Clinical trial

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

Name
FIRP/2021/94
Description
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.
Trial arms
Trial start
2021-09-07
Estimated PCD
2022-02-28
Trial end
2022-02-28
Status
Completed
Phase
Early phase I
Treatment
Plant extract
Natural plant extract
Arms:
Group I (Standard Root Planning), Group II (Standard Root Planning + Photodynamic Therapy), Group III (Standard Root Planning + Aloe Vera)
Other names:
Aloe Vera
Size
150
Primary endpoint
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
IL-6 concentration in pg/ml
6 months
IL-8 concentration in pg/ml
6 months
TNF-α levels in pg/ml
6 months
Periodontal pocket depth in mm
6 months
Clinical attachment loss in mm
6 months
Eligibility criteria
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 150, 'type': 'ACTUAL'}}
Updated at
2023-09-13

1 organization

1 product

2 indications

Indication
periodontitis
Indication
Periodontitis