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

Oral Gel Containing PHTALOX® as an Adjuvant in the Treatment of Periodontal Disease: A Randomized Controlled Clinical Trial

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).

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Scaling and root planing plus PHTALOX® oral gel vehicle; Procedure: Scaling and root planing plus 0.12% chlorhexidine oral gel; Procedure: Scaling and root planing plus PHTALOX® oral gel

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Alfenas, Minas Gerais, Brazil, 37130-001
      • Universidade Federal de Alfenas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Vehicle Group; Toothbrushing with dental gel and local application of the PHTALOX® oral gel vehicle	Procedure: 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.
Active Comparator: Chlorhexidine Group; Toothbrushing with dental gel and local application of 0.12% chlorhexidine oral gel.	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.
Experimental: PHTALOX® Group; Toothbrushing with dental gel and local application of 1% PHTALOX® oral gel	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of sites with improved clinical attachment level	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.	From the baseline (day 0) to post-treatment (day 45)
Percentage of sites with bleeding on probing	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.	From the baseline (day 0) to post-treatment (day 45)
Percentage of sites with biofilm	The presence or absence of biofilm on the tooth surface, assessed at for sites per tooth (mesio, buccal, disto and lingual).	From the baseline (day 0) to post-treatment (day 45)
Number of teeth with dental mobility (by grade)	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)	From the baseline (day 0) to post-treatment (day 45)

Collaborators and Investigators

• Sponsor: Universidade Federal de Alfenas
• Investigators: Principal Investigator: Marcelo Franchin, PhD, Universidade Federal de Alfenas

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): October 5, 2024
• Study Completion (Actual): December 5, 2024

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Digestive System and Oral Physiological Phenomena; Dentistry; Dental Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Subgingival Curettage; Preventive Dentistry; Root Planing; Tooth Exfoliation
• Other Study ID Numbers: 39624820.6.0000.5142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No