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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-07

Study Completion Date

2022-02-28

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.

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Detailed Description

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Conditions

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Periodontitis Periodontal Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group I (Standard Root Planning)

Group Type PLACEBO_COMPARATOR

Plant extract

Intervention Type COMBINATION_PRODUCT

Natural plant extract

Group II (Standard Root Planning + Photodynamic Therapy)

Group Type ACTIVE_COMPARATOR

Plant extract

Intervention Type COMBINATION_PRODUCT

Natural plant extract

Group III (Standard Root Planning + Aloe Vera)

Group Type EXPERIMENTAL

Plant extract

Intervention Type COMBINATION_PRODUCT

Natural plant extract

Interventions

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Plant extract

Natural plant extract

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Aloe Vera

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)

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes