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

Study Overview
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Brief Summary
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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.

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

Conditions
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Periodontitis, Periodontal Inflammation

Intervention / Treatment
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* Combination Product: Plant extract


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group I (Standard Root Planning)<br> | Combination Product: Plant extract<br>* Natural plant extract<br>* Other names: Aloe Vera;|
| Active Comparator: Group II (Standard Root Planning + Photodynamic Therapy)<br> | Combination Product: Plant extract<br>* Natural plant extract<br>* Other names: Aloe Vera;|
| Experimental: Group III (Standard Root Planning + Aloe Vera)<br> | Combination Product: Plant extract<br>* Natural plant extract<br>* Other names: Aloe Vera;|

What is the study measuring?
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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 |