Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients

NCT03453476 | Completed

• 1 other identifier: NUSingapore
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Photodynamic therapy; Interleukin 1-beta; Tumour necrosis factor - alpha; Interleukin-6; Interleukin-8; Matrix metalloproteinase-8

Outcome Measures

Primary Outcomes (9)

• Changes from baseline probing depth at 3rd month and 6th month

  Clinical probing depth in mm

  3 months and 6 months

• Changes from baseline clinical attachment level at 3rd month and 6th month

  Clinical attachment level in mm

  3 months and 6 months

• Changes from baseline gingival recession level at 3rd month and 6th month

  Gingival recession level in mm

  3 months and 6 months

• Changes from baseline bleeding score at 3rd month and 6th month

  Bleeding score in percentage

  3 months and 6 months

• Changes from baseline Interleukin-1 level at 3rd month and 6th month

  Interleukin-1 level in gingival crevicular fluid

  3 months and 6 months

• Changes from baseline Interleukin-6 level at 3rd month and 6th month

  Interlekin-6 level in gingival crevicular fluid

  3 months and 6 months

• Changes from baseline Interleukin-8 level at 3rd month and 6th month

  Interleukin-8 level in gingival crevicular fluid

  3 months and 6 months

• Changes from baseline Tumour necrosis factor-alpha level at 3rd month and 6th month

  Tumour necrosis factor-alpha level in gingival crevicular fluid

  3 months and 6 months

• Changes from baseline Matrix metalloproteinase-8 level at 3rd month and 6th month

  Matrix metalloproteinase-8 level in gingival crevicular fluid

  3 months and 6 months

Study Arms (2)

SRP and Fotosan 630

EXPERIMENTAL

Scaling and root planing, photodynamic therapy using Fotosan 630

Device: SRP and Fotosan 630

Control

NO INTERVENTION

Scaling and root planing only

Interventions

SRP and Fotosan 630 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.

Also known as: Fotosan 630, CMS Dental, Copenhagen, Denmark

SRP and Fotosan 630

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National University of Singapore: lead

MeSH Terms

Conditions

Chronic Periodontitis; Periodontal Pocket; Periodontitis; Periodontal Attachment Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periodontal Atrophy

Study Officials

• Lum Peng Lim

  Faculty of Dentistry, National University of Singapore

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Allocation of test and control quadrants were done randomly by asking each study participant to choose either numbers "1" or "2". Number "1" defined quadrants 1 and 3 as the test quadrants while number "2" referred to quadrants 2 and 4 as the test quadrants. The remaining quadrants served as the control quadrants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontic Resident, Faculty of Dentistry

Model Details: Split-mouth design

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: March 5, 2018
• Study Start: January 1, 2012
• Primary Completion: March 31, 2013
• Study Completion: June 30, 2013
• Last Updated: March 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share