Clinical trial NCT06719674: Diode Laser as an Adjunct to Professional Mechanical Plaque Removal
Official title: Impact of Diode Laser as an Adjunct to Professional Mechanical Plaque Removal (PMPR) in Patients With Periodontitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Pocket, Periodontal
Keywords: Non surgical periodontal therapy
Diode laser
Salivary biomarkers
Lead sponsor: University of Sulaimani
Sponsor class: OTHER
Collaborators: name: University of Dundee
name: Sulaimany Polytechnic university
First posted: 2024-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Reduction in probing pocket depth (mm)
timeFrame: 3 months
Secondary outcomes:
measure: Biomarkers level in pg/ML: (interleukin (IL)-1beta), Matrix metalloproteinases (MMP 8) and (TIMP), RANK.
timeFrame: 3 months
Other outcomes:
Locations:
city: Sulaymaniyah
country: Iraq
facility: College of Dentistry, University of Sulaimani
Study officials:
affiliation: University of Sulaimani
name: Sarhang S Gul
role: PRINCIPAL_INVESTIGATOR
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