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

Sponsor
Riyadh Elm University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04964167
Collaborator
Salah Abdalkreem Almohana (Other), Abdulmohsen Khalid Alanazi (Other), Abdulelah Khalid Alanazi (Other), Alhanouf Abdulkarem Almohana (Other)
150
Enrollment
2
Locations
3
Arms
4.8
Anticipated Duration (Months)
75
Patients Per Site
15.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Plant extract
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Sep 7, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Group I (Standard Root Planning)

Combination Product: Plant extract
Natural plant extract
Other Names:
  • Aloe Vera

    		•
    Active Comparator: Group II (Standard Root Planning + Photodynamic Therapy)

    Combination Product: Plant extract
    Natural plant extract
    Other Names:
  • Aloe Vera

    		•
    Experimental: Group III (Standard Root Planning + Aloe Vera)

    Combination Product: Plant extract
    Natural plant extract
    Other Names:
  • Aloe Vera

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

      Adjunct treatment regimens PDT and AV extract significantly helped in plummeting inflammation of PD tissue

    2. IL-6 concentration in pg/ml [6 months]

      Identify the concentration of IL-6 in the gingival crevicular fluid

    3. IL-8 concentration in pg/ml [6 months]

      Identify the concentration of IL-8 in the gingival crevicular fluid

    4. TNF-α levels in pg/ml [6 months]

      Identify the concentration of TNF-α in the gingival crevicular fluid

    5. Periodontal pocket depth in mm [6 months]

      Periodontal pocket depth

    6. Clinical attachment loss in mm [6 months]

      Periodontal attachment loss

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Liaquat College of Medicine and Dentistry Karachi Pakistan
    2 Riyadh Elm University Riyadh Saudi Arabia

    Sponsors and Collaborators

    • Riyadh Elm University
    • Salah Abdalkreem Almohana
    • Abdulmohsen Khalid Alanazi
    • Abdulelah Khalid Alanazi
    • Alhanouf Abdulkarem Almohana

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zeeshan Qamar, Assistant Professor, Riyadh Elm University
    ClinicalTrials.gov Identifier:
    NCT04964167
    Other Study ID Numbers:
    • FIRP/2021/94
    First Posted:
    Jul 15, 2021
    Last Update Posted:
    Sep 22, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Periodontitis
    Chronic Periodontitis
    Inflammation

    Study Results

    No Results Posted as of Sep 22, 2021