Er,Cr:YSGG Laser Application in Peri-implantitis

NCT06031467 | Completed

• 1 other identifier: 29.01.2020/11
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-Implantitis

Keywords

Er:Cr:YSGG; biomarkers; laser; osteoprotegerin; peri-implantitis; RANKL

Outcome Measures

Primary Outcomes (3)

• Probing depth (mm)

  Probing depth (PD) (distance from peri-implant margin to peri-implant pocket base) was measured with a plastic probe in 4 regions (mesial, buccal, distal, lingual / palatial) of each implant and recorded as mm.

  6 months

• Receptor activator of nuclear factor-kappa B ligand (RANKL) level (pg/mL)

  All PICF samples were collected before clinical measurements. During sample collection, the implants were isolated using cotton rolls and dried gently with an air freshener, and paper strips were advanced into the pocket until resistance was felt. The paper strips were kept in the peri-implant pocket for 30 sec. Paper strips were placed in 500-µL sterilized Eppendorf® tubes to which phosphate-buffered saline (PBS) was added. All samples were kept at -40° until analysis. The enzyme-linked immunosorbent assay (ELISA) was used to measure RANKL levels in the PICF samples in accordance with the manufacturer's instructions.

  6 months

• Osteoprotegerin (OPG) level (ng/mL)

  All PICF samples were collected before clinical measurements. During sample collection, the implants were isolated using cotton rolls and dried gently with an air freshener, and paper strips were advanced into the pocket until resistance was felt. The paper strips were kept in the peri-implant pocket for 30 sec. Paper strips were placed in 500-µL sterilized Eppendorf® tubes to which phosphate-buffered saline (PBS) was added. All samples were kept at -40° until analysis. The enzyme-linked immunosorbent assay (ELISA) was used to measure OPG levels in the PICF samples in accordance with the manufacturer's instructions.

  6 months

Secondary Outcomes (3)

• Plaque index score (0-3)

  6 months

• Gingival index score (0-3)

  6 months

• Bleeding on probing (percentage)

  6 months

Study Arms (2)

Non-surgical mechanical therapy

ACTIVE COMPARATOR

Titanium curettes were used for non-surgical mechanical therapy in both groups under local anesthesia. The curette was gently inserted into the peri-implant pocket and the mechanical therapy was completed with threads felt. The control group received mechanical therapy alone.

Device: Non-surgical mechanical therapy

Er, Cr: YSGG laser-assisted non-surgical mechanical therapy

ACTIVE COMPARATOR

Titanium curettes were used for non-surgical mechanical therapy in both groups under local anesthesia. The curette was gently inserted into the peri-implant pocket and the mechanical therapy was completed with threads felt. The laser group received mechanical therapy followed by Er;Cr;YSGG laser.

Device: Er, Cr: YSGG laser-assisted non-surgical mechanical therapy

Interventions

Er, Cr: YSGG laser-assisted non-surgical mechanical therapy DEVICE

The laser group received mechanical therapy followed by Er;Cr;YSGG laser. Laser application was performed using the bottom-up technique. Therefore, the tip was retracted about 1 mm after it was placed on the bottom of the pocket and slowly moved in the coronal direction to the parallel to the implant surface.

Er, Cr: YSGG laser-assisted non-surgical mechanical therapy

Non-surgical mechanical therapy DEVICE

Traditional non surgical mechanical therapy Mechanical instrumentation in all groups was made with titanium curettes.The curette was gently inserted into the peri-implant pocket and the mechanical therapy was completed with threads felt.

Non-surgical mechanical therapy

Eligibility Criteria

• Age: 28 Years - 63 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Nazli Zeynep Alpaslan

Van, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34637055 RESULT

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Nazli Zeynep Alpaslan, PhD

  Yuzuncu Yil University

  PRINCIPAL INVESTIGATOR

• Dicle Altindal, PhD

  Yuzuncu Yil University

  STUDY CHAIR

• Damla Akbal, PhD

  Private Dental Clinic

  STUDY CHAIR

• Ahmet Cemil Talmac, PhD

  Yuzuncu Yil University

  STUDY CHAIR

• Serap Keskin Tunc, PhD

  Saglik Bilimleri Universitesi

  STUDY CHAIR

• Abdullah Seckin Ertugrul, PhD

  Izmir Katip Celebi University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD, Assoc. Prof. Dr

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 11, 2023
• Study Start: February 3, 2020
• Primary Completion: April 8, 2022
• Study Completion: April 8, 2022
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)