Influence of Local Doxycycline on the Outcomes of Periodontal Regeneration

NCT ID: NCT05878353

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-30
• Study Completion Date: 2024-07-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Subgingival instrumentation plus local doxycycline

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

Group Type: EXPERIMENTAL

Decontamination of the pocket with local doxycycline

Intervention Type: 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 alone

Gentle debridement alone performed 2 weeks prior to periodontal regeneration.

Group Type: ACTIVE_COMPARATOR

Decontamination of the pocket with mechanical instrumentation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CIR Dental School

Turin, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 39868481 (View on PubMed)

Other Identifiers

DoxyTurin

Identifier Type: -

Identifier Source: org_study_id