Back to resultsInfluence of Local Doxycycline on the Outcomes of Periodontal Regeneration
Primary Purpose
Periodontal Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Decontamination of the pocket with local doxycycline
Decontamination of the pocket with mechanical instrumentation
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases
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.
Sites / Locations
- CIR Dental SchoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Subgingival instrumentation plus local doxycycline
Subgingival instrumentation alone
Arm Description
Gentle debridement plus local doxycycline administered 2 weeks prior to periodontal regeneration.
Gentle debridement alone performed 2 weeks prior to periodontal regeneration.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
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)
Full Information
NCT ID
NCT05878353
First Posted
May 17, 2023
Last Updated
October 17, 2023
Sponsor
University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT05878353
Brief Title
Influence of Local Doxycycline on the Outcomes of Periodontal Regeneration
Official Title
Influence of Local Doxycycline on the Inflammatory Status of Intrabony Defects and Clinical Outcomes of Periodontal Regeneration: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Actual)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Turin, Italy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Subgingival instrumentation plus local doxycycline
Arm Type
Experimental
Arm Description
Gentle debridement plus local doxycycline administered 2 weeks prior to periodontal regeneration.
Arm Title
Subgingival instrumentation alone
Arm Type
Active Comparator
Arm Description
Gentle debridement alone performed 2 weeks prior to periodontal regeneration.
Intervention Type
Procedure
Intervention Name(s)
Decontamination of the pocket with local doxycycline
Intervention Description
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
Intervention Name(s)
Decontamination of the pocket with mechanical instrumentation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical attachment level change
Description
Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Radiographic bone level change
Description
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)
Time Frame
12 months
Title
Probing pocket depth change
Description
Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Time Frame
12 months
Title
Bleeding on probing reduction
Description
Bleeding on probing will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Aimetti, PA
Phone
011 6331546
Ext
0039
Email
mario.aimetti@unito.it
Facility Information:
Facility Name
CIR Dental School
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Aimetti, Prof.
Phone
+39116331541
Email
mario.aimetti@unito.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Influence of Local Doxycycline on the Outcomes of Periodontal Regeneration
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