NCT05101603

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

October 7, 2021

Last Update Submit

October 19, 2021

Conditions

Keywords

PeriodontitisNon surgical periodontal treatmentNd:YAG laserPerioflowErythritol Powder

Outcome Measures

Primary Outcomes (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.

    Change from baseline clinical attachment level at 3 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Only non surgical periodontal treatment

Procedure: Non surgical periodontal therapy

Test

EXPERIMENTAL

Nd:YAG Laser and air abrasive combined application addition to non surgical periodontal treatment

Device: Air AbrasiveDevice: Nd:YAG LaserProcedure: Non surgical periodontal therapy

Interventions

Applied with Nd:YAG Laser on periodontal pockets

Also known as: EMS Dental Air-Flow® Handy Perio, Switzerland
Test

Applied with Air Abrasive on periodontal pockets

Also known as: Fotona Fidelis AT, Ljubljana, SLOVENIA
Test

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.

ControlTest

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • Patients who accepted the research and signed the informed volunteer consent form
  • Bleeding on probing in 30% or more areas,
  • mm or more probing pocket depth in each quadrant in at least 2 non-adjacent teeth
  • mm or more attachment loss,
  • Coronal 1/3 or more (horizontal and/or vertical) on radiograph individuals with bone loss were included

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University Faculty of Dentistry

Izmir, Çiğli, 35000, Turkey (Türkiye)

Location

Related Publications (14)

  • 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.

    PMID: 24078975BACKGROUND
  • 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.

    PMID: 23890177BACKGROUND
  • 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.

    PMID: 9328987BACKGROUND
  • 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.

    PMID: 25392971BACKGROUND
  • 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.

    PMID: 8089240BACKGROUND
  • 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.

    PMID: 20397904BACKGROUND
  • 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.

    PMID: 1474467BACKGROUND
  • 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.

    PMID: 29926490BACKGROUND
  • 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.

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

    PMID: 11155183BACKGROUND
  • 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.

    PMID: 12622860BACKGROUND
  • 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.

    PMID: 20553116BACKGROUND
  • 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.

    PMID: 28156118BACKGROUND
  • 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.

    PMID: 9862657BACKGROUND

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Mehmet Sağlam

    Izmir Katip Celebi University Faculty of Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Dentist

Study Record Dates

First Submitted

October 7, 2021

First Posted

November 1, 2021

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

November 1, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations