Influence of Local Doxycycline on the Outcomes of Periodontal Regeneration

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05878353
• Other study ID #: DoxyTurin
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: January 2024
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: February 15, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1) diagnosis of Stage III or IV periodontitis (Tonetti et al. 2018);

• 2) FMPS and FMBS < 15% at the time of enrollment;

• 3) etiological periodontal therapy completed at least 3 months prior to screening;

• 4) presence of one natural tooth having a vertical defect with residual PPD = 6 mm and a radiographic intrabony component = 3 mm and BoP + requiring periodontal regenerative surgery.

Exclusion Criteria:

• 1) age < 18 years;

• 2) smoking habits (> 10 cigarettes/day);

• 3) contraindications for periodontal surgery;

• 4) systemic diseases affecting periodontal healing;

• 5) pregnancy and lactation;

• 6) history of periodontal surgery at the experimental teeth;

• 7) allergies to doxycycline and tetracyclines;

• 8) assumption of antibiotics in the last 3 months.

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	CIR Dental School	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level change	Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)	12 months
Secondary	Radiographic bone level change	Periapical standardized radiographs will be taken by a clinician masked to the clinical measurements using the paralleling technique and individually customized bite-blocks (RINN XCP Film Holding Instruments, Dentsply, York, USA)	12 months
Secondary	Probing pocket depth change	Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)	12 months
Secondary	Bleeding on probing reduction	Bleeding on probing will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)	12 months