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Completed

NCT Number: NCT01215201

Diode Laser Study for Periodontal Maintenance Patients

This study tries to determine whether the additional use of laser with "cleaning" (known as scaling and root planning) will result in the reduction of inflammation, reduction of bleeding upon examination and reduction of pocket depth in patients who are being maintained on a regular basis but have pocket depths that are ≥5mm with bleeding. When a pocket is bleeding, it is inflamed. It is usually "cleaned" with periodontal instruments (root-planed) to establish health. Some research also advocates using laser therapy to treat a bleeding pocket. Laser therapy is presently being performed in some dental offices and dental colleges. This research is trying to see if the additional laser therapy is beneficial.

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Key information

Conditions

Periodontal Diseases Jaw Diseases Mouth Diseases Periapical Diseases Periapical Granuloma Periapical Periodontitis Periodontitis Periodontitis, Apical, Chronic Nonsuppurative Stomatognathic Diseases Suppuration of Gingival Crevice

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center, College of Dentistry

Lincoln, Nebraska, 68583, United States

About this study

The purpose of this study is to determine whether the adjunctive use of diode laser with scaling and root planing is more effective than scaling and root planing alone in clinically reducing periodontal pocket depth (PD), reducing bleeding on probing (BOP) and gaining of clinical attachment level (CAL). It also assesses whether diode laser with scaling and root planing will have an effect on cytokines and inflammatory biomarkers compared to root planing alone.

Any adult who is currently a routine periodontal maintenance patient and has one or more ≥ 5mm pockets with BOP will be invited to participate in the study. If they choose to participate, they will sign an informed consent. Crevicular fluid samples from each test site and another non-involved site in the mouth will be collected utilizing the standard protocol and frozen for later analyses of the presence of certain inflammatory biomarkers (IL-1β). Baseline data (i.e., PD, CAL, BOP, suppuration, supragingival plaque, subgingival restorative margins, smoking status) will be collected. The involved teeth will then be randomly treated with scaling and root-planing with hand instruments and diode laser (test) or scaling and root-planing with hand instruments alone. The patient will return 3 months later for follow-up data collection. He/she will then receive his/her regular 3 month maintenance therapy.

The changes between baseline and 3 months for the clinical parameters and gingival crevicular fluids' inflammatory biomarkers will be compared between test and control experimental sites.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any adult periodontal maintenance patient having had chronic periodontitis with last active therapy at least 3 months prior and with 1 or more sites/subject with ≥5mm probing depth that have bleeding on probing and/or suppuration. They have signed an informed consent form to participate in the study.

Exclusion criteria

  • Subjects who are un-controlled diabetics, use NSAIDS regularly for chronic disease/pain, used antibiotics for the last 3 months, require antibiotic coverage for therapy, are pregnant and below age 30.

Treatment and study plan

Scaling and Root Planing

Procedure

Use periodontal hand instruments (curettes) to remove plaque, bacteria, and deposits on the root's surfaces.

Diode Laser + Scaling and Root Planing

Procedure

First: Periodontal hand instruments (curettes) were used to remove plaque, bacteria, and deposits on the root's surfaces (within a periodontal pocket) Then: Biolase 940 nm Ezlase diode laser was used to sterilize a periodontal pocket. Power: 0.80 Watts Wavelength: 940 nm Energy level: 0.80 Joules/second Mode of beam delivery: continuous

Primary outcomes

  1. Periodontal clinical parameters

    Time frame: 3 months

    Reduction in Probing Depth, Gaining of clinical attachment level, Reduction of Bleeding upon Probing, Reduction of Plaque accumulation, reduction of IL-1B inflammatory marker.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

Adjunctive Non-Surgical Therapy of Inflamed Periodontal Pockets Using Diode Lasers During Maintenance Therapy

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 6, 2010
Registry last updated
Sep 15, 2023

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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