Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients

NCT ID: NCT03453476

Last Updated: 2018-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2013-06-30

Brief Summary

Systemically healthy periodontitis patients were recruited in this single-blind, split-mouth, randomized controlled clinical trial. After SRP, PDT was applied at probing depth (PD) ≥ 4 mm at test quadrant. At baseline, 3rd month and 6th month, clinical parameters and cytokine pattern in gingival crevicular fluids (GCFs) were analysed.

Detailed Description

Periodontal parameters and cytokine IL-1β, IL-6, IL-8, TNF-α, MMP-8 levels were analysed.

Conditions

Periodontitis, Adult; Periodontal Pocket; Periodontitis; Periodontal Attachment Loss

Study Design

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

Study Groups

SRP and Fotosan 630

Scaling and root planing, photodynamic therapy using Fotosan 630

Group Type: EXPERIMENTAL

SRP and Fotosan 630

Intervention Type: DEVICE

After isolating the test quadrants with cotton roll, toluidine blue was applied into the deep pockets (PD ≥ 4mm) at the test quadrants for 10 seconds, followed by inserting a perio tip (15 or 21 mm depending on the depth of the pocket) that connected to a LED emitting device, and light was emitted for 20 seconds. Toluidine blue in the deep pocket was removed by injecting normal saline into the pocket.

Control

Scaling and root planing only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SRP and Fotosan 630

After isolating the test quadrants with cotton roll, toluidine blue was applied into the deep pockets (PD ≥ 4mm) at the test quadrants for 10 seconds, followed by inserting a perio tip (15 or 21 mm depending on the depth of the pocket) that connected to a LED emitting device, and light was emitted for 20 seconds. Toluidine blue in the deep pocket was removed by injecting normal saline into the pocket.

Intervention Type: DEVICE

Other Intervention Names

Fotosan 630, CMS Dental, Copenhagen, Denmark

Eligibility Criteria

Inclusion Criteria

• Adults who were medically fit or have medical condition that did not alter the outcome of periodontal treatment.
• Females who were not pregnant or nursing.
• Controlled diabetes mellitus with HbA1c < 7.5 mmol/L.
• Not on any antibiotics or steroids 3 months prior to periodontal treatment.
• Diagnosed to have either localized or generalized chronic or aggressive periodontitis (Armitage, 1999) with all 4 quadrants having at least 2 sites with probing depth ≥ 4 mm.
• Consented to follow the non-surgical periodontal treatment (scaling and root planing) with PDT throughout the period of study, i.e. approximately 6 months.

Exclusion Criteria

• Allergic to photosensitizer or dye
• Pregnant lady and nursing mothers
• Uncontrolled diabetes

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University of Singapore

OTHER

Sponsor Role: lead

Responsible Party

Foo Lean Heong

Periodontic Resident, Faculty of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lum Peng Lim

Role: STUDY_DIRECTOR

Faculty of Dentistry, National University of Singapore

Other Identifiers

NUSingapore

Identifier Type: -

Identifier Source: org_study_id