Clinical trial NCT07027137: The Influence of Local Antibiotic Therapy on the Outcomes Following Periodontal Regeneration Procedures.
Official title: The Influence of Local Antibiotic Therapy on the Outcomes Following Periodontal Regeneration Procedures.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Periodontitis
Periodontal Diseases
Keywords: periodontitis
periodontal regeneration
local antibiotics
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study group consisted of 20 people participants who underwent the SRP procedure (scaling and root planing) performed with the subsequent application of local antibiotics (10% doxycycline) into periodontal pockets at the site of the planned surgical intervention, while in the control group SRP was performed alone. Two weeks after SRP, the M-MIST/MIST procedure was performed in both the test and control groups with the use of enamel matrix derivative (EMD). All surgical interventions were performed under local anesthesia (Septanest, Septodont, Paris, France). After intrabony defect exposure the granulation tissue was excised using the hand instruments (Gracey currettes (SMS), Hu-Friedy, Chicago, IL, USA), the root surface was conditioned with 24% EDTA (PrefGel®, Straumann, Switzerland) and defect was filled with enamel matrix derivative (Emdogain®, Straumann, Switzerland). Once procedure was completed, the mucoperiosteal flap was repositioned and stabilized with sutures.
Primary purpose: TREATMENT

Brief summary: Assessmnet of the influence of local antibiotic therapy on the clinical, radiological, microbiological parameters and the inflammation mediators levels in the gingival crevicular fluid (GCF) following periodontal regeneration procedures in patients with periodontitis.

Detailed description: Forty generally healthy adults diagnosed with stage III periodontitis were randomly divided into two groups. In the test group, SRP was performed with the subsequent application of local antibiotics (10% doxycycline) into periodontal pockets at the site of the planned surgical intervention, while in the control group SRP was performed alone. Two weeks after, on the day of the surgical treatment, the M-MIST/MIST procedure was performed in both the test and control groups with the use of enamel matrix derivative (EMD). Clinical examination was performed before and 6 and 12 months after treatment. For radiological measurements RVG was performed. For inflammation mediators levels determination in GCF samples ELISA method will be used. For microbiological assessments Real Time PCR method will be used.

Eligibility criteria: Inclusion Criteria:

-presence of an intrabony defect, with a pocket depth (PD) ≥ 6 mm and a radiological defect depth of ≥3 mm and width of ≥2 mm;

Exclusion Criteria:

* periodontal treatment within 3 months prior to the study;
* antibiotic therapy within 3 months prior to the study;
* smoking; presence of systemic diseases affecting periodontal healing, i.e.: immunosuppressive diseases, diabetes, osteoporosis, AIDS, hypertension treated with calcium channel blockers;
* use of steroids or other immunosuppressive drugs;
* pregnant and breastfeeding women

Primary outcomes:
measure: Assessment of the influence of local antibiotic therapy on the clinical, outcomes following periodontal regeneration procedures.
timeFrame: up to 12 months after treatment procedure
Secondary outcomes:
measure: Assessment of the influence of local antibiotic therapy on the radiological outcomes following periodontal regeneration procedures.
timeFrame: up to 12 months after treatment procedure
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Department of Integrated Dentistry, Medical University of Białystok
state: Podlaskie
Study officials:
References: