Periodontal DiseasesNCT05878353
Influence of Local Doxycycline on the Outcomes of Periodontal Regeneration
A study testing Decontamination of the pocket with local doxycycline and Decontamination of the pocket with mechanical instrumentation in people with Periodontal Diseases, run by University of Turin, Italy at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Decontamination of the pocket with local doxycycline and Decontamination of the pocket with mechanical instrumentation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 30 May 2023to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Local Doxycycline on the Inflammatory Status of Intrabony Defects and Clinical Outcomes of Periodontal Regeneration: a Randomized Controlled Trial
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
- Being tested
- Decontamination of the pocket with local doxycycline, Decontamination of the pocket with mechanical instrumentation
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decontamination of the pocket with local doxycyclineProcedure or surgery
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 instrumentationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Subgingival instrumentation plus local doxycycline | Experimental | Gentle debridement plus local doxycycline administered 2 weeks prior to periodontal regeneration. Receives: Procedure: Decontamination of the pocket with local doxycycline |
| Subgingival instrumentation alone | Active comparator | Gentle debridement alone performed 2 weeks prior to periodontal regeneration. Receives: Procedure: Decontamination of the pocket with mechanical instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (3)
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)
Measured: 12 months
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)
Measured: 12 months
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start30 May 2023
- Primary completion1 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878353
- Sponsor's protocol ID
- DoxyTurin
- Status last verified
- Jul 2024
- First submitted
- 17 May 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Jan;61(1):44-53. doi: 10.1111/jre.13389. Epub 2025 Jan 27.
PubMed 39868481
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Local Doxycycline on the Inflammatory Status of Intrabony Defects and Clinical Outcomes of Periodontal Regeneration: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05878353
- Acronym / sponsor ID
- DoxyTurin
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subgingival instrumentation plus local doxycycline | Experimental | Procedure: Decontamination of the pocket with local doxycyclineGentle debridement plus local doxycycline administered 2 weeks prior to periodontal regeneration. |
| Subgingival instrumentation alone | Active comparator | Procedure: Decontamination of the pocket with mechanical instrumentationGentle debridement alone performed 2 weeks prior to periodontal regeneration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decontamination of the pocket with local doxycyclineGentle 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. | Procedure or surgery | Subgingival instrumentation plus local doxycycline |
| Decontamination of the pocket with mechanical instrumentationGentle 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. | Procedure or surgery | Subgingival instrumentation alone |
Primary outcome
Clinical attachment level change
Time frame: 12 months
Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
3 secondary outcomes
Radiographic bone level change
Time frame: 12 months
Probing pocket depth change
Time frame: 12 months
Bleeding on probing reduction
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 39868481Aimetti 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. 2026 Jan;61(1):44-53. doi: 10.1111/jre.13389. Epub 2025 Jan 27.
- Individual participant dataSharing planned: No
Related trials for Periodontal Diseases
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decontamination of the pocket with local doxycycline and Decontamination of the pocket with mechanical instrumentation in people with Periodontal Diseases, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment level change (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05878353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.