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

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 Overview

• Status: Completed
• Conditions: Periodontitis; Periodontal Inflammation
• Intervention / Treatment: Combination product: Plant extract

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Karachi, Pakistan
    • Liaquat College of Medicine and Dentistry
• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Riyadh Elm University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group I (Standard Root Planning)	Combination product: Plant extract; Natural plant extract; Other Names: Aloe Vera
Active Comparator: Group II (Standard Root Planning + Photodynamic Therapy)	Combination product: Plant extract; Natural plant extract; Other Names: Aloe Vera
Experimental: Group III (Standard Root Planning + Aloe Vera)	Combination product: Plant extract; Natural plant extract; Other Names: Aloe Vera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Adjunct treatment regimens PDT and AV extract significantly helped in plummeting inflammation of PD tissue	9 months
IL-6 concentration in pg/ml	Identify the concentration of IL-6 in the gingival crevicular fluid	6 months
IL-8 concentration in pg/ml	Identify the concentration of IL-8 in the gingival crevicular fluid	6 months
TNF-α levels in pg/ml	Identify the concentration of TNF-α in the gingival crevicular fluid	6 months
Periodontal pocket depth in mm	Periodontal pocket depth	6 months
Clinical attachment loss in mm	Periodontal attachment loss	6 months

Collaborators and Investigators

• Sponsor: Riyadh Elm University
• Collaborators: Salah Abdalkreem Almohana; Abdulmohsen Khalid Alanazi; Abdulelah Khalid Alanazi; Alhanouf Abdulkarem Almohana

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 9, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Chronic Disease; Periodontitis; Inflammation; Chronic Periodontitis
• Other Study ID Numbers: FIRP/2021/94

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No