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Periodontitis (Stage 3)NCT07851584

Er,Cr:YSGG Laser in Smokers With Stage III Periodontitis

A study testing Nonsurgical Periodontal Therapy and Nonsurgical Periodontal Therapy + Er,Cr:YSGG Laser in people with Periodontitis (Stage 3), run by Okan 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

Periodontitis is an inflammatory disease that affects the tissues supporting the teeth. If the disease progresses, it can cause loss of the tissues and bone around the teeth and lead to the formation of deep spaces, called periodontal pockets, between the teeth and gums. Read more about this study

Who is it for?
Ages 35 to 65 years
Conditions the study is for
Periodontitis (Stage 3)
What is being tested?
Nonsurgical Periodontal Therapy and Nonsurgical Periodontal Therapy + Er,Cr:YSGG Laser
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2025to 1 Aug 2026
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 35 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 35 and 65 years
  • Systemically healthy status
  • Smoking ≥10 cigarettes/day for at least 5 years
  • Diagnosis of Stage III Grade C periodontitis according to the 2017 classification
  • Stage III classification based on periodontal tissue destruction, with interdental clinical attachment loss ≥5 mm
  • Presence of contralateral study sites suitable for split-mouth allocation, with clinical attachment loss ≥5 mm at both test and control sites
Show all 9Show fewer
  • Presence of contralateral interdental regions between premolar teeth, without tooth loss, suitable for split-mouth allocation
  • No antibiotic use within the previous 3 months
  • No periodontal treatment within the previous 6 months

Who cannot join

  • Systemic disease or condition affecting periodontal status, wound healing, or bone metabolism
  • Pregnancy or lactation
  • Non-smoker or smoking <10 cigarettes/day
  • Gingivitis
  • Stage I, Stage II, or Stage IV periodontitis
  • Grade A or Grade B periodontitis
Show all 10Show fewer
  • No suitable contralateral study sites for split-mouth allocation, defined as CAL ≥5 mm and PPD ≥5 mm at both test and control sites
  • Tooth loss in the selected interdental regions between premolar teeth planned for test or control allocation
  • Antibiotic use within the previous 3 months
  • Periodontal therapy within the previous 6 months

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Okan University Faculty of Dentistry Department of Periodontology

    Istanbul, Tuzla

Other trials in Turkey (Türkiye)

About this study

Official title: Clinical, Radiographic, and Biochemical Outcomes of Er,Cr:YSGG Laser-Assisted Nonsurgical Periodontal Therapy in Smokers With Stage III Grade C Periodontitis: A Split-Mouth Randomized Controlled Trial

Periodontitis is an inflammatory disease that affects the tissues supporting the teeth. If the disease progresses, it can cause loss of the tissues and bone around the teeth and lead to the formation of deep spaces, called periodontal pockets, between the teeth and gums. The main treatment for periodontitis is to improve oral hygiene and remove bacterial deposits and calculus from the tooth and root surfaces.

Smoking is an important risk factor for periodontitis and may reduce the response to periodontal treatment by negatively affecting tissue healing. For this reason, additional treatments that may improve healing in smokers are being investigated. One of these approaches is the use of dental lasers together with conventional nonsurgical periodontal treatment.

Read more

The purpose of this study is to investigate whether adding Er,Cr:YSGG laser treatment to nonsurgical periodontal therapy improves treatment outcomes in systemically healthy smokers with Stage III periodontitis.

This study will use a split-mouth design, meaning that two different treatments will be compared within the same participant. One side of the mouth will receive conventional nonsurgical periodontal treatment, including scaling and root surface instrumentation. The other side will receive the same treatment together with Er,Cr:YSGG laser application. Changes in gum health, periodontal pocket depth, bone-related findings on radiographs, and biological markers related to bone metabolism will be evaluated during follow-up.

The study hypothesis is that adding Er,Cr:YSGG laser treatment to conventional nonsurgical periodontal therapy will provide additional clinical, radiographic, and biochemical benefits compared with conventional nonsurgical periodontal therapy alone in smokers with Stage III periodontitis.

Read the detailed description

Periodontitis is a chronic multifactorial inflammatory disease associated with dental biofilm and characterized by progressive destruction of the tooth-supporting tissues, including clinical attachment loss and alveolar bone loss. Smoking is an important modifiable risk factor for periodontitis and may adversely affect the host inflammatory response, periodontal wound healing, and bone metabolism. In the 2017 classification of periodontal diseases, smoking is considered an important modifier in determining the grade of periodontitis.

Non-surgical periodontal therapy is the first-line approach for controlling periodontal inflammation through disruption and removal of subgingival biofilm and calculus. However, complete instrumentation may be difficult in deep periodontal pockets and anatomically complex areas. These limitations have led to the investigation of adjunctive treatment approaches that may enhance the clinical and biological response to conventional non-surgical periodontal therapy.

Erbium lasers have been investigated as adjunctive tools in periodontal treatment because of their interaction with water-containing soft and hard tissues and their ability to ablate periodontal tissues and calculus with limited thermal damage when appropriate parameters are used. The Er,Cr:YSGG laser may provide additional effects through pocket decontamination, removal of diseased pocket epithelium and granulation tissue, root surface treatment, and modulation of the local healing environment.

Periodontal treatment response may also be evaluated using biological markers associated with bone remodeling. Receptor activator of nuclear factor-kappa B ligand (RANKL) promotes osteoclast differentiation and bone resorption, whereas osteoprotegerin (OPG) acts as a decoy receptor for RANKL and inhibits osteoclast activation. Sclerostin is an osteocyte-derived protein involved in the regulation of bone formation. Assessment of these biomarkers in gingival crevicular fluid may provide additional information regarding the biological response to periodontal treatment. In addition, radiographic fractal analysis may provide a quantitative assessment of trabecular bone architecture that may not be reflected by conventional linear bone measurements.

This randomized split-mouth clinical trial evaluates the adjunctive effect of Er,Cr:YSGG laser therapy in smokers with Stage III Grade C periodontitis. Contralateral regions are selected as test and control sites to reduce the influence of interindividual factors such as smoking exposure, host response, and oral hygiene behavior. Both sides receive non-surgical periodontal therapy, while the test side additionally receives Er,Cr:YSGG laser treatment according to a standardized periodontal protocol.

Treatment response is assessed using clinical periodontal measurements together with gingival crevicular fluid biomarkers and standardized radiographic analyses during follow-up. The combined evaluation of clinical, biochemical, and radiographic changes is intended to provide a multidimensional assessment of the possible adjunctive effects of Er,Cr:YSGG laser therapy in a high-risk periodontal population.

The aim of this randomized split-mouth clinical trial is to evaluate the adjunctive effects of Er,Cr:YSGG laser therapy on clinical periodontal parameters, gingival crevicular fluid biomarkers related to bone metabolism, and radiographic bone changes in smokers with Stage III Grade C periodontitis receiving non-surgical periodontal therapy. The study hypothesis is that adjunctive Er,Cr:YSGG laser therapy will produce differences in clinical, biochemical, and radiographic outcomes compared with non-surgical periodontal therapy alone.

Being tested
Nonsurgical Periodontal Therapy, Nonsurgical Periodontal Therapy + Er,Cr:YSGG Laser
Keywords
periodontal debridement, Erbium; Laser therapy, RANK ligand, Sclerostin, Osteoprotegerin, smoking
Medical subject headings
Periodontitis, Sclerosteosis, Smoking

What participants receive

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

  • Nonsurgical Periodontal TherapyProcedure or surgery

    Nonsurgical periodontal therapy will consist of oral hygiene instructions followed by supra- and subgingival scaling and root surface instrumentation. Periodontal instrumentation will be performed using ultrasonic and hand instruments as required until the root surfaces are considered adequately debrided. No adjunctive laser treatment will be applied to sites allocated to the control side.

  • Nonsurgical Periodontal Therapy + Er,Cr:YSGG LaserProcedure or surgery

    Following nonsurgical periodontal therapy, sites allocated to the experimental side will receive adjunctive Er,Cr laser treatment. The laser will be applied into the periodontal pockets according to a standardized protocol using predefined laser parameters and an appropriate periodontal tip. Laser irradiation will be performed along the treated periodontal pocket sites as an adjunct to conventional scaling and root surface instrumentation.

Study groups in NCT07851584
Study groupRoleWhat they receive
Nonsurgical Periodontal TherapyActive comparatorParticipants will receive nonsurgical periodontal therapy consisting of scaling and root surface instrumentation on the sites allocated to the control side. No adjunctive laser treatment will be applied to these sites.
Receives: Procedure: Nonsurgical Periodontal Therapy
Nonsurgical Periodontal Therapy + Er,Cr:YSGG LaserExperimentalParticipants will receive nonsurgical periodontal therapy consisting of scaling and root surface instrumentation on the sites allocated to the experimental side, followed by adjunctive Er,Cr:YSGG laser application.
Receives: Procedure: Nonsurgical Periodontal Therapy; Procedure: Nonsurgical Periodontal Therapy + Er,Cr:YSGG Laser

What is being measured

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

  1. Change in Clinical Attachment Level

    Clinical attachment level was measured in millimeters from the cementoenamel junction to the base of the periodontal pocket using a periodontal probe. Higher values indicate greater periodontal attachment loss. A reduction in clinical attachment level from baseline indicates clinical attachment gain and periodontal improvement.

    Measured: Baseline, 6 weeks, 3 months, 6 months, 9 months, and 12 months

Secondary outcomes (1)
  1. Change in Probing Pocket Depth

    Measured: Baseline, 6 weeks, 3 months, 6 months, 9 months, and 12 months

Timeline

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

  1. First posted1 Oct 2026
  2. Study start1 Feb 2025
  3. Primary completion1 Aug 2026
  4. Study completion1 Aug 2026

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07851584
Sponsor's protocol ID
668
Other IDs
E-61749811-000-2805802
Status last verified
Sep 2026
First submitted
25 Sep 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the main results of the study are planned to be made available from the corresponding author upon reasonable request after completion of the study and publication of the main results.

Publications

  • Park JS, Jung H, Ryu JJ, Koo KT, Lee J. Effect of erbium, chromium-doped: yttrium, scandium, gallium, and garnet laser-assisted periodontal therapy using radial firing tip during early healing period: a randomized controlled split-mouth clinical trial. BMC Oral Health. 2024 May 8;24(1):539. doi: 10.1186/s12903-024-04270-1.

    PubMed 38720276
  • Updike SX, Nowzari H. Fractal analysis of dental radiographs to detect periodontitis-induced trabecular changes. J Periodontal Res. 2008 Dec;43(6):658-64. doi: 10.1111/j.1600-0765.2007.01056.x. Epub 2008 Jun 24.

    PubMed 18624949
  • Balli U, Aydogdu A, Dede FO, Turer CC, Guven B. Gingival Crevicular Fluid Levels of Sclerostin, Osteoprotegerin, and Receptor Activator of Nuclear Factor-kappaB Ligand in Periodontitis. J Periodontol. 2015 Dec;86(12):1396-404. doi: 10.1902/jop.2015.150270. Epub 2015 Sep 14.

    PubMed 26367496
  • Belibasakis GN, Bostanci N. The RANKL-OPG system in clinical periodontology. J Clin Periodontol. 2012 Mar;39(3):239-48. doi: 10.1111/j.1600-051X.2011.01810.x. Epub 2011 Oct 24.

    PubMed 22092994
  • Klokkevold PR, Damian A, Pham C, Mallya SM, Lux R. Clinical evaluation of Er,Cr:YSGG laser therapy used as an adjunct to non-surgical treatment of periodontitis: Twelve-month results from a pilot study. J Periodontol. 2022 Sep;93(9):1314-1324. doi: 10.1002/JPER.21-0443. Epub 2022 Mar 24.

    PubMed 35239185
  • Cobb CM. Lasers in periodontics: a review of the literature. J Periodontol. 2006 Apr;77(4):545-64. doi: 10.1902/jop.2006.050417.

    PubMed 16584335
  • Suvan J, Leira Y, Moreno Sancho FM, Graziani F, Derks J, Tomasi C. Subgingival instrumentation for treatment of periodontitis. A systematic review. J Clin Periodontol. 2020 Jul;47 Suppl 22:155-175. doi: 10.1111/jcpe.13245.

    PubMed 31889320
  • Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.

    PubMed 32383274
  • Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945.

    PubMed 29926495
  • Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.

    PubMed 29926951

Questions about this trial

What is this clinical trial studying?

A study testing Nonsurgical Periodontal Therapy and Nonsurgical Periodontal Therapy + Er,Cr:YSGG Laser in people with Periodontitis (Stage 3), run by Okan University at 1 site in Turkey (Türkiye).

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 9 inclusion and 10 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 1 Oct 2026. 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?

Change in Clinical Attachment Level (time frame: Baseline, 6 weeks, 3 months, 6 months, 9 months, and 12 months). 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 NCT07851584, which also lists 10 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 1 Oct 2026.

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