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

Riyadh Elm University

Status and phase: Completed; Phase 4

Conditions: Periodontitis; Periodontal Inflammation

Treatments: Combination Product: Plant extract

Study type: Interventional

Funder types: Other

Identifiers

NCT04964167

FIRP/2021/94

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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150 participants in 3 patient groups, including a placebo group

Group I (Standard Root Planning)

Placebo Comparator group

Treatment:

Combination Product: Plant extract

Group II (Standard Root Planning + Photodynamic Therapy)

Active Comparator group

Treatment:

Combination Product: Plant extract

Group III (Standard Root Planning + Aloe Vera)

Experimental group

Treatment:

Combination Product: Plant extract