Clinical trial NCT03716154: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 28
Sex: ALL
Minimum age (years): 28
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split mouth
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Probing depth (PD) in millimeter (mm), clinical attachment loss (CAL) in millimeter (mm)
timeFrame: 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
Secondary outcomes:
Other outcomes:
measure: GI index score ,PI index score
timeFrame: 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
Locations:
city: Irbid
country: Jordan
facility: ROLA
Study officials:
affiliation: Jordan University of Science and Technology
name: rola A alhabashneh, prof
role: STUDY_DIRECTOR
References: