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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04964167
• Other study ID #: FIRP/2021/94
• Status: Completed
• Phase: Phase 4
• Start date: September 7, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: September 2023
• Source: Riyadh Elm University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Periodontitis
• Inflammation
• Periodontal Inflammation
• Periodontitis

Intervention

Combination Product:
• Plant extract
Natural plant extract

Locations

Country	Name	City	State
Pakistan	Liaquat College of Medicine and Dentistry	Karachi
Saudi Arabia	Riyadh Elm University	Riyadh

Sponsors (5)

Lead Sponsor	Collaborator
Riyadh Elm University	Abdulelah Khalid Alanazi, Abdulmohsen Khalid Alanazi, Alhanouf Abdulkarem Almohana, Salah Abdalkreem Almohana

Countries where clinical trial is conducted

Pakistan,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	IL-6 concentration in pg/ml	Identify the concentration of IL-6 in the gingival crevicular fluid	6 months
Primary	IL-8 concentration in pg/ml	Identify the concentration of IL-8 in the gingival crevicular fluid	6 months
Primary	TNF-a levels in pg/ml	Identify the concentration of TNF-a in the gingival crevicular fluid	6 months
Primary	Periodontal pocket depth in mm	Periodontal pocket depth	6 months
Primary	Clinical attachment loss in mm	Periodontal attachment loss	6 months