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PeriimplantitisNCT07128134

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

A study testing Low Level Laser Therapy and Non-surgical Periodontal Treatment in people with Periimplantitis, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Periimplantitis
What is being tested?
Low Level Laser Therapy and Non-surgical Periodontal Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Aug 2025to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mehmet A Gunenc, DDs contact

+0905076310563

dtmehmetaligunenc@gmail.com

Aysegul Sari, PhD contact

05321732518

aysglsr@gmail.com

Turkey (Türkiye)1 site
  • Hatay Mustafa Kemal University

    Hatay, 31000

    Aysegul Sari, PhD, 05321732518, aysglsr@gmail.com

    Mehmet Ali Gunenc, DDs, +905076310563, dtmehmetaligunenc@gmail.com

Other trials in Turkey (Türkiye)

About this study

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.

Conditions
Periimplantitis
Being tested
Low Level Laser Therapy, Non-surgical Periodontal Treatment
Keywords
Peri-implantitis, Laser therapy, Non-surgical treatment
Medical subject headings
Peri-Implantitis

What participants receive

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

  • Low Level Laser TherapyDevice

    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).

  • Non-surgical Periodontal TreatmentProcedure or surgery

    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).

Study groups in NCT07128134
Study groupRoleWhat they receive
Laser treatmentExperimentalLaser Group: Group with peri-implantitis to receive low-level laser therapy in addition to non-surgical treatment of peri-implantitis)
Receives: Device: Low Level Laser Therapy; Procedure: Non-surgical Periodontal Treatment
Non-surgical treatmentActive comparatorControl group: Group with peri-implantitis who will undergo non-surgical treatment for peri-implantitis
Receives: Procedure: Non-surgical Periodontal Treatment

What is being measured

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

  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

    Measured: 0-3 month

Secondary outcomes (1)
  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.

    Measured: 0-3 month

Timeline

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

  1. First posted17 Aug 2025
  2. Study start20 Aug 2025 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

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
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07128134
Sponsor's protocol ID
KAEK-008-1/2025
Other IDs
25.DHU.006
Status last verified
Aug 2025
First submitted
31 Jul 2025
Last updated
17 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

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

Questions about this trial

What is this clinical trial studying?

A study testing Low Level Laser Therapy and Non-surgical Periodontal Treatment in people with Periimplantitis, run by Mustafa Kemal 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Aug 2025. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Mehmet A Gunenc, DDs (+0905076310563, dtmehmetaligunenc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 0-3 month). 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 NCT07128134, which also lists 15 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 17 Aug 2025.

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