Influence of Local Doxycycline on the Outcomes of Periodontal Regeneration

NCT05878353 | Completed

• 1 other identifier: DoxyTurin
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Radiographic bone level change

  12 months

• Probing pocket depth change

  12 months

• Bleeding on probing reduction

  12 months

Study Arms (2)

Subgingival instrumentation plus local doxycycline

EXPERIMENTAL

Gentle debridement plus local doxycycline administered 2 weeks prior to periodontal regeneration.

Procedure: Decontamination of the pocket with local doxycycline

Subgingival instrumentation alone

ACTIVE COMPARATOR

Gentle debridement alone performed 2 weeks prior to periodontal regeneration.

Procedure: Decontamination of the pocket with mechanical instrumentation

Interventions

Decontamination of the pocket with local doxycycline PROCEDURE

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.

Subgingival instrumentation plus local doxycycline

Decontamination of the pocket with mechanical instrumentation PROCEDURE

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.

Subgingival instrumentation alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) diagnosis of Stage III or IV periodontitis (Tonetti et al. 2018);
• \) FMPS and FMBS \< 15% at the time of enrollment;
• \) etiological periodontal therapy completed at least 3 months prior to screening;
• \) 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.

You may not qualify if:

• \) age \< 18 years;
• \) smoking habits (\> 10 cigarettes/day);
• \) contraindications for periodontal surgery;
• \) systemic diseases affecting periodontal healing;
• \) pregnancy and lactation;
• \) history of periodontal surgery at the experimental teeth;
• \) allergies to doxycycline and tetracyclines;
• \) assumption of antibiotics in the last 3 months.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

CIR Dental School

Turin, 10126, Italy

Location

Related Publications (1)

• Aimetti M, Baima G, Lorenzetti V, Aliyeva N, Bottone M, Mariani GM, Romano F. A BiO-Optimizing Site Targeted (BOOST) Approach to Periodontal Regeneration Through Local Doxycycline Prior to Surgery: A Randomized Clinical Trial. J Periodontal Res. 2025 Jan 27. doi: 10.1111/jre.13389. Online ahead of print.

  PMID: 39868481 DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 26, 2023
• Study Start: May 30, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 15, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)