search
Back to results

Diode Laser Therapy As An Adjunct To Scaling And Root Planing

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasonic Scaling and root planing
980 nm diode laser irradiation
Sponsored by
KLE Society's Institute of Dental Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 40 systemically healthy subjects diagnosed with generalized moderate CP in the age group of 30 to 50 years.
  • Minimum of 20 teeth having atleast two non-adjacent sites per quadrant with probing pocket depth of ≥ 5mm and clinical attachment loss of 3- 4 mm

Exclusion Criteria:

  • Patients who had undergone periodontal therapy 6 months prior to the commencement of the study.
  • Subjects on antibiotics or immunosuppressants.
  • Chronic smokers, alcoholics, smokeless tobacco users.
  • Subjects with acute illnesses/acute intraoral lesions.
  • Pregnant women
  • Subjects who had undergone extensive restorative dental treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Ultrasonic Scaling, Root planing

    980 nm diode Laser irradiation

    Arm Description

    Ultrasonic Scaling and Root planing at day 0 and at 1 week.

    Irradiation of periodontal pockets with with 980 nm diode Laser after scaling and root planing at day 0 and after 1 week.

    Outcomes

    Primary Outcome Measures

    Change in levels of P.gingivalis
    Microbial profile was assessed using PCR at baseline, 4-6 weeks and 12-14 weeks post treatment in both the study groups.

    Secondary Outcome Measures

    Change in gingival index
    Gingival index by Loe and Silness was assessed at baseline, 4-6 weeks and 12-14 weeks post treatment in both the groups
    Change in plaque index
    Plaque index by Silness and Loe was assessed at baseline, 4-6 weeks and 12-14 weeks
    Change in probing pocket depth
    Probing pocket depth was assessed at baseline, 4-6 weeks and 12-14 weeks
    Change in clinical attachment level
    Clinical attachment level was assessed at baseline, 4-6 weeks and 12-14 weeks

    Full Information

    First Posted
    January 7, 2017
    Last Updated
    January 19, 2017
    Sponsor
    KLE Society's Institute of Dental Sciences
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03028727
    Brief Title
    Diode Laser Therapy As An Adjunct To Scaling And Root Planing
    Official Title
    Diode Laser Therapy As An Adjunct To Non-Surgical Management Of Chronic Periodontitis - A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    KLE Society's Institute of Dental Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Laser therapy has been proposed as a novel treatment option in controlling subgingival microorganisms. This randomized controlled clinical trial evaluates the effect of 980nm diode laser as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis (CP).
    Detailed Description
    Conventional mechanical debridement can achieve a temporary decrease in the subgingival levels of Pg along with other pathogens. However, mechanical therapy alone may fail to eliminate pathogenic bacterial niches in inaccessible areas like deep pockets, root concavities, furcation areas etc. In search of more efficient and less traumatic techniques to improve periodontal healing, researchers proposed the use of lasers in periodontal therapy. The adjunctive use of lasers with conventional tools may facilitate treatment and have the potential to improve healing. The diode laser is highly absorbed in hemoglobin and other pigments and is excellent for use in soft tissue surgical procedures.Laser application in improving clinical outcome in periodontal therapy, needs to be further investigated with well designed clinical trials. The investigators attempted to evaluate the efficacy of diode laser as an adjunct to SRP in the management of CP by evaluating clinical parameters coupled with quantitative estimation of P.gingivalis using Real-time Polymerase chain reaction (RT-PCR) assay.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasonic Scaling, Root planing
    Arm Type
    Active Comparator
    Arm Description
    Ultrasonic Scaling and Root planing at day 0 and at 1 week.
    Arm Title
    980 nm diode Laser irradiation
    Arm Type
    Experimental
    Arm Description
    Irradiation of periodontal pockets with with 980 nm diode Laser after scaling and root planing at day 0 and after 1 week.
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasonic Scaling and root planing
    Intervention Description
    Procedure of scaling and root planing at day 0 and at 1 week
    Intervention Type
    Procedure
    Intervention Name(s)
    980 nm diode laser irradiation
    Intervention Description
    Procedure of scaling and root planing and application of 980 nm diode laser at day 0 and at 1 week
    Primary Outcome Measure Information:
    Title
    Change in levels of P.gingivalis
    Description
    Microbial profile was assessed using PCR at baseline, 4-6 weeks and 12-14 weeks post treatment in both the study groups.
    Time Frame
    14 weeks
    Secondary Outcome Measure Information:
    Title
    Change in gingival index
    Description
    Gingival index by Loe and Silness was assessed at baseline, 4-6 weeks and 12-14 weeks post treatment in both the groups
    Time Frame
    14 weeks
    Title
    Change in plaque index
    Description
    Plaque index by Silness and Loe was assessed at baseline, 4-6 weeks and 12-14 weeks
    Time Frame
    14 weeks
    Title
    Change in probing pocket depth
    Description
    Probing pocket depth was assessed at baseline, 4-6 weeks and 12-14 weeks
    Time Frame
    14 weeks
    Title
    Change in clinical attachment level
    Description
    Clinical attachment level was assessed at baseline, 4-6 weeks and 12-14 weeks
    Time Frame
    14 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 40 systemically healthy subjects diagnosed with generalized moderate CP in the age group of 30 to 50 years. Minimum of 20 teeth having atleast two non-adjacent sites per quadrant with probing pocket depth of ≥ 5mm and clinical attachment loss of 3- 4 mm Exclusion Criteria: Patients who had undergone periodontal therapy 6 months prior to the commencement of the study. Subjects on antibiotics or immunosuppressants. Chronic smokers, alcoholics, smokeless tobacco users. Subjects with acute illnesses/acute intraoral lesions. Pregnant women Subjects who had undergone extensive restorative dental treatment.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Diode Laser Therapy As An Adjunct To Scaling And Root Planing

    We'll reach out to this number within 24 hrs