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

Primary Purpose

Periodontitis, Periodontal Inflammation

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Plant extract
Sponsored by
Riyadh Elm University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts 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)

Sites / Locations

  • Liaquat College of Medicine and Dentistry
  • Riyadh Elm University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Group I (Standard Root Planning)

Group II (Standard Root Planning + Photodynamic Therapy)

Group III (Standard Root Planning + Aloe Vera)

Arm Description

Outcomes

Primary Outcome Measures

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
IL-6 concentration in pg/ml
Identify the concentration of IL-6 in the gingival crevicular fluid
IL-8 concentration in pg/ml
Identify the concentration of IL-8 in the gingival crevicular fluid
TNF-α levels in pg/ml
Identify the concentration of TNF-α in the gingival crevicular fluid
Periodontal pocket depth in mm
Periodontal pocket depth
Clinical attachment loss in mm
Periodontal attachment loss

Secondary Outcome Measures

Full Information

First Posted
June 28, 2021
Last Updated
September 9, 2023
Sponsor
Riyadh Elm University
Collaborators
Salah Abdalkreem Almohana, Abdulmohsen Khalid Alanazi, Abdulelah Khalid Alanazi, Alhanouf Abdulkarem Almohana
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1. Study Identification

Unique Protocol Identification Number
NCT04964167
Brief Title
Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis
Official Title
Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riyadh Elm University
Collaborators
Salah Abdalkreem Almohana, Abdulmohsen Khalid Alanazi, Abdulelah Khalid Alanazi, Alhanouf Abdulkarem Almohana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Periodontal Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (Standard Root Planning)
Arm Type
Placebo Comparator
Arm Title
Group II (Standard Root Planning + Photodynamic Therapy)
Arm Type
Active Comparator
Arm Title
Group III (Standard Root Planning + Aloe Vera)
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
Plant extract
Other Intervention Name(s)
Aloe Vera
Intervention Description
Natural plant extract
Primary Outcome Measure Information:
Title
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
Description
Adjunct treatment regimens PDT and AV extract significantly helped in plummeting inflammation of PD tissue
Time Frame
9 months
Title
IL-6 concentration in pg/ml
Description
Identify the concentration of IL-6 in the gingival crevicular fluid
Time Frame
6 months
Title
IL-8 concentration in pg/ml
Description
Identify the concentration of IL-8 in the gingival crevicular fluid
Time Frame
6 months
Title
TNF-α levels in pg/ml
Description
Identify the concentration of TNF-α in the gingival crevicular fluid
Time Frame
6 months
Title
Periodontal pocket depth in mm
Description
Periodontal pocket depth
Time Frame
6 months
Title
Clinical attachment loss in mm
Description
Periodontal attachment loss
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Liaquat College of Medicine and Dentistry
City
Karachi
Country
Pakistan
Facility Name
Riyadh Elm University
City
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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