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

Not Applicable

Active, not recruiting

• Conditions: Periodontitis

• Registration Number: NCT06731777
• Lead Sponsor: Universidade Federal de Alfenas

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-05
• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-02-05
• Study Completion: 2025-06-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of sites with reduced probing depth	From the baseline (day 0) to post-treatment (day 45)	Probing depth is determined as the distance from the gingival margin to the base of the pocket, measured at six sites per tooth: mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual.

Secondary Outcome Measures

Name	Time	Method
Number of sites with improved clinical attachment level	From the baseline (day 0) to post-treatment (day 45)	The clinical attachment level is determined as the distance from the cementoenamel junction to the base of the pocket, measured at six sites per tooth: mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual.
Percentage of sites with bleeding on probing	From the baseline (day 0) to post-treatment (day 45)	Bleeding on probing is evaluated 30 seconds after probing and recorded as present or absent at six sites per tooth: mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual.
Percentage of sites with biofilm	From the baseline (day 0) to post-treatment (day 45)	The presence or absence of biofilm on the tooth surface, assessed at for sites per tooth (mesio, buccal, disto and lingual).
Number of teeth with dental mobility (by grade)	From the baseline (day 0) to post-treatment (day 45)	Dental mobility is determined as the degree of movement of a tooth within its socket, assessed and recorded according to the following grades: Grade I (slight, up to 1 mm horizontal movement), Grade II (moderate, more than 1 mm horizontal movement), and Grade III (severe, includes vertical movement)

Trial Locations

Locations (1)

Universidade Federal de Alfenas; 🇧🇷 Alfenas, Minas Gerais, Brazil