Diode Laser Study for Periodontal Maintenance Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Periodontitis, Apical, Chronic Nonsuppurative; Suppuration of Gingival Crevice
• Intervention / Treatment: Procedure: Scaling and Root Planing; Procedure: Diode Laser + Scaling and Root Planing

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68583
      • University of Nebraska Medical Center, College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Scaling and Root Planing Alone; Control group	Procedure: Scaling and Root Planing; Use periodontal hand instruments (curettes) to remove plaque, bacteria, and deposits on the root's surfaces.
Experimental: Diode Laser plus Scaling and Root Planing; Diode Laser is used in addition to Scaling and root planing procedure.	Procedure: Diode Laser + Scaling and Root Planing; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Naomi-Trang Nguyen, DDS, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: October 4, 2010
• First Submitted That Met QC Criteria: October 4, 2010
• First Posted (Estimated): October 6, 2010

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Periodontal maintenance; ≥5mm probing depth; bleeding on probing and/or suppuration
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Stomatognathic Diseases; Mouth Diseases; Jaw Diseases; Periapical Diseases; Periodontitis; Periapical Periodontitis; Periodontal Diseases; Suppuration; Periapical Granuloma
• Other Study ID Numbers: 0452-09-EP