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

NCT03716154 | Completed

• 1 other identifier: JUSTShbool1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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)

  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 Outcomes (1)

• GI index score ,PI index score

  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

Study Arms (2)

SRP and diode laser

EXPERIMENTAL

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

Radiation: Diode laser

SRP alone

NO INTERVENTION

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

Interventions

Diode laser RADIATION

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

SRP and diode laser

Eligibility Criteria

• Age: 28 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

ROLA

Irbid, Jordan

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• rola A alhabashneh, prof

  Jordan University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: split mouth

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 23, 2018
• Study Start: April 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: April 30, 2018
• Last Updated: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)