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
About this trial
This is an interventional treatment trial for Chronic Periodontitis
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.
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
NCT ID
NCT03028727
First Posted
January 7, 2017
Last Updated
January 19, 2017
Sponsor
KLE Society's Institute of Dental Sciences
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
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