Peri-ImplantitisNCT06031467

Er,Cr:YSGG Laser Application in Peri-implantitis

A study testing Er, Cr: YSGG laser-assisted non-surgical mechanical therapy and Non-surgical mechanical therapy in people with Peri-Implantitis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 28 to 63 yearsHealthy volunteers can take part
Conditions the study is for: Peri-Implantitis
What is being tested?: Er, Cr: YSGG laser-assisted non-surgical mechanical therapy and Non-surgical mechanical therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 3 Feb 2020to 8 Apr 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 28 to 63 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Nazli Zeynep Alpaslan
Van

Other trials in Turkey (Türkiye)

About this study

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

Read the 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.

Conditions: Peri-Implantitis
Being tested: Er, Cr: YSGG laser-assisted non-surgical mechanical therapy, Non-surgical mechanical therapy
Keywords: Er:Cr:YSGG, biomarkers, laser, osteoprotegerin, peri-implantitis, RANKL
Medical subject headings: Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Er, Cr: YSGG laser-assisted non-surgical mechanical therapyDevice
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.
Non-surgical mechanical therapyDevice
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.

Study groups in NCT06031467
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Er, Cr: YSGG laser-assisted non-surgical mechanical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 6 months

Secondary outcomes (3)

Plaque index score (0-3)
Plaque index was measured from the 4 surfaces of each implant. The plaque index score of each implant was calculated with Silness-Loe plaque index by dividing the total value by 4.
0:absence of microbial plaque
1. Thin film of microbial plaque along the free peri-implant margin
2. moderate accumulation with plaque in the sulcus
3. large amount of plaque in sulcus or pocket along the free peri-implant margin
Measured: 6 months
Gingival index score (0-3)
The gingival index was measured from the 4 surfaces of each implant. The gingival index score of each implant was calculated with Silness-Loe gingival index by dividing the total value by 4.
0:Normal gingiva
1. Mild inflammation: slight change in color, slight oedema, no bleeding on probing
2. Moderate inflammation: redness,oedema and glazing, bleeding on probing
3. Severe inflammation: marked redness and oedema, ulceration, tendency to spontaneous bleeding
Measured: 6 months
Bleeding on probing (percentage)
Bleeding on probing was measured from 4 surfaces of each implant. If there is bleeding after probing, it is recorded as +, if there is no bleeding it is recorded as _. Gingival bleeding index is calculated as a percentage of affected sites.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 20208 Apr 2022

First posted11 Sep 2023
Study start3 Feb 2020
Primary completion8 Apr 2022
Study completion8 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06031467
Sponsor's protocol ID: 29.01.2020/11
Status last verified: Sep 2023
First submitted: 4 Sep 2023
Last updated: 14 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34637055
Alpaslan NZ, Altindal D, Akbal D, Talmac AC, Keskin Tunc S, Ertugrul AS. Evaluation of the effect of Er,Cr:YSGG laser application on peri-implant crevicular fluid receptor activator of nuclear factor-kappa B ligand and osteoprotegerin levels in the non-surgical treatment of peri-implantitis: A randomized clinical trial. J Periodontol. 2024 Oct;95(10):917-928. doi: 10.1002/JPER.23-0540. Epub 2024 Feb 20.
PubMed 38375939

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peri-Implantitis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06031467
Acronym / sponsor ID: 29.01.2020/11
Conditions: Peri-Implantitis
Keywords: Er:Cr:YSGG, biomarkers, laser, osteoprotegerin, peri-implantitis, RANKL
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Yuzuncu Yil UniversityUniversity, hospital or other
Study start: 3 Feb 2020 (actual)
Primary completion: 8 Apr 2022 (actual)
Study completion: 8 Apr 2022 (actual)
First posted: 11 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Non-surgical mechanical therapy	Active comparator	Device: Non-surgical mechanical therapyTitanium 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.
Er, Cr: YSGG laser-assisted non-surgical mechanical therapy	Active comparator	Device: Er, Cr: YSGG laser-assisted non-surgical mechanical therapyTitanium 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.

Who may qualify

Ages: 28 to 63 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Er, Cr: YSGG laser-assisted non-surgical mechanical therapyThe 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.	Device	Er, Cr: YSGG laser-assisted non-surgical mechanical therapy
Non-surgical mechanical therapyTraditional 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.	Device	Non-surgical mechanical therapy

Primary outcome

Probing depth (mm)
Time frame: 6 months
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.
Receptor activator of nuclear factor-kappa B ligand (RANKL) level (pg/mL)
Time frame: 6 months
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.
Osteoprotegerin (OPG) level (ng/mL)
Time frame: 6 months
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.

3 secondary outcomes

Plaque index score (0-3)
Time frame: 6 months
Gingival index score (0-3)
Time frame: 6 months
Bleeding on probing (percentage)
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
Results publication: PubMed 34637055Alpaslan 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.
Derived from this study: PubMed 38375939Alpaslan NZ, Altindal D, Akbal D, Talmac AC, Keskin Tunc S, Ertugrul AS. Evaluation of the effect of Er,Cr:YSGG laser application on peri-implant crevicular fluid receptor activator of nuclear factor-kappa B ligand and osteoprotegerin levels in the non-surgical treatment of peri-implantitis: A randomized clinical trial. J Periodontol. 2024 Oct;95(10):917-928. doi: 10.1002/JPER.23-0540. Epub 2024 Feb 20.
Individual participant dataSharing planned: No

Related trials for Peri-Implantitis

Not yet recruiting
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Peri-Implantitis
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
RecruitingObservational study
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Peri-implantitis, Peri-implant Bone Loss
Not yet recruitingObservational study
ATR-FTIR and Raman Spectroscopy of Peri-Implant Crevicular Fluid in Peri-Implantitis
Peri-Implantitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nazli Zeynep Alpaslan, PhD principal investigator

Yuzuncu Yil University

Dicle Altindal, PhD study chair

Yuzuncu Yil University

Damla Akbal, PhD study chair

Private Dental Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Probing depth (mm) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06031467, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.