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Recruiting NCT07446127

Adjunctive Diode Laser Therapy in Non-Surgical Periodontal Therapy

No phase Interventional Periodontal Disease Periodontal Pockets Periodontal Attachment Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LASER assisted SRP, RsD.
Who it may be relevant to
Registry conditions: Periodontal Disease, Periodontal Pockets, Periodontal Attachment Loss. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of the Effect of Adjunctive Diode Laser Therapy in Mechanical Scaling and Root Surface Debridement in Non-Surgical Periodontal Therapy

Overview

The goal of this clinical trial is to evaluate the efficacy of adjunctive application of diode laser to mechanical, non-surgical root surface debridement in patients attending periodontal office. The main question it aims to answer is: To compare the clinical effectiveness of adjunctive application of a 940-nm diode laser with root surface debridement to the effectiveness of root surface debridement alone. This study is a split-mouth design, where each quadrant will be randomly allocated to one of the following groups: Control group (root surface debridement - RsD): scaling and root planing alone. Laser group (RsD + laser): scaling and root planing with adjunctive diode laser therapy Quadrants will be randomly allocated to the treatment groups

Interventions

  • Device LASER assisted SRP
    Two quadrants will be treated mechanically (ScR) with adjunctive diode laser and another two quadrants mechanically (ScR) only
  • Device RsD
    mechanical root surface debridement with periodontal curettes

Primary outcome measures

  • PPD [Time frame: prior to treatment and 12 weeks and 6 months after treatment]
Secondary outcome measures (2)
  • CAL [Time frame: prior to treatment and 12 weeks and 6 months after the treatment]
  • BOP [Time frame: prior to treatment and 12 weeks and 6 months after the treatment]

Eligibility criteria

Inclusion criteria

  • Systemically healthy patients
  • Each patient should have more than 20 teeth remaining, and at least 5 teeth per quadrant
  • Each patient presented ≥ 30% of sites involved
  • At least 2 teeth with a probing depth of ≥ 5 mm in each quadrant, with evident radiographic bone loss.

Exclusion criteria

  • History of systemic diseases affecting the periodontium
  • Smokers and alcoholic patients
  • Use of medication within the last 6 months, which might affect the periodontal status
  • Pregnant and lactating women
  • Patients who had any periodontal treatment ≤ 12 months before the examination.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Israel · 1 center
  • Dr Younis Mahmoud — Afula

Publications

  • Schwarz F, Aoki A, Becker J, Sculean A. Laser application in non-surgical periodontal therapy: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):29-44. doi: 10.1111/j.1600-051X.2008.01259.x. PMID 18724840
  • Jia L, Jia J, Xie M, Zhang X, Li T, Shi L, Shi H, Zhang X. Clinical attachment level gain of lasers in scaling and root planing of chronic periodontitis: a network meta-analysis of randomized controlled clinical trials. Lasers Med Sci. 2020 Mar;35(2):473-485. doi: 10.1007/s10103-019-02875-5. Epub 2019 Nov 5. PMID 31691054
  • Moritz A, Gutknecht N, Doertbudak O, Goharkhay K, Schoop U, Schauer P, Sperr W. Bacterial reduction in periodontal pockets through irradiation with a diode laser: a pilot study. J Clin Laser Med Surg. 1997 Feb;15(1):33-7. doi: 10.1089/clm.1997.15.33. PMID 9467340
  • Aoki A, Sasaki KM, Watanabe H, Ishikawa I. Lasers in nonsurgical periodontal therapy. Periodontol 2000. 2004;36:59-97. doi: 10.1111/j.1600-0757.2004.03679.x. No abstract available. PMID 15330944
  • Gojkov-Vukelic M, Hadzic S, Dedic A, Konjhodzic R, Beslagic E. Application of a diode laser in the reduction of targeted periodontal pathogens. Acta Inform Med. 2013 Dec;21(4):237-40. doi: 10.5455/aim.2013.21.237-240. Epub 2013 Dec 4. PMID 24554796
  • Matarese G, Ramaglia L, Cicciu M, Cordasco G, Isola G. The Effects of Diode Laser Therapy as an Adjunct to Scaling and Root Planing in the Treatment of Aggressive Periodontitis: A 1-Year Randomized Controlled Clinical Trial. Photomed Laser Surg. 2017 Dec;35(12):702-709. doi: 10.1089/pho.2017.4288. Epub 2017 Sep 14. PMID 28945145
  • Dukic W, Bago I, Aurer A, Roguljic M. Clinical effectiveness of diode laser therapy as an adjunct to non-surgical periodontal treatment: a randomized clinical study. J Periodontol. 2013 Aug;84(8):1111-7. doi: 10.1902/jop.2012.110708. Epub 2012 Oct 17. PMID 23075433
  • De Micheli G, de Andrade AK, Alves VT, Seto M, Pannuti CM, Cai S. Efficacy of high intensity diode laser as an adjunct to non-surgical periodontal treatment: a randomized controlled trial. Lasers Med Sci. 2011 Jan;26(1):43-8. doi: 10.1007/s10103-009-0753-5. Epub 2010 Feb 4. PMID 20131073

Identifiers

NCT: NCT07446127 · 0011601-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗