Periodontal DiseasesNCT05119283
Clinical Study of a Formulation Containing Phtalox® in Periodontal Disease
A study testing Scraping and straightening of the crown and root and rinsing with mouthwashes in people with Periodontal Diseases and Periodontitis, run by Universidade Federal de Alfenas at 1 site in Brazil.
Trial summary
Periodontitis is a chronic and destructive inflammation that leads to the loss of tissue supporting the teeth, the periodontium, and possibly tooth loss and edentulism. Its etiology is related to an overload on the host's defense mechanisms, consequent to the accumulation of plaque or suppression of the immune system. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Periodontal Diseases, Periodontitis, Bone Loss
- What is being tested?
- Scraping and straightening of the crown and root and rinsing with mouthwashes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Mar 2022to 30 Aug 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
- Individuals of both sexes
- Individuals without a history of systemic complications for more than 6 months
- Individuals with no recent history of drug use
- Systemically healthy individuals
- Individuals with periodontal disease
Who cannot join
- Individuals who do not wish to complete the treatment protocol
- Individuals with healthy periodontium
- pregnant women
- Infants
- Individuals who use drugs
- Individuals with systemic alterations
Show all 9Show fewer
- Individuals who used antibiotics in the last 3 months
- Individuals with systemic diseases that require antibiotic prophylaxis before periodontal therapy
- Immunosuppressed individuals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of a Formulation Containing Phtalox® for the Prevention and Control of Periodontal Disease
Periodontitis is a chronic and destructive inflammation that leads to the loss of tissue supporting the teeth, the periodontium, and possibly tooth loss and edentulism. Its etiology is related to an overload on the host's defense mechanisms, consequent to the accumulation of plaque or suppression of the immune system. Standard treatment for periodontitis includes scaling and root planing (RAR) and possible association with therapeutic adjuvants such as systemic and local antimicrobials. However, the use of these drugs supporting the treatment of periodontitis, has shown adverse effects such as loss of taste, soft tissue burn, pain, xerostomia, supragingival calculus formation and change in staining of teeth, restorations, prostheses and tongue. Other effects not as common as mucosal ulcerations, desquamative lesions, urticaria, dyspnea, anaphylactic shock and swellings reversible effects in the parotid glands and lips have also been observed and reported in the literature. Thus, there is a need for new adjuvant therapies, which cause less effects side effects and that are more effective in the treatment of periodontitis and in the maintenance of oral health.
The commercial product PHTALOX® is a phthalocyanine dental mouthwash that has a spectrum of action based on the formation of reactive oxygen that acts by inhibiting odor-causing substances, on microorganisms and on the mechanisms of coagulation and healing. Your supporting action in periodontal treatment may have promising potential. Thus, the purpose of this study clinical trial will be testing a formulation containing PHTALOX® for disease prevention and control Periodontal (PD). 30 patients will be recruited who will undergo scaling and straightening coronaroradicular (RAR), and after basic periodontal treatment will be randomly divided into 3 groups according to the supporting treatment: G1 - patients who will receive mouthwashes with physiological solution; G2 - patients who will receive 0.12% chlorhexidine mouthwash; G3 - patients who will be treated with PHTALOX®. Clinical reassessments of patients will be carried out before the treatments, and at 15, 30 and 60 days after the performance of the RAR and beginning of the respective mouthwash. After data collection, intra and intergroup analyzes will be performed comparing the therapeutic results for the periodontal condition through the "Bioestat" program.
Read the detailed description
PATIENT SELECTION
The research project will be submitted to the Ethics Committee for Research with Human Beings, at the Federal University of Alfenas (UNIFAL-MG), following the resolution of the National Health Council 466/2012.
Statistical planning was performed using the formula n = 1 + [2 * 10.51 * (0.2 / 0.172) ²], obtaining a number of approximately 30 patients, with a study power of 90%. This study will be clinical, double blind, involving patients aged between 18 and 50 years, who will be seen at the Periodontics Clinic of the Faculty of Dentistry, UNIFAL-MG and diagnosed with periodontitis. Secondary data will not be used for the study. After diagnosis, patients will read and sign the Informed Consent Form.
Patients will answer a questionnaire about their socioeconomic conditions, and soon after undergoing the examination for bleeding, probing, clinical attachment level, probing depth and plaque index for initial clinical evaluation. Basic periodontal treatment will be carried out with the same operator (blind to the treatments performed), with complete removal of plaque and calculi, prophylaxis with pumice and prophylactic paste and oral hygiene instructions. After basic periodontal treatment, patients will be randomly divided based on a draw with closed, opaque and non-translucent envelopes, into 3 groups according to the supporting treatments: G1 - patients who will receive mouthwashes with saline solution; G2 - patients who will be rinsed with 0.12% chlorhexidine and G3 - patients who will be treated with PHTALOX®. Each group will consist of the same number of patients, that is, 10. Patients will receive 140 mL of the substances, to be used for 7 days, twice a day.
Clinical reassessments of patients will be made before the treatments, and at 15, 30 and 60 after the performance of the RAR and beginning of the respective mouthwashes.
INSTRUCTIONS TO PATIENTS
Patients will be instructed on how they will use therapeutic adjuvants, according to the product to be used. In the act of orientation, the patient will use the adjunct for further explanation and standardization.
Treated patients will be instructed to use the product twice a day for 7 days, one in the morning and one in the evening, 30 minutes after brushing and flossing. The mouthwash should be carried out for 30 seconds with 10 mL of the solution corresponding to the group. All products must be completely expelled after rinsing. No product can be diluted in water and, after its use, the patient cannot eat or drink any liquid for at least 30 minutes. The patient will be advised that any signs of irritation, pain or other adverse effects that may appear are reported to the research group for evaluation.
As for oral hygiene habits, the patient should brush their teeth at least 3 times a day and floss at least once a day. The mean value of the frequency of oral hygiene habits will be collected at the end of the treatment, as well as information regarding gender, age, socioeconomic level, education level and number of teeth, for further analysis.
In addition, patients will be evaluated through the Community Periodontal Index, O' Leary Index and Bleeding Index on Probing.
STATISTICAL ANALYSIS
After collecting the primary data, intra and intergroup analyzes will be performed comparing socioeconomic results, periodontal condition, and treatments in isolation and their interrelationships through the "Bioestat" program.
- Conditions
- Periodontal Diseases, Periodontitis, Bone Loss
- Being tested
- Scraping and straightening of the crown and root and rinsing with mouthwashes
- Keywords
- Oral Antiseptic, Mouth Rinse, Periodontal treatment
- Medical subject headings
- Periodontal Diseases, Periodontitis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scraping and straightening of the crown and root and rinsing with mouthwashesOther
Patients will answer a questionnaire about their socioeconomic conditions, and soon after undergoing the examination for bleeding, probing, clinical attachment level, probing depth and plaque index for initial clinical evaluation. Basic periodontal treatment will be carried out with the same operator (blind to the treatments performed), with complete removal of plaque and calculi, prophylaxis with pumice and prophylactic paste and oral hygiene instructions. After basic periodontal treatment, patients will be randomly divided based on a draw with closed, opaque and non-translucent envelopes, into 3 groups according to the supporting treatments: G1 - patients who will receive mouthwashes with saline solution; G2 - patients who will be rinsed with 0.12% chlorhexidine and G3 - patients who will be treated with PHTALOX®.
| Study group | Role | What they receive |
|---|---|---|
| Phtalox | Experimental | Patients will undergo scaling and coronal-radicular smoothing and rinses with PHTALOX mouthwashes. Receives: Other: Scraping and straightening of the crown and root and rinsing with mouthwashes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in COMMUNITY PERIODONTAL INDEX (CPI)
Will be obtained through periodontal probing in millimeters (mm) in six points of the index teeth. It allows evaluating the periodontal condition regarding health, bleeding and presence of calculus or pocket. The objective is to evaluate the improvement of periodontal conditions of patients.
Measured: At Baseline ,15, 30 and 60 days after the performance of the RAR
Change in O' LEARY INDEX
will be obtained by the percentage (%) of bacterial plaque on the faces of all teeth present in the oral cavity, dividing the number of surfaces containing plaque by the total number of surfaces evaluated. The objective is to evaluate the improvement of periodontal conditions of patients.
Measured: At 15, 30 and 60 days after the performance of the RAR
Change in PROBING BLEEDING INDEX (ISS)
Will be obtained by the percentage (%) of bleeding represented by the number of bleeding tooth surfaces, divided by the number of tooth surfaces examined. The objective is to evaluate the improvement of periodontal conditions of patients.
Measured: At 15, 30 and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start7 Mar 2022
- Primary completion31 Mar 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Thirty patients will be recruited who will undergo scaling and coronal-root planing (RAR), and after basic periodontal treatment will be randomly divided into 3 groups according to the supporting treatment: G1 - patients who will receive mouthwashes with saline solution; G2 - patients who will receive 0.12% chlorhexidine mouthwash; G3 - patients who will be treated with PHTALOX®.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Alfenas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leandro Fernandes, Doctor, Principal investigator, UNIFAL-MG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119283
- Sponsor's protocol ID
- Phtalox in Periodontal Disease
- Status last verified
- Dec 2024
- First submitted
- 20 Oct 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At first, the data will not be shared with other researchers. This will take place at the time of publication of the research results.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of a Formulation Containing Phtalox® for the Prevention and Control of Periodontal Disease
- ClinicalTrials.gov ID
- NCT05119283
- Acronym / sponsor ID
- Phtalox in Periodontal Disease
- Conditions
- Periodontal Diseases, Periodontitis, Bone Loss
- Keywords
- Oral Antiseptic, Mouth Rinse, Periodontal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Federal de AlfenasUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 15 Nov 2021 (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 is a chronic and destructive inflammation that leads to the loss of tissue supporting the teeth, the periodontium, and possibly tooth loss and edentulism. Its etiology is related to an overload on the host's defense mechanisms, consequent to the accumulation of plaque or suppression of the immune system. Standard treatment for periodontitis includes scaling and root planing (RAR) and possible association with therapeutic adjuvants such as systemic and local antimicrobials. However, the use of these drugs supporting the treatment of periodontitis, has shown adverse effects such as loss of taste, soft tissue burn, pain, xerostomia, supragingival calculus formation and change in staining of teeth, restorations, prostheses and tongue. Other effects not as common as mucosal ulcerations, desquamative lesions, urticaria, dyspnea, anaphylactic shock and swellings reversible effects in the parotid glands and lips have also been observed and reported in the literature. Thus, there is a need for new adjuvant therapies, which cause less effects side effects and that are more effective in the treatment of periodontitis and in the maintenance of oral health.
The commercial product PHTALOX® is a phthalocyanine dental mouthwash that has a spectrum of action based on the formation of reactive oxygen that acts by inhibiting odor-causing substances, on microorganisms and on the mechanisms of coagulation and healing. Your supporting action in periodontal treatment may have promising potential. Thus, the purpose of this study clinical trial will be testing a formulation containing PHTALOX® for disease prevention and control Periodontal (PD). 30 patients will be recruited who will undergo scaling and straightening coronaroradicular (RAR), and after basic periodontal treatment will be randomly divided into 3 groups according to the supporting treatment: G1 - patients who will receive mouthwashes with physiological solution; G2 - patients who will receive 0.12% chlorhexidine mouthwash; G3 - patients who will be treated with PHTALOX®. Clinical reassessments of patients will be carried out before the treatments, and at 15, 30 and 60 days after the performance of the RAR and beginning of the respective mouthwash. After data collection, intra and intergroup analyzes will be performed comparing the therapeutic results for the periodontal condition through the "Bioestat" program.
Detailed description
PATIENT SELECTION
The research project will be submitted to the Ethics Committee for Research with Human Beings, at the Federal University of Alfenas (UNIFAL-MG), following the resolution of the National Health Council 466/2012.
Statistical planning was performed using the formula n = 1 + [2 * 10.51 * (0.2 / 0.172) ²], obtaining a number of approximately 30 patients, with a study power of 90%. This study will be clinical, double blind, involving patients aged between 18 and 50 years, who will be seen at the Periodontics Clinic of the Faculty of Dentistry, UNIFAL-MG and diagnosed with periodontitis. Secondary data will not be used for the study. After diagnosis, patients will read and sign the Informed Consent Form.
Patients will answer a questionnaire about their socioeconomic conditions, and soon after undergoing the examination for bleeding, probing, clinical attachment level, probing depth and plaque index for initial clinical evaluation. Basic periodontal treatment will be carried out with the same operator (blind to the treatments performed), with complete removal of plaque and calculi, prophylaxis with pumice and prophylactic paste and oral hygiene instructions. After basic periodontal treatment, patients will be randomly divided based on a draw with closed, opaque and non-translucent envelopes, into 3 groups according to the supporting treatments: G1 - patients who will receive mouthwashes with saline solution; G2 - patients who will be rinsed with 0.12% chlorhexidine and G3 - patients who will be treated with PHTALOX®. Each group will consist of the same number of patients, that is, 10. Patients will receive 140 mL of the substances, to be used for 7 days, twice a day.
Clinical reassessments of patients will be made before the treatments, and at 15, 30 and 60 after the performance of the RAR and beginning of the respective mouthwashes.
INSTRUCTIONS TO PATIENTS
Patients will be instructed on how they will use therapeutic adjuvants, according to the product to be used. In the act of orientation, the patient will use the adjunct for further explanation and standardization.
Treated patients will be instructed to use the product twice a day for 7 days, one in the morning and one in the evening, 30 minutes after brushing and flossing. The mouthwash should be carried out for 30 seconds with 10 mL of the solution corresponding to the group. All products must be completely expelled after rinsing. No product can be diluted in water and, after its use, the patient cannot eat or drink any liquid for at least 30 minutes. The patient will be advised that any signs of irritation, pain or other adverse effects that may appear are reported to the research group for evaluation.
As for oral hygiene habits, the patient should brush their teeth at least 3 times a day and floss at least once a day. The mean value of the frequency of oral hygiene habits will be collected at the end of the treatment, as well as information regarding gender, age, socioeconomic level, education level and number of teeth, for further analysis.
In addition, patients will be evaluated through the Community Periodontal Index, O' Leary Index and Bleeding Index on Probing.
STATISTICAL ANALYSIS
After collecting the primary data, intra and intergroup analyzes will be performed comparing socioeconomic results, periodontal condition, and treatments in isolation and their interrelationships through the "Bioestat" program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Thirty patients will be recruited who will undergo scaling and coronal-root planing (RAR), and after basic periodontal treatment will be randomly divided into 3 groups according to the supporting treatment: G1 - patients who will receive mouthwashes with saline solution; G2 - patients who will receive 0.12% chlorhexidine mouthwash; G3 - patients who will be treated with PHTALOX®.
| Arm | Type | Receives |
|---|---|---|
| Phtalox | Experimental | Other: Scraping and straightening of the crown and root and rinsing with mouthwashesPatients will undergo scaling and coronal-radicular smoothing and rinses with PHTALOX mouthwashes. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals of both sexes
- Individuals without a history of systemic complications for more than 6 months
- Individuals with no recent history of drug use
- Systemically healthy individuals
- Individuals with periodontal disease
Key exclusion criteria (9 listed)
- Individuals who do not wish to complete the treatment protocol
- Individuals with healthy periodontium
- pregnant women
- Infants
- Individuals who use drugs
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 |
|---|---|---|
| Scraping and straightening of the crown and root and rinsing with mouthwashesPatients will answer a questionnaire about their socioeconomic conditions, and soon after undergoing the examination for bleeding, probing, clinical attachment level, probing depth and plaque index for initial clinical evaluation. Basic periodontal treatment will be carried out with the same operator (blind to the treatments performed), with complete removal of plaque and calculi, prophylaxis with pumice and prophylactic paste and oral hygiene instructions. After basic periodontal treatment, patients will be randomly divided based on a draw with closed, opaque and non-translucent envelopes, into 3 groups according to the supporting treatments: G1 - patients who will receive mouthwashes with saline solution; G2 - patients who will be rinsed with 0.12% chlorhexidine and G3 - patients who will be treated with PHTALOX®. | Other | Phtalox |
Primary outcome
Change in COMMUNITY PERIODONTAL INDEX (CPI)
Time frame: At Baseline ,15, 30 and 60 days after the performance of the RAR
Will be obtained through periodontal probing in millimeters (mm) in six points of the index teeth. It allows evaluating the periodontal condition regarding health, bleeding and presence of calculus or pocket. The objective is to evaluate the improvement of periodontal conditions of patients.
Change in O' LEARY INDEX
Time frame: At 15, 30 and 60 days after the performance of the RAR
will be obtained by the percentage (%) of bacterial plaque on the faces of all teeth present in the oral cavity, dividing the number of surfaces containing plaque by the total number of surfaces evaluated. The objective is to evaluate the improvement of periodontal conditions of patients.
Change in PROBING BLEEDING INDEX (ISS)
Time frame: At 15, 30 and 60 days
Will be obtained by the percentage (%) of bleeding represented by the number of bleeding tooth surfaces, divided by the number of tooth surfaces examined. The objective is to evaluate the improvement of periodontal conditions of patients.
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 6 Dec 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. At first, the data will not be shared with other researchers. This will take place at the time of publication of the research results.
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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.
Leandro Fernandes, Doctor principal investigator
UNIFAL-MG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scraping and straightening of the crown and root and rinsing with mouthwashes in people with Periodontal Diseases and 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 5 inclusion and 9 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 6 Dec 2024. 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. 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?
Change in COMMUNITY PERIODONTAL INDEX (CPI) (time frame: At Baseline ,15, 30 and 60 days after the performance of the RAR). The study lists 3 primary outcomes in all. 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 6 Dec 2024.