NCT06731777

Oral Gel Containing PHTALOX® as an Adjuvant in the Treatment of Periodontal Disease

Active, enrolled NA Last updated 16 December 2024

What this trial tests

NA trial testing Scaling and root planing plus PHTALOX® oral gel vehicle in Periodontitis in 45 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

5 January 2023

Primary endpoint
5 February 2025

5 June 2025

Quick facts

Lead sponsor	Universidade Federal de Alfenas
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	45
Start date	5 January 2023
Primary completion	5 February 2025
Estimated completion	5 June 2025
Sites	1 location across Brazil

Drugs / interventions tested

• Scaling and root planing plus PHTALOX® oral gel vehicle
• Scaling and root planing plus 0.12% chlorhexidine oral gel
• Scaling and root planing plus PHTALOX® oral gel

Conditions studied

• Periodontitis — all drugs for Periodontitis →

Sponsor

Universidade Federal de Alfenas — full company profile →

Who can join

Adults 18 to 50, any sex, with Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Periodontitis, a chronic inflammatory condition of the periodontal tissues, impacts not only the patient's oral and systemic health but also has significant social and economic implications. While mechanical treatment effectively removes calculus and dental biofilm, it may fail to eliminate pathogenic bacteria in soft tissues and in areas inaccessible to periodontal instruments, such as furcation regions, root concavities, interproximal areas, and deep periodontal pockets. Consequently, adjuvant therapies with antimicrobial and anti-inflammatory potential represent a valuable strategy for periodontitis treatment. In this context, an oral gel containing a phthalocyanine derivative, known for its antimicrobial and anti-inflammatory properties, offers a promising enhancement to conventional periodontal treatment. This randomized controlled clinical trial aimed to evaluate the effect of the topical application of an oral gel formulation containing iron tetracarboxyphthalocyanine (PHTALOX®) in the non-surgical periodontal treatment. Patients with periodontitis underwent a standard periodontal treatment protocol (scaling and root planing), followed by adjuvant therapy according to the assigned groups: Vehicle Group: Toothbrushing with dental gel and local application of the PHTALOX® oral gel vehicle. Chlorhexidine Group: Toothbrushing with dental gel and local application of 0.12% chlorhexidine oral gel. PHTALOX® Group: Toothbrushing with dental gel and local application of 1% PHTALOX® oral gel. Clinical evaluations (plaque index, probing depth, bleeding on probing, clinical attachment level, and mobility test) were performed at baseline (day 0) and post-treatment (day 45).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.