Clinical trial NCT06731777: Oral Gel Containing PHTALOX® as an Adjuvant in the Treatment of Periodontal Disease
Official title: Oral Gel Containing PHTALOX® as an Adjuvant in the Treatment of Periodontal Disease: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Periodontitis
Lead sponsor: Universidade Federal de Alfenas
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with periodontitis stages II to IV (moderate to severe) grades A-C, with at least two non-adjacent interproximal sites showing probing depth (PD) ≥5 mm, clinical attachment level (CAL) ≥3 mm, and bleeding on probing

Exclusion Criteria:

* Medical conditions requiring antibiotic prophylaxis or that could influence the response to treatment.
* History of periodontal treatment within the last 6 months.
* Use of medications affecting periodontal tissues within the last 3 months (antibiotics, anti-inflammatory drugs, anticonvulsants, immunosuppressants, or calcium channel blockers).
* Smokers or former smokers within the last 12 months.
* Pregnancy.
* Extensive prosthetic rehabilitation.
* Undergoing orthodontic treatment.
* Individuals with blood dyscrasias.
* Alcoholism.
* Use of illicit drugs.

Primary outcomes:
measure: Number of sites with reduced probing depth
timeFrame: From the baseline (day 0) to post-treatment (day 45)
Secondary outcomes:
measure: Number of sites with improved clinical attachment level
timeFrame: From the baseline (day 0) to post-treatment (day 45)
measure: Percentage of sites with bleeding on probing
timeFrame: From the baseline (day 0) to post-treatment (day 45)
measure: Percentage of sites with biofilm
timeFrame: From the baseline (day 0) to post-treatment (day 45)
measure: Number of teeth with dental mobility (by grade)
timeFrame: From the baseline (day 0) to post-treatment (day 45)
Other outcomes:
Locations:
city: Alfenas
country: Brazil
facility: Universidade Federal de Alfenas
state: Minas Gerais
Study officials:
affiliation: Universidade Federal de Alfenas
name: Marcelo Franchin, PhD
role: PRINCIPAL_INVESTIGATOR
References: