NCT04964167

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 7, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

June 28, 2021

Last Update Submit

September 9, 2023

Conditions

PeriodontitisPeriodontal Inflammation

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (3)

Group I (Standard Root Planning)

PLACEBO COMPARATOR
Combination Product: Plant extract

Group II (Standard Root Planning + Photodynamic Therapy)

ACTIVE COMPARATOR
Combination Product: Plant extract

Group III (Standard Root Planning + Aloe Vera)

EXPERIMENTAL
Combination Product: Plant extract

Interventions

Plant extractCOMBINATION_PRODUCT

Natural plant extract

Also known as: Aloe Vera
Group I (Standard Root Planning)Group II (Standard Root Planning + Photodynamic Therapy)Group III (Standard Root Planning + Aloe Vera)

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Liaquat College of Medicine and Dentistry

Karachi, Pakistan

Location

Riyadh Elm University

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Plant Extracts

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 15, 2021

Study Start

September 7, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)PA(1)