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Completed

NCT Number: NCT04027686

Clinical Evaluation of Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Gum Disease

The use of lasers to treat various problems in dentistry is growing as it has in medicine. One application is the use of lasers to treat periodontal disease. It has been suggested that the laser may reduce the need for surgical treatment by reducing pockets. The goal of this study is to evaluate the effectiveness of laser treatment for periodontal disease. Laser therapy will be used in addition to traditional non-surgical scaling and root planing (deep cleaning). The information obtained from this study will provide an objective assessment of adjunctive laser therapy compared to conventional periodontal therapy and will attempt to show the benefits, if any, lasers can provide in the treatment of chronic periodontal disease.

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Key information

Conditions

Periodontitis Chronic Generalized Moderate Periodontitis Chronic Generalized Severe

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years old or older (male or female)
  • Healthy without systemic diseases that may adversely effect healing
  • Not pregnant and no current plans to become pregnant
  • No periodontal treatment in the previous 12 months
  • No systemic antibiotic therapy in the previous 6 months
  • At least two quadrants with periodontitis (ideally opposite side same jaw)
  • Each quadrant must have two or more sites with probing pocket depths ≥ 5mm
  • Each quadrant should include interproximal intrabony defect(s)

Exclusion criteria

  • Any systemic disease, medication, or habit known to adversely influence bone metabolism and/or wound healing:
  • Poorly controlled diabetes (HbA1c > 7%)
  • History of bisphosphonate medications
  • History of radiation therapy affecting the proposed treatment site(s)
  • History of immunosuppressive medications (e.g. corticosteroids)
  • History of tobacco use (current or past tobacco use within the past 1 year)
  • Immune compromise caused by disease, treatment or other condition
  • Recent history of periodontal surgery (within the previous 2 years)
  • Recent history of scaling and root planing (within the previous 12 months)
  • Any condition that contraindicates periodontal therapy including surgery

Treatment and study plan

Laser Therapy

Device

Adjunctive application of laser therapy in the periodontal pocket

Non-surgical Scaling and Root Planing

Procedure

Scaling to remove calculus deposits and root planing to smooth root surfaces

Primary outcomes

  1. Probing Pocket Depth

    Time frame: 12 months

    This is a measure from base of pocket to gingival margin.

  2. Sites That Bleed on Probing

    Time frame: 12 months

    Percentage of sites that bleed in response to probing. Bleeding observed within 30 seconds from pocket/sulcus following periodontal probe measurement.

  3. Gingival Recession

    Time frame: 12 months

    Measure of gingival recession following treatment. This is a measure of the gingival margin from the cement-enamel junction.

  4. Clinical Attachment Level

    Time frame: 12 months

    Periodontal clinical attachment level following treatment. This is a calculation (clinical attachment level = probing pocket depth + gingival recession).

Secondary outcomes

  1. Periodontal Microbiome

    Time frame: 12 months

    Assess changes in periodontal microbiome using DNA sequencing

  2. Patient Reported Outcomes: VAS Questionnaire

    Time frame: 12 months

    Measure patient reported pain (0-100), comfort (0-100), sensitivity (0-100) and satisfaction (0-100) using VAS questionnaire, with lower values indicating better outcome for pain and sensitivity and higher values indicating better outcome for comfort and satisfaction.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Biolase Inc

Registry information

Official study title

Clinical Evaluation of WaterLase (iPlus) Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Chronic Periodontitis: A Randomized, Controlled, Split-Mouth Clinical Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 22, 2019
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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