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The Influence of Local Antibiotic Therapy on the Outcomes Following Periodontal Regeneration Procedures.

The Influence of Local Antibiotic Therapy on the Outcomes Following Periodontal Regeneration Procedures.

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07027137
Acronym
ANBperio
Enrollment
40
Registered
2025-06-18
Start date
2019-08-01
Completion date
2025-12-30
Last updated
2025-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases, Periodontitis

Keywords

periodontitis, periodontal regeneration, local antibiotics

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.

Interventions

DRUGSRP+ANB+SURG

SRP (scaling and root planing) with ANB (local antibiotic application- 10%doxycycline) and SURG (regeneration procedure according to MIST/M-MIST)

PROCEDURESRP+SURG

SRP (scaling and root planing) and SURG (regeneration procedure according to MIST/M-MIST)

Sponsors

Medical University of Bialystok
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of the influence of local antibiotic therapy on the clinical, outcomes following periodontal regeneration procedures.up to 12 months after treatment procedurePD (Pocket Depth) reduction- measured from the gingival margin to the bottom of the sulcus (mm) CAL (Clinical Attachment Level) gain- measured from the cemento-enamel junction to the bottom of the sulcus (mm)

Secondary

MeasureTime frameDescription
Assessment of the influence of local antibiotic therapy on the radiological outcomes following periodontal regeneration procedures.up to 12 months after treatment procedureRIDW- (radiological intrabony defect width)- measured from bone crest to the root surface (mm) RIDD - (radiologial intrabony defect depth) - measured from bone crest to the bottom of the defect (mm)

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026