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

NCT ID: NCT06731777

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2025-06-05

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).

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vehicle Group

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

Group Type: SHAM_COMPARATOR

Scaling and root planing plus PHTALOX® oral gel vehicle

Intervention Type: PROCEDURE

Root scaling and planing (RAR) will be performed following the full-mouth disinfection (FMD) protocol. After anesthesia using the regional block technique \[2% lidocaine solution with 1:100,000 epinephrine (Nova DFL)\], RAR will be conducted by an experienced professional using an ultrasonic scaler and periodontal curettes (Millenium Curettes, Golgran, São Paulo, Brazil). The time spent per quadrant will be approximately one hour. Polishing will then be performed using a rubber cup and prophylactic paste (Odahcam, Dentsply Sirona, USA). The oral gel (PHTALOX® oral gel vehicle) should be applied to all free dental surfaces using a plastic applicator with cotton tips. The contact between the gel and the tooth surface must last for 5 minutes. After this time, the patient should spit out the excess gel without rinsing the mouth. This process should be performed after the last brushing of the day for a period of 45 days.

Chlorhexidine Group

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

Group Type: ACTIVE_COMPARATOR

Scaling and root planing plus 0.12% chlorhexidine oral gel

Intervention Type: PROCEDURE

Root scaling and planing (RAR) will be performed following the full-mouth disinfection (FMD) protocol. After anesthesia using the regional block technique \[2% lidocaine solution with 1:100,000 epinephrine (Nova DFL)\], RAR will be conducted by an experienced professional using an ultrasonic scaler and periodontal curettes (Millenium Curettes, Golgran, São Paulo, Brazil). The time spent per quadrant will be approximately one hour. Polishing will then be performed using a rubber cup and prophylactic paste (Odahcam, Dentsply Sirona, USA). The oral gel (0.12% chlorhexidine oral gel) should be applied to all free dental surfaces using a plastic applicator with cotton tips. The contact between the gel and the tooth surface must last for 5 minutes. After this time, the patient should spit out the excess gel without rinsing the mouth. This process should be performed after the last brushing of the day for a period of 45 days.

PHTALOX® Group

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

Group Type: EXPERIMENTAL

Scaling and root planing plus PHTALOX® oral gel

Intervention Type: PROCEDURE

Root scaling and planing (RAR) will be performed following the full-mouth disinfection (FMD) protocol. After anesthesia using the regional block technique \[2% lidocaine solution with 1:100,000 epinephrine (Nova DFL)\], RAR will be conducted by an experienced professional using an ultrasonic scaler and periodontal curettes (Millenium Curettes, Golgran, São Paulo, Brazil). The time spent per quadrant will be approximately one hour. Polishing will then be performed using a rubber cup and prophylactic paste (Odahcam, Dentsply Sirona, USA). The oral gel (PHTALOX®) should be applied to all free dental surfaces using a plastic applicator with cotton tips. The contact between the gel and the tooth surface must last for 5 minutes. After this time, the patient should spit out the excess gel without rinsing the mouth. This process should be performed after the last brushing of the day for a period of 45 days.

Interventions

Scaling and root planing plus PHTALOX® oral gel vehicle

Root scaling and planing (RAR) will be performed following the full-mouth disinfection (FMD) protocol. After anesthesia using the regional block technique \[2% lidocaine solution with 1:100,000 epinephrine (Nova DFL)\], RAR will be conducted by an experienced professional using an ultrasonic scaler and periodontal curettes (Millenium Curettes, Golgran, São Paulo, Brazil). The time spent per quadrant will be approximately one hour. Polishing will then be performed using a rubber cup and prophylactic paste (Odahcam, Dentsply Sirona, USA). The oral gel (PHTALOX® oral gel vehicle) should be applied to all free dental surfaces using a plastic applicator with cotton tips. The contact between the gel and the tooth surface must last for 5 minutes. After this time, the patient should spit out the excess gel without rinsing the mouth. This process should be performed after the last brushing of the day for a period of 45 days.

Intervention Type: PROCEDURE

Scaling and root planing plus 0.12% chlorhexidine oral gel

Root scaling and planing (RAR) will be performed following the full-mouth disinfection (FMD) protocol. After anesthesia using the regional block technique \[2% lidocaine solution with 1:100,000 epinephrine (Nova DFL)\], RAR will be conducted by an experienced professional using an ultrasonic scaler and periodontal curettes (Millenium Curettes, Golgran, São Paulo, Brazil). The time spent per quadrant will be approximately one hour. Polishing will then be performed using a rubber cup and prophylactic paste (Odahcam, Dentsply Sirona, USA). The oral gel (0.12% chlorhexidine oral gel) should be applied to all free dental surfaces using a plastic applicator with cotton tips. The contact between the gel and the tooth surface must last for 5 minutes. After this time, the patient should spit out the excess gel without rinsing the mouth. This process should be performed after the last brushing of the day for a period of 45 days.

Intervention Type: PROCEDURE

Scaling and root planing plus PHTALOX® oral gel

Root scaling and planing (RAR) will be performed following the full-mouth disinfection (FMD) protocol. After anesthesia using the regional block technique \[2% lidocaine solution with 1:100,000 epinephrine (Nova DFL)\], RAR will be conducted by an experienced professional using an ultrasonic scaler and periodontal curettes (Millenium Curettes, Golgran, São Paulo, Brazil). The time spent per quadrant will be approximately one hour. Polishing will then be performed using a rubber cup and prophylactic paste (Odahcam, Dentsply Sirona, USA). The oral gel (PHTALOX®) should be applied to all free dental surfaces using a plastic applicator with cotton tips. The contact between the gel and the tooth surface must last for 5 minutes. After this time, the patient should spit out the excess gel without rinsing the mouth. This process should be performed after the last brushing of the day for a period of 45 days.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Alfenas

OTHER

Sponsor Role: lead

Responsible Party

Marcelo Franchin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcelo Franchin, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Alfenas

Locations

Universidade Federal de Alfenas

Alfenas, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

39624820.6.0000.5142

Identifier Type: -

Identifier Source: org_study_id