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Metronidazole in periodontal surgical therapy

Adjunctive efficacy of systemic metronidazole in the surgical treatment of periodontitis: a randomized placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12151923
Enrollment
50
Registered
2020-12-04
Start date
2015-02-10
Completion date
Unknown
Last updated
2022-10-10

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

Conditions

Severe generalised chronic periodontitis (generalised stages III-IV, grades B-C periodontitis) Oral Health Chronic periodontitis

Interventions

Participants are randomly assigned to treatment groups in ascending order, at the time of surgery, according to a balanced distribution system (random block design, block size = 6). 1.
CAL, calculated as the sum/rest of PD and REC
bleeding on probing (BOP), assessed dichotomously. Plaque index (PlI) is also assessed. In each quadrant, the most accessible location with the deepest PD and BOP is selected. Subgingival plaque sampl

Sponsors

Pontificia Universidad Católica Madre y Maestra
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Severe generalized chronic periodontitis (Armitage, 1999), corresponding to generalized stage III-IV periodontitis, with grades B-C (Caton et al., 2018; Papapanou et al., 2018; Tonetti, Greenwell, & Kornman, 2018) 2. A least 10 teeth in function, excluding third molars 3. Sites with PD> 5 mm, in =2 teeth in =1 quadrant 4. Radiographic evidence of bone loss =30% in, at least, 30% of the dentition 5. Older than 18 years

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women 2. Systemic diseases and/or chronic medications that may affect the periodontal status and /or requiring antibiotic prophylaxis 3. Having received systemic antimicrobial treatment in the previous 3 months 4. Have received periodontal treatment in the 6 months prior to the start of the study 5. Allergic to metronidazole, or to any of the components of their commercial formulations (Metrex 500 mg®, Laboratorio Union SRL, Santo Domingo, República Dominicana) 6. Refuse to sign the informed consent 7. Smokers =10 cigarettes/day

Design outcomes

Primary

MeasureTime frame
Probing Depth (PD), measured using a UNC-15 mm periodontal probe (Hu-Friedy, Leinmen, Germany) at baseline and 12-month visit

Secondary

MeasureTime frame
At baseline, 3 months after the last surgery session, and then after 6 and 12 months: 1. Probing Depth distribution [/overgrowth (measured to the nearest millimeter), Clinical Attachment Loss (calculated as the sum/rest of PD and REC) and open pockets measured using a UNC-15 mm periodontal probe (Hu-Friedy, Leinmen, Germany) 2. Plaque Index recorded using the O'Leary Index 3. Bleeding on Probing measured using a dichotomous analysis (presence or absence) 4. Microbiological variables (frequency of detection and counts of each targeted bacteria) samples analysed by multiplex quantitative polymerase chain reaction (qPCR), at baseline and after 12 months following surgical therapy

Countries

Dominican Republic

Outcome results

None listed

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