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

Universidade Federal de Alfenas

Status: Active, not recruiting

Conditions: Periodontitis

Treatments: Procedure: Scaling and root planing plus PHTALOX® oral gel vehicle; Procedure: Scaling and root planing plus PHTALOX® oral gel; Procedure: Scaling and root planing plus 0.12% chlorhexidine oral gel

Study type: Interventional

Funder types: Other

Identifiers

NCT06731777

39624820.6.0000.5142

Details and patient eligibility

About

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).

Enrollment: 45 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups

Vehicle Group

Sham Comparator group

Description:

Toothbrushing with dental gel and local application of the PHTALOX® oral gel vehicle

Treatment:

Procedure: Scaling and root planing plus PHTALOX® oral gel vehicle

Chlorhexidine Group

Active Comparator group

Description:

Toothbrushing with dental gel and local application of 0.12% chlorhexidine oral gel.

Treatment:

Procedure: Scaling and root planing plus 0.12% chlorhexidine oral gel

PHTALOX® Group

Experimental group

Description:

Toothbrushing with dental gel and local application of 1% PHTALOX® oral gel

Treatment:

Procedure: Scaling and root planing plus PHTALOX® oral gel