Clinical Study of a Formulation Containing Phtalox® in Periodontal Disease

NCT05119283 | Completed

• 1 other identifier: Phtalox in Periodontal Disease
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Periodontal Diseases; Periodontitis; Bone Loss

Keywords

Oral Antiseptic; Mouth Rinse; Periodontal treatment

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  At 15, 30 and 60 days

Study Arms (1)

Phtalox

EXPERIMENTAL

Patients will undergo scaling and coronal-radicular smoothing and rinses with PHTALOX mouthwashes.

Other: Scraping and straightening of the crown and root and rinsing with mouthwashes

Interventions

Scraping and straightening of the crown and root and rinsing with mouthwashes OTHER

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®.

Phtalox

Eligibility Criteria

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

You may not qualify if:

• 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
• Individuals who used antibiotics in the last 3 months
• Individuals with systemic diseases that require antibiotic prophylaxis before periodontal therapy
• Immunosuppressed individuals
• 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

Sponsors & Collaborators

• Universidade Federal de Alfenas: lead

Study Sites (1)

Unifal-Mg

Alfenas, Minas Gerias, Brazil

Location

Related Links

• Related Info

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Bone Diseases, Metabolic

Interventions

Mouthwashes

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Leandro Fernandes, Doctor

  UNIFAL-MG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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®.

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 15, 2021
• Study Start: March 7, 2022
• Primary Completion: March 31, 2024
• Study Completion: August 30, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)