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

NCT07851584 | Completed

• 2 other identifiers: 668E-61749811-000-2805802
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Periodontitis (Stage 3)

Keywords

periodontal debridement; Erbium; Laser therapy; RANK ligand; Sclerostin; Osteoprotegerin; smoking

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Change in Probing Pocket Depth

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

Other Outcomes (3)

• Change in Radiographic Alveolar Bone Level

  Baseline, 6 months, 9 months, and 12 months

• Change in Gingival Crevicular Fluid RANKL Level

  Baseline, 6 weeks, 3 months

• Change in Gingival Crevicular Fluid Sclerostin Level

  Baseline, 6 weeks, 3 months

Study Arms (2)

Nonsurgical Periodontal Therapy

ACTIVE COMPARATOR

Participants 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.

Procedure: Nonsurgical Periodontal Therapy

Nonsurgical Periodontal Therapy + Er,Cr:YSGG Laser

EXPERIMENTAL

Participants 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.

Procedure: Nonsurgical Periodontal Therapy; Procedure: Nonsurgical Periodontal Therapy + Er,Cr:YSGG Laser

Interventions

Nonsurgical Periodontal Therapy PROCEDURE

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; Nonsurgical Periodontal Therapy + Er,Cr:YSGG Laser

Nonsurgical Periodontal Therapy + Er,Cr:YSGG Laser PROCEDURE

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.

Nonsurgical Periodontal Therapy + Er,Cr:YSGG Laser

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Istanbul Okan University Faculty of Dentistry Department of Periodontology

Istanbul, Tuzla, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 38720276 BACKGROUND

• 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.

  PMID: 18624949 BACKGROUND

• 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.

  PMID: 26367496 BACKGROUND

• 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.

  PMID: 22092994 BACKGROUND

• 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.

  PMID: 35239185 BACKGROUND

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

  PMID: 16584335 BACKGROUND

• 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.

  PMID: 31889320 BACKGROUND

• 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.

  PMID: 32383274 BACKGROUND

• 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.

  PMID: 29926495 BACKGROUND

• 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.

  PMID: 29926951 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Sclerosteosis; Smoking

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Behavior

Study Officials

• Gokce Aykol Sahin, PhD

  Okan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to treatment allocation. The clinician performing the Er,Cr laser application cannot be blinded because of the nature of the intervention. Participants may also be aware of the laser application. Clinical, radiographic, and biochemical outcome assessments will be performed without knowledge of which side received adjunctive laser treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: February 1, 2025
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication of the main results and for 3 years
• Access Criteria: Upon reasonable request, with methodologically sound proposal, subject to institutional/ethical approval if required.

Locations

TU (1)