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Completed

NCT Number: NCT04964167

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

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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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Periodontal Inflammation Stomatognathic Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Liaquat College of Medicine and Dentistry, Karachi, Pakistan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Plant extract

Combination Product

Natural plant extract

Other names: Aloe Vera

Primary outcomes

  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

    Time frame: 9 months

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

  2. IL-6 concentration in pg/ml

    Time frame: 6 months

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

  3. IL-8 concentration in pg/ml

    Time frame: 6 months

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

  4. TNF-α levels in pg/ml

    Time frame: 6 months

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

  5. Periodontal pocket depth in mm

    Time frame: 6 months

    Periodontal pocket depth

  6. Clinical attachment loss in mm

    Time frame: 6 months

    Periodontal attachment loss

Sponsors and collaborators

Lead sponsor

Riyadh Elm University

Other

Collaborators

  • Abdulelah Khalid Alanazi
  • Abdulmohsen Khalid Alanazi
  • Alhanouf Abdulkarem Almohana
  • Salah Abdalkreem Almohana

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 15, 2021
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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