Metronidazole in periodontal surgical therapy

Not Applicable

Completed

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

• Registration Number: ISRCTN12151923
• Lead Sponsor: Pontificia Universidad Católica Madre y Maestra

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35122549/ (added 14/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-05-15
• Study Start: 2020-12-04
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> At baseline, 3 months after the last surgery session, and then after 6 and 12 months:<br> 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)<br> 2. Plaque Index recorded using the O'Leary Index<br> 3. Bleeding on Probing measured using a dichotomous analysis (presence or absence)<br><br> 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<br>