconstructive Therapy of Peri-implantitis With PDGF-BB (Gem-21) Phase 4
Enrolling by invitation NCT05675241 - Characterizing the Inflammation Around Dental Implants
Recruiting NCT04983758 - 20-year Implant Survival in Periodontally Healthy and Compromised Patients
Not yet recruiting NCT04323540 - Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation N/A
Completed NCT04769609 - Reconstructive Surgical Therapy of Peri-implantitis
Completed NCT04874467 - Influence of Keratinized Mucosa on Dental Implants With Mucositis N/A
Completed NCT05724706 - An Evaluation of Salivary Oxidant and Antioxidant Levels in Peri-implant Health and Disease
Completed NCT04559841 - Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin N/A
Recruiting NCT05906810 - Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis N/A
Completed NCT05595746 - Radiological Bone Loss on Different Levels of Dental Implants N/A