Clinical Effectiveness of Diode Laser as an Adjunct in the Treatment of Periodontitis
Primary Purpose
Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Diode laser
Sponsored by

About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Healthy patients having periodontitis in at least two quadrants each quadrant should have at least 4 sites with PD >4mm.
- Both male and female patients.
- Patient who are ready to cooperate with diode laser treatment.
- Patient who can comply with 3 visits for follow up (three times).
Exclusion Criteria:
- Subjects with systemic diseases that may interfere with wound healing (such as diabetes) or any systemic disease that complicates the treatment.
- Pregnant women and breast feeding.
- Smokers, alcohol or drug dependent.
- Patients who received any form of periodontal treatment within the last 6 months.
- Patients who are currently taking or were on antibiotic treatment within the last 6 months.
- Presence of faulty restoration at teeth involved in the disease.
- Teeth indicated for extraction at sites that will be part of the study.
- Patient under 18 years of age.
Sites / Locations
- ROLA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SRP and diode laser
SRP alone
Arm Description
In a split mouth design either left or right sites randomly treated by SRP and diode laser as an adjunct
The other sites in the other side will be treated by SRP alone
Outcomes
Primary Outcome Measures
Probing depth (PD) in millimeter (mm), clinical attachment loss (CAL) in millimeter (mm)
PD its the distance from gingival margin to the base of the pocket in millimeter (mm) CAL the recession is added to the PD in millimeter (mm)
Secondary Outcome Measures
Full Information
NCT ID
NCT03716154
First Posted
October 8, 2018
Last Updated
October 20, 2018
Sponsor
Jordan University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT03716154
Brief Title
Clinical Effectiveness of Diode Laser as an Adjunct in the Treatment of Periodontitis
Official Title
Clinical Effectiveness of Diode Laser as an Adjunct in the Treatment of Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jordan University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
a randomized controlled single-blinded study. the hypothesis of this clinical trial is that disjunctive use of diode laser improve the clinical parameters of periodontists , and there are significant difference between the conventional treatment and diode laser as an adjunct
Detailed Description
A total of 240 sites with deep pocket in 30 systemically healthy patients with chronic periodontitis, from subjects attending Jordan University of Science and Technology (JUST) Postgraduate Dental Clinic (PDC), the age range were (28-55) year, between Apr 2017 and Oct 2017. Those patients were enrolled in a randomized controlled single-blinded study. For each patient, full medical and dental history and periodontal examination were recorded. Clinical parameters such as pocket depth (PD), clinical attachment loss (CAL), gingival index (GI) and plaque index (PI) were evaluated at the baseline. All Patients underwent initial periodontal therapy; SRP which was performed using a sonic device and hand instruments and the sites were divided randomly into two groups SRP alone and SRP with adjunctive diode 810 nm laser in the contralateral sites in the same jaw. The Clinical parameters have been re-evaluated at 1, 3 and 6 months to test the effectiveness of (810 nm, 2 W, pulsed mode, for 20 sec) in treatment of CP. Diode laser therapy was applied to periodontal pockets in the same day of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
split mouth
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SRP and diode laser
Arm Type
Experimental
Arm Description
In a split mouth design either left or right sites randomly treated by SRP and diode laser as an adjunct
Arm Title
SRP alone
Arm Type
No Intervention
Arm Description
The other sites in the other side will be treated by SRP alone
Intervention Type
Radiation
Intervention Name(s)
Diode laser
Intervention Description
Diode laser 810nm, 2W, 20sec, 20 HZ
Primary Outcome Measure Information:
Title
Probing depth (PD) in millimeter (mm), clinical attachment loss (CAL) in millimeter (mm)
Description
PD its the distance from gingival margin to the base of the pocket in millimeter (mm) CAL the recession is added to the PD in millimeter (mm)
Time Frame
Change from baseline to 1 month in PD and CAL, change from baseline to 3 month in PD and CAL ,change from baseline to 6 month in PD and CAL
Other Pre-specified Outcome Measures:
Title
GI index score ,PI index score
Description
GI index score:
0 = normal gingiva (pink, scalloped margin, pin pointed papilla, thin buccal and lingual margin);
= mild inflammation (slight changes in color, slight edema, no bleeding on probing);
= moderate inflammation (redness, edema, bleeding on probing)
= severe inflammation (marked redness, edema, ulceration, spontaneous bleeding).
PI index score:
0 = no plaque in the gingival area
= a film of plaque adhering to the gingival margin and adjacent area of the tooth. The plaque may be only recognized by running a probe across the tooth surface.
= moderate accumulation of soft debris within the gingival pocket on the gingival and/or on the tooth surface, which can be seen by naked eye.
= abundance of soft matter within the gingival pocket and /or on the gingival margin and adjacent tooth surface.
Time Frame
Change from baseline in GI and PI at 1 month, change from baseline in GI and PI at 3 month, Change from baseline in GI and PI at 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy patients having periodontitis in at least two quadrants each quadrant should have at least 4 sites with PD >4mm.
Both male and female patients.
Patient who are ready to cooperate with diode laser treatment.
Patient who can comply with 3 visits for follow up (three times).
Exclusion Criteria:
Subjects with systemic diseases that may interfere with wound healing (such as diabetes) or any systemic disease that complicates the treatment.
Pregnant women and breast feeding.
Smokers, alcohol or drug dependent.
Patients who received any form of periodontal treatment within the last 6 months.
Patients who are currently taking or were on antibiotic treatment within the last 6 months.
Presence of faulty restoration at teeth involved in the disease.
Teeth indicated for extraction at sites that will be part of the study.
Patient under 18 years of age.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
rola A alhabashneh, prof
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
ROLA
City
Irbid
Country
Jordan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Effectiveness of Diode Laser as an Adjunct in the Treatment of Periodontitis
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