Influence of Local Doxycycline on the Outcomes of Periodontal Regeneration

• Sponsor: University of Turin, Italy (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05878353
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Diseases	Procedure: Decontamination of the pocket with local doxycycline; Procedure: Decontamination of the pocket with mechanical instrumentation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Influence of Local Doxycycline on the Inflammatory Status of Intrabony Defects and Clinical Outcomes of Periodontal Regeneration: a Randomized Controlled Trial
• Actual Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subgingival instrumentation plus local doxycycline Gentle debridement plus local doxycycline administered 2 weeks prior to periodontal regeneration.	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.
Active Comparator: Subgingival instrumentation alone Gentle debridement alone performed 2 weeks prior to periodontal regeneration.	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.

Outcome Measures

Primary Outcome Measures

1. Clinical attachment level change [12 months]

   Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Secondary Outcome Measures

1. Radiographic bone level change [12 months]

   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)

2. Probing pocket depth change [12 months]

   Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

3. Bleeding on probing reduction [12 months]

   Bleeding on probing will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 1. diagnosis of Stage III or IV periodontitis (Tonetti et al. 2018);
• 1. FMPS and FMBS < 15% at the time of enrollment;
• 1. etiological periodontal therapy completed at least 3 months prior to screening;
• 1. 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;
• 1. smoking habits (> 10 cigarettes/day);
• 1. contraindications for periodontal surgery;
• 1. systemic diseases affecting periodontal healing;
• 1. pregnancy and lactation;
• 1. history of periodontal surgery at the experimental teeth;
• 1. allergies to doxycycline and tetracyclines;
• 1. assumption of antibiotics in the last 3 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CIR Dental School	Turin		Italy	10126

Sponsors and Collaborators

• University of Turin, Italy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Turin, Italy
• ClinicalTrials.gov Identifier: NCT05878353
• Other Study ID Numbers: DoxyTurin
• First Posted: May 26, 2023
• Last Update Posted: May 26, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Periodontal Diseases; Doxycycline

Study Results

No Results Posted as of May 26, 2023