Evaluation of the Effects of the Low-level Laser Therapy as an Adjunct to Nonsurgical Treatment in Patients With Periimplantitis

NCT07128134 | Not Yet Recruiting FDA Device

• 2 other identifiers: KAEK-008-1/202525.DHU.006
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to evaluate the clinical efficacy of low-level laser therapy (LLLT) in addition to non-surgical periodontal treatment in patients with peri-implantitis. The study aims to investigate the anti-inflammatory and regenerative effects of low-level laser therapy on peri-implant soft and hard tissues and to reveal its contribution to treatment success. In this context, the specific objectives of the study are as follows:

1. 1.To evaluate the effects of LLLT added to non-surgical mechanical treatment on clinical parameters such as plaque index, probing depth, bleeding index, and clinical attachment level.
2. 2.To examine the contributions of laser therapy to tissue healing by analyzing biochemical markers in peri-implant sulcular fluid over time.

Conditions

Periimplantitis

Keywords

Peri-implantitis; Laser therapy; Non-surgical treatment

Outcome Measures

Primary Outcomes (1)

• Change in clinical peri-implant index values from baseline to the third months after non-surgical treatment with or without adjunctive low-level laser therapy

  In peri-implantitis sites, Plaque Index (Silness-Löe), Gingival Index (Löe-Silness), bleeding on probing, probing pocket depth, and clinical attachment level scores will be recorded before and after non-surgical treatment with or without adjunctive low-level laser therapy

  0-3 month

Secondary Outcomes (1)

• Change from baseline to the third months after non-surgical treatment with or without adjunctive low-level laser therapy in the regenerative biomarker levels in patients with peri-implantitis

  0-3 month

Other Outcomes (1)

• Change from baseline to the third months after non-surgical treatment with or without adjunctive low-level laser therapy in the inflammatory biomarker levels in patients with peri-implantitis

  0-3 month

Study Arms (2)

Laser treatment

EXPERIMENTAL

Laser Group: Group with peri-implantitis to receive low-level laser therapy in addition to non-surgical treatment of peri-implantitis)

Device: Low Level Laser Therapy; Procedure: Non-surgical Periodontal Treatment

Non-surgical treatment

ACTIVE COMPARATOR

Control group: Group with peri-implantitis who will undergo non-surgical treatment for peri-implantitis

Procedure: Non-surgical Periodontal Treatment

Interventions

Low Level Laser Therapy DEVICE

Although low-level laser therapy has been applied in cases of periodontitis, there are only a limited number of studies investigating its additional benefits in implants with peri-implantitis. This study aims to contribute to the literature on this subject. In addition to surgical periodontal treatment, low-level laser therapy (LLLT) was applied three times (on the same day as the initial treatment, on the third day, and on the seventh day) to the implants in the test group diagnosed with peri-implantitis. The 940 nm indium gallium arsenide phosphor diode laser (Epic Biolase, Irvine, CA, USA) will be applied perpendicular to the periodontal pocket for 20 seconds at a fixed distance of 15 mm and a continuous wavelength (3.41 J/cm2 application with a 1.76 cm2 spot and 0.3 W average output).

Laser treatment

Non-surgical Periodontal Treatment PROCEDURE

Peri-implantitis diagnosis will be made in the control group, and non-surgical periodontal treatment of implants will be performed using titanium curettes (Hu-Friedy, Chicago, IL, USA).

Laser treatment; Non-surgical treatment

Eligibility Criteria

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

You may qualify if:

• The patient must be willing to participate in the study.
• At least one implant with a pocket depth ≥ 6 mm and radiographic bone loss ≥ 3 mm diagnosed with peri-implantitis.
• Individuals aged 18-65.
• Patients who can understand and maintain oral hygiene education.

You may not qualify if:

• Individuals with any systemic disease that affects periodontal healing (diabetes, cancer, HIV/AIDS, acute infections, liver or kidney dysfunction/insufficiency, autoimmune disorders: rheumatoid arthritis, systemic lupus erythematosus, Hashimoto's thyroiditis)
• Female patients who are pregnant or breastfeeding
• Patients who have undergone periodontal treatment within the last six months
• Patients who have used antibiotics and regular anti-inflammatory medications within the last six months
• Use of medications that affect periodontal tissues (cyclosporine, phenytoin, sodium valproate, etc.).

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Hatay Mustafa Kemal University

Hatay, 31000, Turkey (Türkiye)

Location

Related Publications (15)

• Gundogar H, Senyurt SZ, Erciyas K, Yalim M, Ustun K. The effect of low-level laser therapy on non-surgical periodontal treatment: a randomized controlled, single-blind, split-mouth clinical trial. Lasers Med Sci. 2016 Dec;31(9):1767-1773. doi: 10.1007/s10103-016-2047-z. Epub 2016 Aug 14.

  PMID: 27523046 BACKGROUND

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  PMID: 22933606 BACKGROUND

• Santhosh VC, Karishma, Khader AA, Ramachandra V, Singh R, Shetty BK, Nimbalkar VK. Effect of periostin in peri-implant sulcular fluid and gingival crevicular fluid: A comparative study. Ann Afr Med. 2023 Oct-Dec;22(4):465-469. doi: 10.4103/aam.aam_171_22.

  PMID: 38358147 BACKGROUND

• Barrientos S, Stojadinovic O, Golinko MS, Brem H, Tomic-Canic M. Growth factors and cytokines in wound healing. Wound Repair Regen. 2008 Sep-Oct;16(5):585-601. doi: 10.1111/j.1524-475X.2008.00410.x.

  PMID: 19128254 BACKGROUND

• Aykol G, Baser U, Maden I, Kazak Z, Onan U, Tanrikulu-Kucuk S, Ademoglu E, Issever H, Yalcin F. The effect of low-level laser therapy as an adjunct to non-surgical periodontal treatment. J Periodontol. 2011 Mar;82(3):481-8. doi: 10.1902/jop.2010.100195. Epub 2010 Oct 8.

  PMID: 20932157 BACKGROUND

• Saglam M, Kantarci A, Dundar N, Hakki SS. Clinical and biochemical effects of diode laser as an adjunct to nonsurgical treatment of chronic periodontitis: a randomized, controlled clinical trial. Lasers Med Sci. 2014 Jan;29(1):37-46. doi: 10.1007/s10103-012-1230-0. Epub 2012 Nov 16.

  PMID: 23161345 BACKGROUND

• Carroll JD, Milward MR, Cooper PR, Hadis M, Palin WM. Developments in low level light therapy (LLLT) for dentistry. Dent Mater. 2014 May;30(5):465-75. doi: 10.1016/j.dental.2014.02.006. Epub 2014 Mar 21.

  PMID: 24656472 BACKGROUND

• Karlsson MR, Diogo Lofgren CI, Jansson HM. The effect of laser therapy as an adjunct to non-surgical periodontal treatment in subjects with chronic periodontitis: a systematic review. J Periodontol. 2008 Nov;79(11):2021-8. doi: 10.1902/jop.2008.080197.

  PMID: 18980508 BACKGROUND

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  PMID: 30913111 BACKGROUND

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  PMID: 21323717 BACKGROUND

• Tomasi C, Wennstrom JL. Full-mouth treatment vs. the conventional staged approach for periodontal infection control. Periodontol 2000. 2009;51:45-62. doi: 10.1111/j.1600-0757.2009.00306.x. No abstract available.

  PMID: 19878469 BACKGROUND

• Derks J, Schaller D, Hakansson J, Wennstrom JL, Tomasi C, Berglundh T. Effectiveness of Implant Therapy Analyzed in a Swedish Population: Prevalence of Peri-implantitis. J Dent Res. 2016 Jan;95(1):43-9. doi: 10.1177/0022034515608832.

  PMID: 26701919 BACKGROUND

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  PMID: 29926957 BACKGROUND

• Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.

  PMID: 29926491 BACKGROUND

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MeSH Terms

Conditions

Peri-Implantitis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Mehmet A Gunenc, DDs

  Mustafa Kemal University

  PRINCIPAL INVESTIGATOR

• Aysegul Sari, PhD

  Mustafa Kemal University

  STUDY DIRECTOR

• Osman F Arpag, PhD

  Mustafa Kemal University

  STUDY CHAIR

Central Study Contacts

Mehmet A Gunenc, DDs

CONTACT

+0905076310563; dtmehmetaligunenc@gmail.com

Aysegul Sari, PhD

CONTACT

05321732518; aysglsr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 17, 2025
• Study Start: August 20, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

TU (1)