CClinicalTrials.gg
Not yet recruitingNCT07128134Updated Aug 17, 2025

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

An interventional study of Low Level Laser Therapy and Non-surgical Periodontal Treatment in Periimplantitis, sponsored by Mustafa Kemal University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-17.

Sponsored by Mustafa Kemal University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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. To examine the contributions of laser therapy to tissue healing by analyzing biochemical markers in peri-implant sulcular fluid over time.
Read the detailed description

This study will include volunteers who were diagnosed with peri-implantitis based on clinical and radiological examinations at the Department of Periodontology, Faculty of Dentistry, Hatay Mustafa Kemal University.

Seventy-two patients will be included in the study. In our study, patients will be divided into two groups. Thirty-six patients in the test group will receive low-level laser therapy in addition to non-surgical periodontal treatment. Thirty-six patients in the control group will receive only non-surgical periodontal treatment.

Periodontal indexes including plaque index, gingival index, bleeding on probing, probing pocket depth, and clinical attachment level will be recorded and peri-implant sulcus fluid will be collected from patients for routine diagnostic procedures. These measurements will be performed at baseline and at 1.5th and 3rd months by same researcher.

The following are required for a diagnosis of peri-implantitis:

  1. Evidence of visual inflammatory changes in the soft tissues around the implant, accompanied by bleeding and/or suppuration during probing
  2. Increased probing pocket depths compared to measurements obtained during the placement of the superstructure; and
  3. Progressive bone loss according to radiographic bone level assessment within 1 year after delivery of the implant-supported prosthetic reconstruction; and
  4. In cases where initial radiographs and probing depths are not available, a radiographic bone level of ≥3 mm and/or probing depths of ≥6 mm, along with the presence of bleeding, indicates peri-implantitis.

Study Treatment Protocol:

In the test group diagnosed with peri-implantitis, low-level laser therapy (LLLT) will be administered three times (on the same day as the initial treatment, on the 3rd day, and on the 7th day) in addition to non-surgical periodontal treatment by using A 940 nm indium gallium arsenide phosphor diode laser (Epic Biolase, Irvine, CA, USA).

PIOS regenerative (periostin) and inflammatory (vascular endothelial growth factor (VEGF), and interleukin-1 beta (IL-1ß)) biomarkers will be analyzed biochemically using the ELISA method (Enzyme-Linked Immunosorbent Assay) at the Department of Biochemistry, Faculty of Medicine, Hatay Mustafa Kemal University.

02

Conditions studied

  • Periimplantitis

Browse trials for

Keywords

  • Peri-implantitis
  • Laser therapy
  • Non-surgical treatment
03

In context

Peri-Implantitis

304 studies on the registry are indexed under Peri-Implantitis; 84 are open to participants now.

This study's planned enrollment of 72 is above the median of 40 across 182 interventional studies indexed under Peri-Implantitis.

Browse Peri-Implantitis studies →

Lead sponsor

Mustafa Kemal University is the lead sponsor of 71 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Laser treatment

    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

  • Active comparator
    Non-surgical treatment

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

    Procedure: Non-surgical Periodontal Treatment

Interventions

  • DeviceLow Level Laser Therapy

    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).

  • ProcedureNon-surgical Periodontal Treatment

    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).

06

What researchers measure

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

    Time frame: 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

    Periostin and vascular endothelial growth factor levels in peri-implant crevicular fluid will be measured before and after non-surgical treatment with or without adjunctive low-level laser therapy in peri-implantitis sites, using the ELISA immunoassay technique.

    Time frame: 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

    Interleukin-1 beta levels in peri-implant crevicular fluid will be measured before and after non-surgical treatment with or without adjunctive low-level laser therapy in peri-implantitis sites, using the ELISA immunoassay technique.

    Time frame: 0-3 month

07

Study locations

1 site
  • Hatay Mustafa Kemal University
    Hatay, 31000, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 27523046 ↗
  • Padial-Molina M, Volk SL, Taut AD, Giannobile WV, Rios HF. Periostin is down-regulated during periodontal inflammation. J Dent Res. 2012 Nov;91(11):1078-84. doi: 10.1177/0022034512459655. Epub 2012 Aug 29. PubMed 22933606 ↗
  • 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. PubMed 38358147 ↗
  • 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. PubMed 19128254 ↗
  • 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. PubMed 20932157 ↗
  • 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. PubMed 23161345 ↗
  • 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. PubMed 24656472 ↗
  • 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. PubMed 18980508 ↗
  • Wang CW, Renvert S, Wang HL. Nonsurgical Treatment of Periimplantitis. Implant Dent. 2019 Apr;28(2):155-160. doi: 10.1097/ID.0000000000000846. PubMed 30913111 ↗
  • Renvert S, Polyzois I, Claffey N. How do implant surface characteristics influence peri-implant disease? J Clin Periodontol. 2011 Mar;38 Suppl 11:214-22. doi: 10.1111/j.1600-051X.2010.01661.x. PubMed 21323717 ↗
  • 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. PubMed 19878469 ↗
  • 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. PubMed 26701919 ↗
  • Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350. PubMed 29926957 ↗
  • 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. PubMed 29926491 ↗
  • Schiegnitz E, Muller LK, Sagheb K, Theis L, Cagiran V, Kammerer PW, Wegener J, Wagner W, Al-Nawas B. Clinical long-term and patient-reported outcomes of dental implants in oral cancer patients. Int J Implant Dent. 2021 Jul 13;7(1):93. doi: 10.1186/s40729-021-00373-4. PubMed 34255187 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07128134
Lead sponsor
Mustafa Kemal University
Responsible party
Aysegul SARI (Associate professor, Mustafa Kemal University) — Principal investigator
First posted
Aug 17, 2025
Start date
Aug 20, 2025 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Aug 17, 2025

Study contacts

Mehmet A Gunenc, DDs
Contact
dtmehmetaligunenc@gmail.com
+0905076310563
Aysegul Sari, PhD
Contact
aysglsr@gmail.com
05321732518
Mehmet A Gunenc, DDs
principal investigator · Mustafa Kemal University
Aysegul Sari, PhD
study director · Mustafa Kemal University
Osman F Arpag, PhD
study chair · Mustafa Kemal University

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion