Peri-Implantitis Clinical Trial
Official title:
Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery
Verified date | July 2019 |
Source | Sirona Dental Systems GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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). |
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 |
Lead Sponsor | Collaborator |
---|---|
Sirona Dental Systems GmbH |
Sweden,
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 |
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