Diode Laser as an Adjunct to Professional Mechanical Plaque Removal

NCT ID: NCT06719674

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-12-01

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.

Conditions

Periodontitis; Pocket, Periodontal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Professional Mechanical Plaque Removal + Laser

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.

Group Type: EXPERIMENTAL

Professional mechanical plaque removal and Laser

Intervention Type: PROCEDURE

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

Professional Mechanical Plaque Removal

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.

Group Type: ACTIVE_COMPARATOR

Professional mechanical plaque removal

Intervention Type: 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.

Interventions

Professional mechanical plaque removal and Laser

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

Intervention Type: PROCEDURE

Professional mechanical plaque removal

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.

Intervention Type: PROCEDURE

Other Intervention Names

EPIC 10S Soft Tissue Diode Laser; Photodynamic therapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Dundee

OTHER

Sponsor Role: collaborator

Sulaimany Polytechnic university

OTHER

Sponsor Role: collaborator

University of Sulaimani

OTHER

Sponsor Role: lead

Responsible Party

Sarhang Gul

Asst. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarhang S Gul

Role: PRINCIPAL_INVESTIGATOR

University of Sulaimani

Locations

College of Dentistry, University of Sulaimani

Sulaymaniyah, , Iraq

Site Status: RECRUITING

Countries

Iraq

Central Contacts

Sarhang S. Gul, PhD

Role: CONTACT

sarhang.hama@univsul.edu.iq

7701447723 ext. +964

Ara S Ali

Role: CONTACT

ara.ali@univsul.edu.iq

7701562321 ext. +964

Facility Contacts

Sarhang S Gul, PhD

Role: primary

sarhang.hama@univsul.edu.iq

7701447723 ext. 00964

References

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Other Identifiers

USulaimani/SGUL

Identifier Type: -

Identifier Source: org_study_id