- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07446127
Adjunctive Diode Laser Therapy in Non-Surgical Periodontal Therapy
Evaluation of the Effect of Adjunctive Diode Laser Therapy in Mechanical Scaling and Root Surface Debridement in Non-Surgical Periodontal Therapy
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mahmoud Dr Younis, DMD
- Phone Number: +972544934823
- Email: younisma@hotmail.com
Study Locations
-
-
North
-
Afula, North, Israel, 1839203
- Recruiting
- Dr Younis Mahmoud
-
Contact:
- Mahmoud Dt Younis, DMD
- Phone Number: +972544934823
- Email: younisma@hotmail.com
-
Contact:
- Michael Dr Saminsky, DMD
- Phone Number: +972545508436
- Email: sachermiki@gmail.com
-
Principal Investigator:
- Michael Saminsky, DMD
-
Principal Investigator:
- Mahmoud Younis, DMD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: test quadrants
two contralateral jaw quadrants in each patient mouth will undergo RsD and Laser Diode assisted SRP treatment
|
Two quadrants will be treated mechanically (ScR) with adjunctive diode laser and another two quadrants mechanically (ScR) only
|
|
Active Comparator: control quadrants
two contralateral jaw quadrants in each patient mouth (same patient cohort) will undergo RsD treatment only
|
mechanical root surface debridement with periodontal curettes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PPD
Time Frame: prior to treatment and 12 weeks and 6 months after treatment
|
periodontal pocket depth
|
prior to treatment and 12 weeks and 6 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CAL
Time Frame: prior to treatment and 12 weeks and 6 months after the treatment
|
clinical attachment level
|
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
|
bleeding on probing
|
prior to treatment and 12 weeks and 6 months after the treatment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Pawelczyk-Madalinska M, Benedicenti S, Salagean T, Bordea IR, Hanna R. Impact of Adjunctive Diode Laser Application to Non-Surgical Periodontal Therapy on Clinical, Microbiological and Immunological Outcomes in Management of Chronic Periodontitis: A Systematic Review of Human Randomized Controlled Clinical Trials. J Inflamm Res. 2021 Jun 15;14:2515-2545. doi: 10.2147/JIR.S304946. eCollection 2021.
- Jia L, Jia J, Wu M, Li T, Zhao C, Shi H, Zhang X. Probing depth reduction of laser application in periodontal therapy: a network meta-analysis. Lasers Med Sci. 2022 Mar;37(2):1217-1226. doi: 10.1007/s10103-021-03376-0. Epub 2021 Jul 29.
- Gur AT, Guncu GN, Akman AC, Pinar A, Karabulut E, Nohutcu RM. Evaluation of GCF IL-17, IL-10, TWEAK, and sclerostin levels after scaling and root planing and adjunctive use of diode laser application in patients with periodontitis. J Periodontol. 2022 Aug;93(8):1161-1172. doi: 10.1002/JPER.21-0494. Epub 2022 Jan 25.
- Mokhtari MR, Ahrari F, Dokouhaki S, Fallahrastegar A, Ghasemzadeh A. Effectiveness of an 810-nm Diode Laser in Addition to Non-surgical Periodontal Therapy in Patients With Chronic Periodontitis: A Randomized Single-Blind Clinical Trial. J Lasers Med Sci. 2021 Jul 19;12:e37. doi: 10.34172/jlms.2021.37. eCollection 2021.
- Lu JW, Huang SH, Lei XX, Deng L, Luo LJ. Clinical outcomes of diode laser as an adjunct to nonsurgical periodontal therapy for residual periodontal pockets in mandibular second molars-a randomized controlled clinical trial. Clin Oral Investig. 2023 Aug;27(8):4493-4501. doi: 10.1007/s00784-023-05071-6. Epub 2023 May 23.
- Alizadeh Tabari Z, Pournasir L, Mohammadreza S, Anbari F. Clinical Efficacy of the 940-nm Diode Laser in the Treatment of Recurrent Pockets in the Periodontal Maintenance Phase. J Lasers Med Sci. 2021 Nov 6;12:e68. doi: 10.34172/jlms.2021.68. eCollection 2021.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0011601-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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