Diode Laser as an Adjunct to Professional Mechanical Plaque Removal

NCT06719674 | Active Not Recruiting DMC

• 1 other identifier: USulaimani/SGUL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will utilize diode laser to determine its effects on improving periodontal parameters and inflammatory biomarkers, comparing with conventional treatment alone, and evaluate its effectiveness in improving periodontal disease's clinical parameters. Several studies have compared the effects of lasers and conventional periodontal treatment, comparing only its microbiological and clinical parameter levels and therapy to determine their effectiveness in key periodontal pathogens eradication and their effects on improving the clinical parameters of periodontal disease, in this study, salivary biomarkers will be collected and assessed to do a comparison between two treatment modalities. To the best of our knowledge, this is the first study to examine the effect of diode lasers on salivary biomarker levels.

Conditions

Periodontitis; Pocket, Periodontal

Keywords

Non surgical periodontal therapy; Diode laser; Salivary biomarkers

Outcome Measures

Primary Outcomes (1)

• Reduction in probing pocket depth (mm)

  Probing pocket depth determined from the gingival margin to the base of the pocket at six sites per tooth.

  3 months

Secondary Outcomes (1)

• Biomarkers level in pg/ML: (interleukin (IL)-1beta), Matrix metalloproteinases (MMP 8) and (TIMP), RANK.

  3 months

Study Arms (2)

Professional Mechanical Plaque Removal + Laser

EXPERIMENTAL

The patients will be treated in accordance with treatment guidelines for Stage III periodontitis issued by the European Federation of Periodontology. At baseline, oral hygiene instructions were given together with supra- and subgingival professional mechanical plaque removal (PMPR) using a combination of the ultrasonic scaler and hand instruments plus diode laser, according to the clinical situation. After completing treatment, patients will be asked to return at 1 month for review and again at 3 months to repeat the measurement of clinical parameters and collection of the saliva samples.

Procedure: Professional mechanical plaque removal and Laser

Professional Mechanical Plaque Removal

ACTIVE COMPARATOR

The patients will be treated in accordance with treatment guidelines for Stage III periodontitis issued by the European Federation of Periodontology (13). At baseline, oral hygiene instructions were given together with supra- and subgingival professional mechanical plaque removal (PMPR) using a combination of the ultrasonic scaler and hand instruments, according to the clinical situation. After completing treatment, patients will be asked to return at 1 month for review and again at 3 months to repeat the measurement of clinical parameters and collection of the saliva samples.

Procedure: Professional mechanical plaque removal

Interventions

Professional mechanical plaque removal and Laser PROCEDURE

A diode laser will be used as an adjunct to mechanical plaque removal.

Also known as: EPIC 10S Soft Tissue Diode Laser, Photodynamic therapy

Professional Mechanical Plaque Removal + Laser

Professional mechanical plaque removal PROCEDURE

The patients will be treated in accordance with treatment guidelines for Stage III periodontitis issued by the European Federation of Periodontology (13). At baseline, oral hygiene instructions were given together with supra- and subgingival professional mechanical plaque removal (PMPR) using a combination of the ultrasonic scaler and hand instruments, according to the clinical situation. After completing treatment, patients will be asked to return at 1 month for review and again at 3 months to repeat the measurement of clinical parameters and collection of the saliva samples.

Professional Mechanical Plaque Removal

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with periodontitis.
• Patients having at least 3 teeth with PPD of 5 mm and above.

You may not qualify if:

• Patients with diabetes
• Patients on medication with an inhibitory or promoting effect on periodontal healing, including anticoagulants, anti-inflammatory drugs.
• Patients received antibiotics within the last three months.
• Pregnant or nursing women
• Patients receiving periodontal therapy within the last 3 months

Sponsors & Collaborators

• Sulaimani Polytechnic University: collaborator
• University of Sulaimani: lead
• University of Dundee: collaborator

Study Sites (1)

College of Dentistry, University of Sulaimani

Sulaymaniyah, 46001, Iraq

Location

Related Publications (12)

• 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 Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.

  PMID: 29926951 BACKGROUND

• Shaddox LM, Walker CB. Treating chronic periodontitis: current status, challenges, and future directions. Clin Cosmet Investig Dent. 2010 Aug 11;2:79-91. Print 2010.

  PMID: 23662085 BACKGROUND

• Ravida A, Qazi M, Rodriguez MV, Galli M, Saleh MHA, Troiano G, Wang HL. The influence of the interaction between staging, grading and extent on tooth loss due to periodontitis. J Clin Periodontol. 2021 May;48(5):648-658. doi: 10.1111/jcpe.13430. Epub 2021 Mar 19.

  PMID: 33484162 BACKGROUND

• Ciantar M. Time to shift: from scaling and root planing to root surface debridement. Prim Dent J. 2014 Aug;3(3):38-42. doi: 10.1308/205016814812736592.

  PMID: 25198637 BACKGROUND

• Keeney KM, Yurist-Doutsch S, Arrieta MC, Finlay BB. Effects of antibiotics on human microbiota and subsequent disease. Annu Rev Microbiol. 2014;68:217-35. doi: 10.1146/annurev-micro-091313-103456. Epub 2014 Jun 2.

  PMID: 24995874 BACKGROUND

• Nevins ML, Camelo M, Schupbach P, Kim SW, Kim DM, Nevins M. Human clinical and histologic evaluation of laser-assisted new attachment procedure. Int J Periodontics Restorative Dent. 2012 Oct;32(5):497-507.

  PMID: 22754897 BACKGROUND

• Luke AM, Mathew S, Altawash MM, Madan BM. Lasers: A Review With Their Applications in Oral Medicine. J Lasers Med Sci. 2019 Fall;10(4):324-329. doi: 10.15171/jlms.2019.52. Epub 2019 Oct 1.

  PMID: 31875126 BACKGROUND

• Jha A, Gupta V, Adinarayan R. LANAP, Periodontics and Beyond: A Review. J Lasers Med Sci. 2018 Spring;9(2):76-81. doi: 10.15171/jlms.2018.16. Epub 2018 Mar 20.

  PMID: 30026890 BACKGROUND

• Bechir ES. The Clinical and Microbiological Effects of LANAP Compared to Scaling and Root Planing Alone in the Management of Periodontal Conditions. Diagnostics (Basel). 2023 Jul 22;13(14):2450. doi: 10.3390/diagnostics13142450.

  PMID: 37510194 BACKGROUND

• Cobb CM. Clinical significance of non-surgical periodontal therapy: an evidence-based perspective of scaling and root planing. J Clin Periodontol. 2002 May;29 Suppl 2:6-16.

  PMID: 12010523 BACKGROUND

• Wassall RR, Preshaw PM. Clinical and technical considerations in the analysis of gingival crevicular fluid. Periodontol 2000. 2016 Feb;70(1):65-79. doi: 10.1111/prd.12109.

  PMID: 26662483 BACKGROUND

• Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.

  PMID: 32383274 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Periodontal Pocket

Interventions

Lasers; Photochemotherapy

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Sarhang S Gul

  University of Sulaimani

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 6, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)