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

NCT06731777 | Active Not Recruiting

• 1 other identifier: 39624820.6.0000.5142
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of sites with reduced probing depth

  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.

  From the baseline (day 0) to post-treatment (day 45)

Secondary Outcomes (4)

• Number of sites with improved clinical attachment level

  From the baseline (day 0) to post-treatment (day 45)

• Percentage of sites with bleeding on probing

  From the baseline (day 0) to post-treatment (day 45)

• Percentage of sites with biofilm

  From the baseline (day 0) to post-treatment (day 45)

• Number of teeth with dental mobility (by grade)

  From the baseline (day 0) to post-treatment (day 45)

Study Arms (3)

Vehicle Group

SHAM COMPARATOR

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

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

Chlorhexidine Group

ACTIVE COMPARATOR

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

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

PHTALOX® Group

EXPERIMENTAL

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

Procedure: Scaling and root planing plus PHTALOX® oral gel

Interventions

Scaling and root planing plus PHTALOX® oral gel vehicle 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.

Vehicle Group

Scaling and root planing plus 0.12% chlorhexidine oral gel 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.

Chlorhexidine Group

Scaling and root planing plus PHTALOX® oral gel 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.

PHTALOX® Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Alfenas: lead

Study Sites (1)

Universidade Federal de Alfenas

Alfenas, Minas Gerais, 37130-001, Brazil

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Marcelo Franchin, PhD

  Universidade Federal de Alfenas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: January 5, 2023
• Primary Completion: February 5, 2025
• Study Completion: June 5, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)