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PeriodontitisNCT05101603

Effects of Nd:YAG Laser and Air Abrasive Combined Application in Patients With Periodontitis

A study testing Air Abrasive, Nd:YAG Laser and Non surgical periodontal therapy in people with Periodontitis, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this clinical study is to investigate the effectiveness of the combined application of Nd:YAG (neodymium-doped yttrium aluminum garnet) laser and air abrasive applied in addition to nonsurgical periodontal treatment on clinical parameters in patients with periodontitis. Read more about this study

Who is it for?
Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Periodontitis
What is being tested?
Air Abrasive, Nd:YAG Laser and Non surgical periodontal therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2019to 1 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

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 20 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.),
  • Having a total of at least twenty permanent teeth in the mouth,
  • Non-smoker
  • Have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months,
  • Not in pregnancy or lactation period,
  • Patients who have not received periodontal treatment in the last 6 months,
Show all 11Show fewer
  • Patients who accepted the research and signed the informed volunteer consent form
  • Bleeding on probing in 30% or more areas,
  • 5 mm or more probing pocket depth in each quadrant in at least 2 non-adjacent teeth
  • 4mm or more attachment loss,
  • Coronal 1/3 or more (horizontal and/or vertical) on radiograph individuals with bone loss were included

Who cannot join

  • Having any systemic disease,
  • Regularly using a systemic medication,
  • Being pregnant or lactating.
  • To have had periodontal treatment in the last 6 months.
  • Receiving antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months.
  • Smoking.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Izmir Katip Celebi University Faculty of Dentistry

    Izmir, Çiğli, 35000

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Nd:YAG Laser and Air Abrasive Combined Application on Clinical Parameters in Addition to Non Surgical Periodontal Treatment in Patients With Periodontitis

The aim of this clinical study is to investigate the effectiveness of the combined application of Nd:YAG (neodymium-doped yttrium aluminum garnet) laser and air abrasive applied in addition to nonsurgical periodontal treatment on clinical parameters in patients with periodontitis.

A split-mouth, randomized study included 24 systemically healthy, non-smoker, periodontitis patients. In addition to non-surgical periodontal treatment, air abrasive (erythritol-chlorhexidine powder) and Nd:YAG laser (2 W, 200mJ, 10 Hz) combined application was applied to the test group, while only non-surgical periodontal treatment was applied to the control group. Clinical periodontal records of the patients, including plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PD), clinical attachment level (CAL), were taken before the treatment and at the 1st and 3rd months after the treatment.

All clinical parameters improved significantly from baseline for both groups after treatment (p˂0.05). In the evaluation between the test and control groups, no statistically significant difference was found in the PI, GI and BOP parameters of the patients at any time (p˃0.05). While the amount of change in PD and CAL values after treatment in medium deep pockets in the study groups was compared, no significant difference was observed between the groups (p˃0.05), statistically significant improvements in PD and CAL parameters were observed in the test group compared to the control group only for deep pockets (≥7 mm) among the groups (p˂0.05).In conclusion, it has been observed that the combined application of Nd:YAG laser and air abrasive in systemically healthy, stage III and grade C periodontitis patients is in the short term on PD and CAL, especially in inaccessible areas such as deep pockets.

Read the detailed description

Recently, erythritol has been introduced as a new air abrasive powder. Erythritol is a sugar alcohol. It is a water-soluble, chemically neutral artificial sweetener. Compared to glycine, another powder used in air abrasive devices, erythritol has a smaller particle size. Subgingival air abrasive application with erythritol has been shown to effectively remove subgingival biofilm from the root surface. In addition, erythritol has been reported to suppress bi-species biofilm formation of Porphyromonas gingivalis (p. gingivalis) and Streptococcus gordonii (s. gordonii) through ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) depletion and metabolic changes.

In recent years, lasers have gained increasing interest in the treatment of periodontitis as an adjunct or alternative treatment procedure to conventional treatment. It has been stated that the Nd:YAG laser provides excellent tissue ablation with strong bactericidal and detoxification effects, and it has been shown that it can reach deep pockets that conventional instruments cannot reach (7,19). It has been reported that Nd:YAG laser creates a very thick coagulation layer on soft tissue surfaces. It has also been proven that when applied to the pockets, it can remove the infected pocket epithelium. When applied in addition to non-surgical periodontal therapy, it has been shown to dramatically improve the clinical manifestations of periodontal inflammation compared to conventional therapy.

In this clinical study, it was aimed to clinically evaluate the effectiveness of subgingival Nd:YAG laser and air abrasive combined application in addition to non-surgical periodontal treatment in systemically healthy periodontitis patients. The efficacy of the combined Nd:YAG laser and air abrasive application was evaluated by examining the clinical periodontal parameters of the patients [plaque index (PI), probing pocket depth (PD), gingival index (GI), probing bleeding index (BI) and clinical attachment level (CAL)].

It is thought that, in addition to non-surgical periodontal treatment, YAG laser and air abrasive combined applications will have an antimicrobial effect on the biofilm in difficult areas and deep pockets that hand tools cannot reach, provide better penetration than irrigation fluids and contribute to periodontal regeneration. Thus, it is hoped to increase clinical success, prevent disease recurrences, reduce the need for periodontal surgery and increase the quality of life of patients.

Conditions
Periodontitis
Being tested
Air Abrasive, Nd:YAG Laser, Non surgical periodontal therapy
Keywords
Periodontitis, Non surgical periodontal treatment, Nd:YAG laser, Perioflow, Erythritol Powder
Medical subject headings
Periodontitis

What participants receive

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

  • Air AbrasiveDevice

    Also called EMS Dental Air-Flow® Handy Perio, Switzerland

    Applied with Nd:YAG Laser on periodontal pockets

  • Nd:YAG LaserDevice

    Also called Fotona Fidelis AT, Ljubljana, SLOVENIA

    Applied with Air Abrasive on periodontal pockets

  • Non surgical periodontal therapyProcedure or surgery

    The first phase, in which optimum plaque control is achieved and local etiological factors are removed, is the first step of all periodontal diseases and surgical procedures.

Study groups in NCT05101603
Study groupRoleWhat they receive
ControlActive comparatorOnly non surgical periodontal treatment
Receives: Procedure: Non surgical periodontal therapy
TestExperimentalNd:YAG Laser and air abrasive combined application addition to non surgical periodontal treatment
Receives: Device: Air Abrasive; Device: Nd:YAG Laser; Procedure: Non surgical periodontal therapy

What is being measured

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

  1. Clinical attachment level change

    With the help of a Williams periodontal probe, the distance between the enamel-cementum border and the sulcus/pocket floor will be measured from the six points of the tooth: mesiobuccal, midbuccal, distobuccal, mesiopalatal/lingual, mid-buccal/palatal and distobuccal/palatal.

    Measured: Change from baseline clinical attachment level at 3 months

Timeline

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

  1. First posted1 Nov 2021
  2. Study start1 Sep 2019
  3. Primary completion1 Sep 2020
  4. Study completion1 Sep 2020

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
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05101603
Sponsor's protocol ID
IsmetIlke
Status last verified
Oct 2021
First submitted
7 Oct 2021
Last updated
1 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hagi TT, Hofmanner P, Salvi GE, Ramseier CA, Sculean A. Clinical outcomes following subgingival application of a novel erythritol powder by means of air polishing in supportive periodontal therapy: a randomized, controlled clinical study. Quintessence Int. 2013 Nov-Dec;44(10):753-61. doi: 10.3290/j.qi.a30606.

    PubMed 24078975
  • Hashino E, Kuboniwa M, Alghamdi SA, Yamaguchi M, Yamamoto R, Cho H, Amano A. Erythritol alters microstructure and metabolomic profiles of biofilm composed of Streptococcus gordonii and Porphyromonas gingivalis. Mol Oral Microbiol. 2013 Dec;28(6):435-51. doi: 10.1111/omi.12037. Epub 2013 Jul 29.

    PubMed 23890177
  • Crespi R, Covani U, Margarone JE, Andreana S. Periodontal tissue regeneration in beagle dogs after laser therapy. Lasers Surg Med. 1997;21(4):395-402. doi: 10.1002/(sici)1096-9101(1997)21:43.0.co;2-a.

    PubMed 9328987
  • Ting CC, Fukuda M, Watanabe T, Sanaoka A, Mitani A, Noguchi T. Morphological alterations of periodontal pocket epithelium following Nd:YAG laser irradiation. Photomed Laser Surg. 2014 Dec;32(12):649-57. doi: 10.1089/pho.2014.3793.

    PubMed 25392971
  • Gold SI, Vilardi MA. Pulsed laser beam effects on gingiva. J Clin Periodontol. 1994 Jul;21(6):391-6. doi: 10.1111/j.1600-051x.1994.tb00735.x.

    PubMed 8089240
  • Qadri T, Poddani P, Javed F, Tuner J, Gustafsson A. A short-term evaluation of Nd:YAG laser as an adjunct to scaling and root planing in the treatment of periodontal inflammation. J Periodontol. 2010 Aug;81(8):1161-6. doi: 10.1902/jop.2010.090700.

    PubMed 20397904
  • Nagy RJ, Otomo-Corgel J, Stambaugh R. The effectiveness of scaling and root planing with curets designed for deep pockets. J Periodontol. 1992 Dec;63(12):954-9. doi: 10.1902/jop.1992.63.12.954.

    PubMed 1474467
  • 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 Clin Periodontol. 2018 Jun;45 Suppl 20:S162-S170. doi: 10.1111/jcpe.12946.

    PubMed 29926490
  • Badersten A, Nilveus R, Egelberg J. Effect of nonsurgical periodontal therapy. II. Severely advanced periodontitis. J Clin Periodontol. 1984 Jan;11(1):63-76. doi: 10.1111/j.1600-051x.1984.tb01309.x.

    PubMed 6363463
  • Drisko CH. Nonsurgical periodontal therapy. Periodontol 2000. 2001;25:77-88. doi: 10.1034/j.1600-0757.2001.22250106.x.

    PubMed 11155183
  • Petersilka GJ, Bell M, Mehl A, Hickel R, Flemmig TF. Root defects following air polishing. J Clin Periodontol. 2003 Feb;30(2):165-70. doi: 10.1034/j.1600-051x.2003.300204.x.

    PubMed 12622860
  • Petersilka G. Re: "Subgingival plaque removal using a new air-polishing device". Moene R, Decaillet F, Andersen E, Mombelli A. (J Periodontol 2010;81:79-88.). J Periodontol. 2010 Jul;81(7):962-3. doi: 10.1902/jop.2010.100118. No abstract available.

    PubMed 20553116
  • Cobb CM, Daubert DM, Davis K, Deming J, Flemmig TF, Pattison A, Roulet JF, Stambaugh RV. Consensus Conference Findings on Supragingival and Subgingival Air Polishing. Compend Contin Educ Dent. 2017 Feb;38(2):e1-e4.

    PubMed 28156118
  • Munro IC, Berndt WO, Borzelleca JF, Flamm G, Lynch BS, Kennepohl E, Bar EA, Modderman J. Erythritol: an interpretive summary of biochemical, metabolic, toxicological and clinical data. Food Chem Toxicol. 1998 Dec;36(12):1139-74. doi: 10.1016/s0278-6915(98)00091-x.

    PubMed 9862657

Questions about this trial

What is this clinical trial studying?

A study testing Air Abrasive, Nd:YAG Laser and Non surgical periodontal therapy in people with Periodontitis, run by Izmir Katip Celebi 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 11 inclusion and 6 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: finished, as of the sponsor's last update on 1 Nov 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical attachment level change (time frame: Change from baseline clinical attachment level at 3 months). 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 NCT05101603, which also lists 14 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 1 Nov 2021.

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