Clinical trial NCT06031467: Er,Cr:YSGG Laser Application in Peri-implantitis
Official title: Evaluation of the Effect of Erbium, Chromium:Yttrium-scandium-gallium-garnet (Er,Cr:YSGG) Laser Application on Peri-Implant Crevicular Fluid RANKL and OPG Levels in the Treatment of Peri-implantitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Keywords: Er:Cr:YSGG
biomarkers
laser
osteoprotegerin
peri-implantitis
RANKL
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 49
Sex: ALL
Minimum age (years): 28
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In the present study, investigators, aimed to evaluate the effect of erbium, chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG) laser application combined with mechanical debridement (MD) on clinical parameters and biochemical parameters such as receptor activator of nuclear factor-kappa B ligand (RANKL) and osteoprotegerin (OPG) in patients with peri-implant diseases.

Detailed description: Peri-implantitis is a plaque-associated which involves the tissues around dental implants characterized by inflammation and progressive loss of the supporting alveolar bone. According to a meta-analysis and systematic review, the prevalence of peri-implantitis is about 22%. Biofilm, poor plaque control, and poor dental care after dental implant are implicated in the etiology of disease.

Surface decontamination of the implant is the cornerstone of peri-implantitis treatment. However, there is no sufficient evidence to demonstrate the superiority of a specific decontamination protocol in the literature. Nevertheless, a review recommended the potential use of laser-assisted procedures as an adjunct to mechanical instrumentation and implant detoxification in both non-surgical and regenerative interventions for the treatment of peri-implant diseases. Several studies have examined the role of a variety of laser types in both periodontal and peri-implant treatments and laser application has been shown to play a central role in wound healing and tissue regeneration.

Erbium lasers such as erbium, chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG) use mid-infrared wavelengths which are highly absorbed by water and hydroxyapatite crystals and minerals. In a recent in vitro study, Er,Cr:YSGG laser has been shown to be a safe method in the treatment of peri-implantitis with the dual wavelength protocol. In the literature, there is a limited number of studies using Er,Cr:YSGG laser in the treatment of peri-implantitis in the in vivo setting. Although limited, favorable results have been described in a case report with 18-month follow-up, case reports of including 11 patients, and randomized-controlled clinical studies. Taken together, Er,Cr:YSGG laser seems to be an effective treatment modality in reducing clinical symptoms of peri-implantitis.

The detection of specific biomarkers in the peri-implant crevicular fluid (PICF) is promising to objectively evaluate peri-implant inflammation at baseline and assess treatment efficacy. Biomarkers are host response molecules which reflect a biological state and help to distinguish healthy from diseased tissues or to evaluate disease and its severity.

Recent discoveries regarding the receptor activator of nuclear factor-kappa B ligand (RANKL) and osteoprotegerin (OPG) receptor activator that induce and inhibit osteoclast differentiation have shown that both markers play a role in the molecular network of peri-implant bone resorption. The RANKL is a member of tumor necrosis factor (TNF) superfamily which interacts on osteoclastogenesis. It is secreted by osteoblasts, fibroblasts, and activated T cells and is associated with RANK as a surface-bound molecule which stimulates osteoclast activity. On the other hand, OPG is a soluble decoy receptor for RANKL and expressed by osteoblasts. It also inhibits the osteoclast differentiation and prevents the interaction between RANKL and RANK.

Previous studies have shown high RANKL levels in the crevicular fluid of patients with periodontitis and peri-implantitis compared to healthy dental sites. However, there are controversial results regarding OPG. Several studies have reported significantly higher OPG and RANK levels at peri-implant disease sites compared to healthy implant sites. In addition, significantly higher RANKL protein levels and significantly lower OPG protein levels have been reported in periodontitis tissue. In a study, the PICF level of soluble RANKL was not significantly correlated with clinical parameters and OPG. However, the authors found a positive correlation between the total OPG level and PICF volume, bleeding on probing (BoP) and gingival index (GI).

To the best of investigators' knowledge, there is no study investigating the effect of Er,Cr:YSGG laser as an adjunct to mechanical debridement (MD) on RANKL and OPG in the treatment of peri-implantitis. In the present study, investigators, therefore aimed to evaluate the effect of Er,Cr:YSGG laser application combined with MD on clinical parameters and biochemical parameters such as RANKL and OPG in patients with peri-implant diseases.

Eligibility criteria: Inclusion Criteria:

* bone loss as evidenced by X-ray and inflammatory symptoms in the soft tissue, bleeding and/or suppuration around the implant compatible with peri-implantitis (each patient had a single dental implant or the implant in the deepest pathological pocket not requiring surgical intervention was chosen in case of peri-implantitis in multiple implants);
* radiotherapy or chemotherapy-naïve patients;
* having no bone disease such as osteoporosis or osteopetrosis;
* receiving no bisphosphonate therapy;
* having functional prosthetic loading on the implant for at least six months
* requiring no advanced surgical technique for the treatment of peri-implantitis.

Exclusion Criteria:

* having systemic diseases such as diabetes, autoimmune disorder, renal or hepatic impairment;
* having uncontrolled periodontal disease in natural teeth existing in the mouth;
* smoking habit;
* having parafunctional habits which affect osseointegration of the dental implant;
* receiving antibiotherapy three months before the diagnosis of peri-implantitis;
* having non-osseointegrated dental implant;
* pregnancy and lactation.

Primary outcomes:
measure: Probing depth (mm)
timeFrame: 6 months
measure: Receptor activator of nuclear factor-kappa B ligand (RANKL) level (pg/mL)
timeFrame: 6 months
measure: Osteoprotegerin (OPG) level (ng/mL)
timeFrame: 6 months
Secondary outcomes:
measure: Plaque index score (0-3)
timeFrame: 6 months
measure: Gingival index score (0-3)
timeFrame: 6 months
measure: Bleeding on probing (percentage)
timeFrame: 6 months
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Nazli Zeynep Alpaslan
Study officials:
affiliation: Yuzuncu Yıl University
name: Nazli Zeynep Alpaslan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yuzuncu Yıl University
name: Dicle Altindal, PhD
role: STUDY_CHAIR
affiliation: Private Dental Clinic
name: Damla Akbal, PhD
role: STUDY_CHAIR
affiliation: Yuzuncu Yıl University
name: Ahmet Cemil Talmac, PhD
role: STUDY_CHAIR
affiliation: Saglik Bilimleri Universitesi
name: Serap Keskin Tunc, PhD
role: STUDY_CHAIR
affiliation: Izmir Katip Celebi University
name: Abdullah Seckin Ertugrul, PhD
role: STUDY_CHAIR
References:
citation: Alpaslan Yayli NZ, Talmac AC, Keskin Tunc S, Akbal D, Altindal D, Ertugrul AS. Erbium, chromium-doped: yttrium, scandium, gallium, garnet and diode lasers in the treatment of peri-implantitis: clinical and biochemical outcomes in a randomized-controlled clinical trial. Lasers Med Sci. 2022 Feb;37(1):665-674. doi: 10.1007/s10103-021-03436-5. Epub 2021 Oct 12.