Clinical Effectiveness of Diode Laser as an Adjunct in the Treatment of Periodontitis

NCT ID: NCT03716154

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2018-04-30

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.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SRP and diode laser

In a split mouth design either left or right sites randomly treated by SRP and diode laser as an adjunct

Group Type: EXPERIMENTAL

Diode laser

Intervention Type: RADIATION

Diode laser 810nm, 2W, 20sec, 20 HZ

SRP alone

The other sites in the other side will be treated by SRP alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Diode laser

Diode laser 810nm, 2W, 20sec, 20 HZ

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jordan University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

rola A alhabashneh, prof

Role: STUDY_DIRECTOR

Jordan University of Science and Technology

Locations

ROLA

Irbid, , Jordan

Countries

Jordan

Other Identifiers

JUSTShbool1

Identifier Type: -

Identifier Source: org_study_id