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

Phase 4

Completed

• Conditions: Periodontal Inflammation; Periodontitis
• Interventions: Combination Product: Plant extract

• Registration Number: NCT04964167
• Lead Sponsor: Riyadh Elm University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-15
• Study Start: 2021-09-07
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-09
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group I (Standard Root Planning)	Plant extract	-
Group III (Standard Root Planning + Aloe Vera)	Plant extract	-
Group II (Standard Root Planning + Photodynamic Therapy)	Plant extract	-

Primary Outcome Measures

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

Trial Locations

Locations (2)

Riyadh Elm University; 🇸🇦 Riyadh, Saudi Arabia

Liaquat College of Medicine and Dentistry; 🇵🇰 Karachi, Pakistan