Diode Laser Study for Periodontal Maintenance Patients
Periodontal Maintenance Patients With Chronic Periodontitis With ≥5mm Probing Depth That Have Bleeding on Probing and/or Suppuration.
Device: Diode Laser
|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|
- 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.
|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)|
Scaling and root planing
Device: Diode Laser
Diode Laser is used in addition to the standard Scaling and root planing procedure.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01215201
|United States, Nebraska|
|University of Nebraska Medical Center, College of Dentistry|
|Lincoln, Nebraska, United States, 68583|
|Principal Investigator:||Naomi-Trang Nguyen, D.D.S.||University of Nebraska Medical Center, College of Dentistry|