NCT05119283

Clinical Study of a Formulation Containing Phtalox® in Periodontal Disease

Completed NA Last updated 6 December 2024

What this trial tests

NA trial testing Scraping and straightening of the crown and root and rinsing with mouthwashes in Periodontal Diseases in 30 participants. Completed in 30 August 2024.

Timeline

7 March 2022

Primary endpoint
31 March 2024

30 August 2024

Quick facts

Lead sponsor	Universidade Federal de Alfenas
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	7 March 2022
Primary completion	31 March 2024
Estimated completion	30 August 2024
Sites	1 location across Brazil

Drugs / interventions tested

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

Conditions studied

• Periodontal Diseases — all drugs for Periodontal Diseases →
• Periodontitis — all drugs for Periodontitis →
• Bone Loss — all drugs for Bone Loss →

Sponsor

Universidade Federal de Alfenas — full company profile →

Who can join

Adults 18 to 50, any sex, with Periodontal Diseases or Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.