Clinical trial NCT03453476: Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients
Official title: Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth design
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes from baseline probing depth at 3rd month and 6th month
timeFrame: 3 months and 6 months
measure: Changes from baseline clinical attachment level at 3rd month and 6th month
timeFrame: 3 months and 6 months
measure: Changes from baseline gingival recession level at 3rd month and 6th month
timeFrame: 3 months and 6 months
measure: Changes from baseline bleeding score at 3rd month and 6th month
timeFrame: 3 months and 6 months
measure: Changes from baseline Interleukin-1 level at 3rd month and 6th month
timeFrame: 3 months and 6 months
measure: Changes from baseline Interleukin-6 level at 3rd month and 6th month
timeFrame: 3 months and 6 months
measure: Changes from baseline Interleukin-8 level at 3rd month and 6th month
timeFrame: 3 months and 6 months
measure: Changes from baseline Tumour necrosis factor-alpha level at 3rd month and 6th month
timeFrame: 3 months and 6 months
measure: Changes from baseline Matrix metalloproteinase-8 level at 3rd month and 6th month
timeFrame: 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Dentistry, National University of Singapore
name: Lum Peng Lim
role: STUDY_DIRECTOR
References: