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

NAActive, not recruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

January 5, 2023

Primary Completion Date

February 5, 2025

Study Completion Date

June 5, 2025

Conditions
Periodontitis
Interventions
PROCEDURE

Scaling and root planing plus PHTALOX® oral gel vehicle

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.

PROCEDURE

Scaling and root planing plus 0.12% chlorhexidine oral gel

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.

PROCEDURE

Scaling and root planing plus PHTALOX® oral gel

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.

Trial Locations (1)

37130-001

Universidade Federal de Alfenas, Alfenas

All Listed Sponsors
lead

Universidade Federal de Alfenas

OTHER