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Diode Laser Study for Periodontal Maintenance Patients

Primary Purpose

Periodontal Diseases, Periodontitis, Apical, Chronic Nonsuppurative, Suppuration of Gingival Crevice

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scaling and Root Planing
Diode Laser + Scaling and Root Planing
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periodontal Diseases focused on measuring Periodontal maintenance, ≥5mm probing depth, bleeding on probing and/or suppuration

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Nebraska Medical Center, College of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Scaling and Root Planing Alone

Diode Laser plus Scaling and Root Planing

Arm Description

Control group

Diode Laser is used in addition to Scaling and root planing procedure.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 4, 2010
Last Updated
September 13, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT01215201
Brief Title
Diode Laser Study for Periodontal Maintenance Patients
Official Title
Adjunctive Non-Surgical Therapy of Inflamed Periodontal Pockets Using Diode Lasers During Maintenance Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2010 (Actual)
Primary Completion Date
June 1, 2011 (Actual)
Study Completion Date
July 1, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Periodontitis, Apical, Chronic Nonsuppurative, Suppuration of Gingival Crevice
Keywords
Periodontal maintenance, ≥5mm probing depth, bleeding on probing and/or suppuration

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scaling and Root Planing Alone
Arm Type
Other
Arm Description
Control group
Arm Title
Diode Laser plus Scaling and Root Planing
Arm Type
Experimental
Arm Description
Diode Laser is used in addition to Scaling and root planing procedure.
Intervention Type
Procedure
Intervention Name(s)
Scaling and Root Planing
Intervention Description
Use periodontal hand instruments (curettes) to remove plaque, bacteria, and deposits on the root's surfaces.
Intervention Type
Procedure
Intervention Name(s)
Diode Laser + Scaling and Root Planing
Intervention Description
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 Outcome Measure Information:
Title
Periodontal clinical parameters
Description
Reduction in Probing Depth, Gaining of clinical attachment level, Reduction of Bleeding upon Probing, Reduction of Plaque accumulation, reduction of IL-1B inflammatory marker.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi-Trang Nguyen, DDS
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center, College of Dentistry
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68583
Country
United States

12. IPD Sharing Statement

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Diode Laser Study for Periodontal Maintenance Patients

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