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PeriodontitisNCT06719674

Diode Laser as an Adjunct to Professional Mechanical Plaque Removal

A study testing Professional mechanical plaque removal and Laser and Professional mechanical plaque removal in people with Periodontitis and Pocket, Periodontal, run by University of Sulaimani at 1 site in Iraq.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Periodontitis, Pocket, Periodontal
What is being tested?
Professional mechanical plaque removal and Laser and Professional mechanical plaque removal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteIraq
Study dates
1 Jan 2025to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Iraq1 site
  • College of Dentistry, University of Sulaimani

    Sulaymaniyah, 46001

Other trials in Iraq

About this study

Official title: Impact of Diode Laser as an Adjunct to Professional Mechanical Plaque Removal (PMPR) in Patients With Periodontitis: A Randomized Clinical Trial

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.

Read the detailed description

Periodontitis is an inflammatory disease caused by dental biofilm that provokes a chronic immune-inflammatory response that eventually causes the gradual loss of the periodontal tissues supporting the teeth. The evaluation of the disease is determined by clinical attachment loss (CAL), probing pocket depth (PPD), bleeding on probing (BOP), and the assessment of alveolar bone radiographically. Periodontal disease is a well-established disease that certainly impacts the general well-being of patients. It is closely linked to poor oral health-related quality of life, particularly in patients with moderate to severe periodontitis.

Moreover, a comprehensive study has demonstrated a direct correlation between the severity of the disease, as indicated by higher staging and grading, and an increased likelihood of tooth loss. The primary goal of periodontal therapy is to prevent or arrest the spread of the periodontal infection. The standard treatment approaches involve non-surgical or surgical periodontal therapy. Mechanical instrumentation (professional mechanical plaque removal - PMPR) is the gold standard in treating periodontal diseases; however, it can be challenging to reach and effectively remove calculus and bacterial deposits in the irregular and furcation areas. Therefore, an adjunctive aid like systemic or local antibiotics is sometimes necessary to be administered. Nevertheless, they have many adverse effects and it is also important to reduce the use of systemic antibiotics given the increases in antimicrobial resistance that occur globally.

Another adjunctive aid such as laser has been introduced to the field of periodontology to achieve bacterial eradication with minimum side effects. The term "laser" is derived from the abbreviation "light amplification by stimulated emission of radiation." A laser is a device that produces a well-aligned light beam that is well concentrated, which can maintain its narrowness across a significant distance and be firmly focused. When targeted towards tissues, many interactions occur. The behavior of laser light, including absorption, reflection, transmission, and scattering, is influenced by the laser's wavelength and the tissue's properties.

The primary objective of adjunctive laser use in periodontal therapy is to eliminate the inflamed and necrotic tissues located within the periodontal sulcus. The use of lasers is a contemporary adjunctive to traditional periodontal therapy for treating periodontitis. The alleged benefits of laser therapy include enhanced accessibility to root surfaces, more reliable control of bleeding, and better patient acceptability as it eliminates the requirement for conventional surgical flaps and sutures.

Being tested
Professional mechanical plaque removal and Laser, Professional mechanical plaque removal
Keywords
Non surgical periodontal therapy, Diode laser, Salivary biomarkers
Medical subject headings
Periodontitis, Periodontal Pocket

What participants receive

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

  • Professional mechanical plaque removal and LaserProcedure or surgery

    Also called EPIC 10S Soft Tissue Diode Laser, Photodynamic therapy

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

  • Professional mechanical plaque removalProcedure or surgery

    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.

Study groups in NCT06719674
Study groupRoleWhat they receive
Professional Mechanical Plaque Removal + LaserExperimentalThe 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.
Receives: Procedure: Professional mechanical plaque removal and Laser
Professional Mechanical Plaque RemovalActive comparatorThe 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.
Receives: Procedure: Professional mechanical plaque removal

What is being measured

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

  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.

    Measured: 3 months

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

    The analysis of salivary biomarkers involves different techniques depending on the biomarker of interest, including Enzyme-Linked Immunosorbent Assay (ELISA): A widely used method for detecting proteins, hormones, and cytokines in saliva.

    Measured: 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 posted6 Dec 2024
  2. Study start1 Jan 2025
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06719674
Sponsor's protocol ID
USulaimani/SGUL
Status last verified
Apr 2026
First submitted
1 Dec 2024
Last updated
4 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data will be available upon reasonable request by the principal investigator.

Publications

  • 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.

    PubMed 29926951
  • 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.

    PubMed 23662085
  • 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.

    PubMed 33484162
  • 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.

    PubMed 25198637
  • 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.

    PubMed 24995874
  • 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.

    PubMed 22754897
  • 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.

    PubMed 31875126
  • 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.

    PubMed 30026890
  • 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.

    PubMed 37510194
  • 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.

    PubMed 12010523
  • 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.

    PubMed 26662483
  • 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.

    PubMed 32383274

Questions about this trial

What is this clinical trial studying?

A study testing Professional mechanical plaque removal and Laser and Professional mechanical plaque removal in people with Periodontitis and Pocket, Periodontal, run by University of Sulaimani at 1 site in Iraq.

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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. 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 Iraq. 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?

This study is still under way. Results are not available in the source record yet.

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?

Reduction in probing pocket depth (mm) (time frame: 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 NCT06719674, which also lists 12 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 4 May 2026.

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