PeriodontitisNCT06731777
Oral Gel Containing PHTALOX® as an Adjuvant in the Treatment of Periodontal Disease
A study testing Scaling and root planing plus 0.12% chlorhexidine oral gel and Scaling and root planing plus PHTALOX® oral gel in people with Periodontitis, run by Universidade Federal de Alfenas at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Scaling and root planing plus 0.12% chlorhexidine oral gel and Scaling and root planing plus PHTALOX® oral gel
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jan 2023to 5 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Undergoing orthodontic treatment.
- Individuals with blood dyscrasias.
- Alcoholism.
- Use of illicit drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Periodontitis
- Being tested
- Scaling and root planing plus PHTALOX® oral gel vehicle, Scaling and root planing plus 0.12% chlorhexidine oral gel, Scaling and root planing plus PHTALOX® oral gel
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planing plus PHTALOX® oral gel vehicleProcedure or surgery
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 gelProcedure or surgery
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 gelProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Vehicle Group | Sham comparator | Toothbrushing with dental gel and local application of the PHTALOX® oral gel vehicle Receives: 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. Receives: 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 Receives: Procedure: Scaling and root planing plus PHTALOX® oral gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the baseline (day 0) to post-treatment (day 45)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: From the baseline (day 0) to post-treatment (day 45)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start5 Jan 2023
- Primary completion5 Oct 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Alfenas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Franchin, Universidade Federal de Alfenas
- Investigators
- Marcelo Franchin, PhD, Principal investigator, Universidade Federal de Alfenas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731777
- Sponsor's protocol ID
- 39624820.6.0000.5142
- Status last verified
- May 2026
- First submitted
- 9 Dec 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Gel Containing PHTALOX® as an Adjuvant in the Treatment of Periodontal Disease: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06731777
- Acronym / sponsor ID
- 39624820.6.0000.5142
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidade Federal de AlfenasUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 5 Oct 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vehicle Group | Sham comparator | Procedure: Scaling and root planing plus PHTALOX® oral gel vehicleToothbrushing with dental gel and local application of the PHTALOX® oral gel vehicle |
| Chlorhexidine Group | Active comparator | Procedure: Scaling and root planing plus 0.12% chlorhexidine oral gelToothbrushing with dental gel and local application of 0.12% chlorhexidine oral gel. |
| PHTALOX® Group | Experimental | Procedure: Scaling and root planing plus PHTALOX® oral gelToothbrushing with dental gel and local application of 1% PHTALOX® oral gel |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaling and root planing plus PHTALOX® oral gel vehicleRoot 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. | Procedure or surgery | Vehicle Group |
| Scaling and root planing plus 0.12% chlorhexidine oral gelRoot 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. | Procedure or surgery | Chlorhexidine Group |
| Scaling and root planing plus PHTALOX® oral gelRoot 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. | Procedure or surgery | PHTALOX® Group |
Primary outcome
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.
4 secondary outcomes
Number of sites with improved clinical attachment level
Time frame: From the baseline (day 0) to post-treatment (day 45)
Percentage of sites with bleeding on probing
Time frame: From the baseline (day 0) to post-treatment (day 45)
Percentage of sites with biofilm
Time frame: From the baseline (day 0) to post-treatment (day 45)
Number of teeth with dental mobility (by grade)
Time frame: From the baseline (day 0) to post-treatment (day 45)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo Franchin, PhD principal investigator
Universidade Federal de Alfenas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing plus 0.12% chlorhexidine oral gel and Scaling and root planing plus PHTALOX® oral gel in people with Periodontitis, run by Universidade Federal de Alfenas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sites with reduced probing depth (time frame: From the baseline (day 0) to post-treatment (day 45)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.