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Completed

NCT Number: NCT06731777

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

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).

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Alfenas

Alfenas, Minas Gerais, 37130-001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Number of sites with reduced probing depth

    Time frame: 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 outcomes

  1. Number of sites with improved clinical attachment level

    Time frame: 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.

  2. Percentage of sites with bleeding on probing

    Time frame: 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.

  3. Percentage of sites with biofilm

    Time frame: 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).

  4. Number of teeth with dental mobility (by grade)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Universidade Federal de Alfenas

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 12, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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