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OpenTrials
Completed

NCT Number: NCT04694222

Use of Laser Assisted New Attachment Procedure and Low Level Laser Therapy for Periodontitis Patients

In this study, it is evaluated the effects of laser assisted new attachment procedure (LANAP) and low level laser therapy (LLLT) and on clinical, biochemical and radiographic parameters in addition to non-surgical periodontal treatment (NSPT).

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Katip Celebi University

Izmir, 35000, Turkey (Türkiye)

About this study

The study was designed as a randomized-controlled, single-blind and parallel design consisting of 80 patients with chronic periodontitis. Study consists of 4 groups, with 20 patients in each group. Group 1 received only NSPT, Group 2 received NSPT+LANAP, Group 3 received NSPT+LLLT, and Group 4 received NSPT+LANAP+LLLT. Clinical measurements of patients and gingival crevicular fluid (GCF) were taken before treatment and after 1 and 3 months. In GCF, interleukin-1beta, interleukin-10 and vascular endothelial growth factor were analyzed. Standard periapical radiographs were taken for radiographic measurements.

In moderate (4-6 mm) and deep pockets (7 mm and above), it was found that all groups treated with laser significantly decrease pocket depth (PD) and clinic attachment level (CAL) compared to Group 1. Group 3 caused significantly less gingival recession than all other groups. There was no statistical difference between the groups in biochemical markers. Radiographic analysis revealed that only Group 2 achieved significant bone filling compared to Group 1.

Bot LANAP and LLLT application in the deep pockets provide an additional contribution to NSPT. It has been found that LLLT administration leads to decrease in PD by creating a minimum recession.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • periodontitis of periodontal stage II, III, or IV with grades B
  • with at least 12 teeth in the mouth and had ≥4 teeth but not all of them in the same quadrant
  • with Probing depth of ≥5 mm, Clinical attachment level of ≥4 mm
  • radiographic evidence of alveolar bone loss

Exclusion criteria

  • smoking
  • pregnancy and lactation
  • using antibiotics in the last 6 months and anti-inflammatory drugs in the last 3rd months,
  • having the systemic disease and the use of the drug that will affect the periodontal condition, having restoration of the adjacent tooth to be collected gingival crevicular fluid

Treatment and study plan

Nd:Yag Laser

Device

For LANAP, the fiber optic tip of the Nd:YAG laser (1064 nm) (Fotona Fidelis AT, USA) was used. For LLLT R24 biostimulation handpiece tip (950-μm) Nd:YAG laser (1064 nm) was used.

Primary outcomes

  1. Clinical attachment level gain

    Time frame: Baseline

    The clinical attachment level is determined by measuring the distance from the cemento-enamel junction to the gingival margin and adding the pocket depth to it.

  2. Clinical attachment level gain

    Time frame: 1 month

    The clinical attachment level is determined by measuring the distance from the cemento-enamel junction to the gingival margin and adding the pocket depth to it.

  3. Clinical attachment level gain

    Time frame: 3 month

    The clinical attachment level is determined by measuring the distance from the cemento-enamel junction to the gingival margin and adding the pocket depth to it.

Secondary outcomes

  1. Probing depth

    Time frame: Baseline

    It is determined by measuring the distance from the gingival margin to the pocket base

  2. Probing depth

    Time frame: 1 Month

    It is determined by measuring the distance from the gingival margin to the pocket base

  3. Probing depth

    Time frame: 3 Month

    It is determined by measuring the distance from the gingival margin to the pocket base

  4. Gingival index

    Time frame: Baseline

    For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues

  5. Gingival index

    Time frame: 1 Month

    For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues

  6. Gingival index

    Time frame: 3 Month

    For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues

  7. Plaque index

    Time frame: Baseline

    This index measures the thickness of plaque on gingival one third

  8. Plaque index

    Time frame: 1 Month

    This index measures the thickness of plaque on gingival one third

  9. Plaque index

    Time frame: 3 Month

    This index measures the thickness of plaque on gingival one third

  10. Bleeding on probing

    Time frame: Baseline

    In this index, probing is performed by gently walking around the pocket and bleeding is evaluated. As a result of probing, evaluation is made by looking at the presence or absence of bleeding in the gingiva.

  11. Bleeding on probing

    Time frame: 1 Month

    In this index, probing is performed by gently walking around the pocket and bleeding is evaluated. As a result of probing, evaluation is made by looking at the presence or absence of bleeding in the gingiva.

  12. Bleeding on probing

    Time frame: 3 Month

    In this index, probing is performed by gently walking around the pocket and bleeding is evaluated. As a result of probing, evaluation is made by looking at the presence or absence of bleeding in the gingiva.

  13. Interleukin-1beta

    Time frame: Baseline

    IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.

  14. Interleukin-1beta

    Time frame: 1 Month

    IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.

  15. Interleukin-1beta

    Time frame: 3 Month

    IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.

  16. Interleukin-10

    Time frame: Baseline

    IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.

  17. Interleukin-10

    Time frame: 1 Month

    IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.

  18. Interleukin-10

    Time frame: 3 Month

    IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.

  19. vascular endothelial growth factor (VEGF)

    Time frame: Baseline

    VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.

  20. vascular endothelial growth factor (VEGF)

    Time frame: 1 Month

    VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.

  21. vascular endothelial growth factor (VEGF)

    Time frame: 3 Month

    VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.

  22. Radiographic bone fill

    Time frame: Baseline

    The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.

  23. Radiographic bone fill

    Time frame: 1 Month

    The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.

  24. Radiographic bone fill

    Time frame: 3 Month

    The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Collaborators

  • Turkısh Medicines And Medical Devices Agency

Registry information

Official study title

Evaluation of Efficacy of LANAP and Adjunctive LLLT Application in the Treatment of Periodontitis: A Randomized Controlled Clinical Study

Acronym: LANAP LLLT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2021
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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