Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis

Overview

For proving the potential of tropical medicaments on clinical parameters of periodontitis, a comprehensive assessment is required between therapeutic medicaments. The main aim of the study was to clinically evaluate and compare the efficacy of indocyanine green mediated photodynamic therapy (PDT) and aleo vera (AV) extract when used as an adjunct therapy to scaling and root planning (SRP) for treatment of chronic periodontitis. One hundred and fifty patients included in this study were randomly distributed in three treatment groups Group I (SRP), Group II (SRP+PDT) and Group III (SRP+AV). Four clinical parameters plaque index (PI), bleeding on probing (BoP), periodontal (PD) pocket depth and clinical attachment level (CAL) were evaluated at three time points baseline, 3rd and 6th month respectively. Additionally the amount of three inflammatory cytokines IL-6, IL-8 and TNF- α in gingival crevicular fluid (GCF) was identified using enzyme linked immune-sorbent assay (ELISA) technique.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 28, 2022

Interventions

  • Combination Product: Plant extract
    • Natural plant extract

Arms, Groups and Cohorts

  • Placebo Comparator: Group I (Standard Root Planning)
  • Active Comparator: Group II (Standard Root Planning + Photodynamic Therapy)
  • Experimental: Group III (Standard Root Planning + Aloe Vera)

Clinical Trial Outcome Measures

Primary Measures

  • Clinically Evaluating the Effects of Topical Indocyanine-green Mediated Photosensitizer VS Aloe vera Gel: Adjunct therapy to Scaling and Root Planing in Patients with Chronic Periodontitis
    • Time Frame: 9 months
    • Adjunct treatment regimens PDT and AV extract significantly helped in plummeting inflammation of PD tissue
  • IL-6 concentration in pg/ml
    • Time Frame: 6 months
    • Identify the concentration of IL-6 in the gingival crevicular fluid
  • IL-8 concentration in pg/ml
    • Time Frame: 6 months
    • Identify the concentration of IL-8 in the gingival crevicular fluid
  • TNF-α levels in pg/ml
    • Time Frame: 6 months
    • Identify the concentration of TNF-α in the gingival crevicular fluid
  • Periodontal pocket depth in mm
    • Time Frame: 6 months
    • Periodontal pocket depth
  • Clinical attachment loss in mm
    • Time Frame: 6 months
    • Periodontal attachment loss

Participating in This Clinical Trial

Inclusion Criteria

  • age of ≥ 30 years; – ≥ 20 natural teeth; and – chronic-periodontitis (≥ 3 mm of CAL and PD pocket depth respectively on at least 30% of dental sites). Exclusion Criteria:

  • chronic systemic diseases; – PD therapy during last 6 months; – habitual use of chewable and non-chewable tobacco (smoking); – alcohol consumers; or – use of particular medications during last three months (steroidal and non-steroidal drugs/ anti-biotic/ anti-depressants)

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Riyadh Elm University
  • Collaborator
    • Salah Abdalkreem Almohana
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zeeshan Qamar, Assistant Professor – Riyadh Elm University

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