Skip to content

Comparison of two adjunctive locally delivered antibiotic gel regimens for initial therapy in periodontitis patients

A placebo-controlled trial to evaluate two locally delivered antibiotic-containing (piperacillin and tazobactam verus doxycycline) gels in stage III-IV periodontitis patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN89207035
Enrollment
100
Registered
2022-10-21
Start date
2018-10-01
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Topical antibiotic gels applied adjunctively to subgingival instrumentation in stage III-IV periodontitis patients. Oral Health

Interventions

The study includes a cohort of 100 patients equally divided into one of the three groups - A, B, and C. Subjects will be selected from patients of the Department of Periodontology of the Victor Babes
Probing Pocket Depth (PPD) evaluation on the vestibular and oral surfaces will be performed halfway between the line angles using the PCP – UNC 15 periodontal probe (Hu–Friedy, Chicago, IL., USA). On
Overall Bleeding Index (BOP) evaluated in 6 sites per tooth at 30 seconds from the probing
Level of clinical attachment (CAL)
Teeth mobility degrees
Involvement of furcation (FI) in multi-rooted teeth, all sites with furcation involvement were included into grade I, II or III
all clinical measurements will be performed by one clinician using a Nabers probe. Data will be recorded in the periodontal sheet of the University of Bern (http://www.periodontalchart-online.com/uk/i

Sponsors

MegaGen Dental Implant Romania
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. All subjects were diagnosed with periodontitis stage III and IV 2. All participants fulfilled the following inclusion criteria: 2.1. Aged between 25 and 80 years old 2.2. At least 8 sites with PD = 5 mm and showing bleeding on probing 2.3. Clinical attachment loss =3 mm 2.4. Patients who have not undergone periodontal therapy in the last 12 months

Exclusion criteria

Exclusion criteria: Patients with the following conditions were excluded: 1. Clinically relevant psychiatric disorders 2. Alcohol consumption 3. Autoimmune disorders 4. HIV infection 5. Untreated diabetes mellitus 6. Pregnancy or breastfeeding 7. Patients who have received periodontal therapy in the last 12 months 8. Patients who reported local and/or systemic antibiotic therapy within the 3 months before the baseline examination of the study 9. Candidiasis 10. Allergies to piperacillin, tazobactam, doxycycline, or to any tetracycline or penicillin or to any excipient of the products used 11. Systemic medication that can influence the clinical features of periodontitis 12. Patients who have rinsed or irrigated with antiseptics less than a month before the initial examination 12. Conditions that require antibiotic protection

Design outcomes

Primary

MeasureTime frame
Periodontal pocket depth measured using a periodontal probe at baseline (initial evaluation) and 3 and 6 months after surgery

Secondary

MeasureTime frame
Secondary outcome variables were evaluated at 3 and 6 months: 1. Full mouth bleeding score (FMBS) recorded using 6 sites per tooth, mesiobuccal, midbuccal, distobuccal, disto-oral, midoral, and mesio-oral] using PCP-UNC15 probes (Hu-Friedy, Chicago, IL, USA) 2. Mean full mouth plaque score (FMPS) evaluated in 6 sites per tooth at 30 seconds from the survey 3. Overall bleeding index (BOP) evaluated in 6 sites per tooth at 30 seconds from the survey 4. Pocket closure defined as the transition of sites with PPD>5 mm or 4 mm with BOP to non-bleeding sites with PPD = 4 mm 5. Recession (REC) are recorded to the nearest millimeter at 6 sites per tooth. 6. Clinical attachment level (CAL) is calculated using the PD and REC values 7. Numbers of the following five keystone bacterial pathogens [using a molecular genetic analysis, micro–IDent A Test]: (baseline and 6 months): 7.1. Aggregatibacter actinomycetemcomitans 7.2. Porphyromonas gingivalis 7.3. Prevotella intermedia 7.4. Tannerella forsythia 7.5. Treponema denticola

Countries

Romania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026