- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03028727
Diode Laser Therapy As An Adjunct To Scaling And Root Planing
Diode Laser Therapy As An Adjunct To Non-Surgical Management Of Chronic Periodontitis - A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ultrasonic Scaling, Root planing
Ultrasonic Scaling and Root planing at day 0 and at 1 week.
|
Procedure of scaling and root planing at day 0 and at 1 week
|
Experimental: 980 nm diode Laser irradiation
Irradiation of periodontal pockets with with 980 nm diode Laser after scaling and root planing at day 0 and after 1 week.
|
Procedure of scaling and root planing at day 0 and at 1 week
Procedure of scaling and root planing and application of 980 nm diode laser at day 0 and at 1 week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in levels of P.gingivalis
Time Frame: 14 weeks
|
Microbial profile was assessed using PCR at baseline, 4-6 weeks and 12-14 weeks post treatment in both the study groups.
|
14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in gingival index
Time Frame: 14 weeks
|
Gingival index by Loe and Silness was assessed at baseline, 4-6 weeks and 12-14 weeks post treatment in both the groups
|
14 weeks
|
Change in plaque index
Time Frame: 14 weeks
|
Plaque index by Silness and Loe was assessed at baseline, 4-6 weeks and 12-14 weeks
|
14 weeks
|
Change in probing pocket depth
Time Frame: 14 weeks
|
Probing pocket depth was assessed at baseline, 4-6 weeks and 12-14 weeks
|
14 weeks
|
Change in clinical attachment level
Time Frame: 14 weeks
|
Clinical attachment level was assessed at baseline, 4-6 weeks and 12-14 weeks
|
14 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KLESocietyIDS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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