NCT05878353

Influence of Local Doxycycline on the Outcomes of Periodontal Regeneration

Influence of Local Doxycycline on the Inflammatory Status of Intrabony Defects and Clinical Outcomes of Periodontal Regeneration: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In this double-blinded randomized clinical trial, patients presenting periodontal intrabony defects requiring regenerative surgery and showing BoP will be included. Experimental sites at T-0 will be randomly treated with gentle debridement and administration of local DOX (test group) or with debridement alone (control group). After 2 weeks (T-1), defects will be treated by means of minimally invasive surgical technique. 14 days after the surgery (T-2) the EHI will be evaluated by a blinded examiner. Patients will be recalled each 2 months up to 12 months (T-3). At T-0, T-1 and T-3 periodontal examination and radiographic analysis will be done.

Conditions

• Periodontal Diseases

Interventions

Type	Name	Description
PROCEDURE	Decontamination of the pocket with local doxycycline	Gentle debridement will be performed under local anesthesia (mepivacain 2% 1:1000) for a time of 5 minutes by mean of ultrasonic devices by the same experienced clinician. Great attention will be made to avoid marginal and interproximal soft tissue damage. Local doxycycline was administered according to the manufacturer's instruction. Briefly, the plastic needle of the syringe will be inserted into the sulcus and the product will be progressively released in the periodontal pocket up to the gingival margin. The syringe will be then removed and a cotton pellet used to compact the gel into the sulcus. Patients will be then instructed not to floss or use interdental brushes in that area for the following 10 days.
PROCEDURE	Decontamination of the pocket with mechanical instrumentation	Gentle debridement will be performed under local anesthesia (mepivacain 2% 1:1000) for a time of 5 minutes by mean of ultrasonic devices by the same experienced clinician. Great attention will be made to avoid marginal and interproximal soft tissue damage.

Timeline

• Start date: 2023-05-30
• Primary completion: 2024-07-01
• Completion: 2024-07-15
• First posted: 2023-05-26
• Last updated: 2024-08-01

Locations

1 site across 1 country: Italy