Diode Laser Study for Periodontal Maintenance Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of Nebraska.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01215201
First received: October 4, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Periodontal Maintenance Patients With Chronic Periodontitis With ≥5mm Probing Depth That Have Bleeding on Probing and/or Suppuration.
Device: Diode Laser
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Adjunctive Non-Surgical Therapy of Inflamed Periodontal Pockets Using Diode Lasers During Maintenance Therapy

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Periodontal clinical parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Reduction in Probing Depth, Gaining of clinical attachment level, Reduction of Bleeding upon Probing, Reduction of Plaque accumulation, reduction of IL-1B inflammatory marker.


Estimated Enrollment: 110
Study Start Date: May 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Scaling and root planing
Control group
Device: Diode Laser
Diode Laser is used in addition to the standard Scaling and root planing procedure.
Other Name: Diode Laser

Detailed Description:

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, PGE2, MMP-8). 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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215201

Locations
United States, Nebraska
University of Nebraska Medical Center, College of Dentistry
Lincoln, Nebraska, United States, 68583
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Naomi-Trang Nguyen, D.D.S. University of Nebraska Medical Center, College of Dentistry
  More Information

No publications provided

Responsible Party: Naomi-Trang Nguyen, D.D.S., University of Nebraska Medical Center, College of Dentistry
ClinicalTrials.gov Identifier: NCT01215201     History of Changes
Other Study ID Numbers: 452-09-EP
Study First Received: October 4, 2010
Last Updated: October 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Periodontal maintenance
≥5mm probing depth
bleeding on probing and/or suppuration

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Suppuration
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Infection
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014