Computational protocol: Scaling and root planning, and locally delivered minocycline reduces the load of Prevotella intermedia in an interdependent pattern, correlating with symptomatic improvements of chronic periodontitis: a short-term randomized clinical trial

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Protocol publication

[…] All the subjects were recruited from the Affiliated Hospital of Stomatology of Zhejiang University from June 2013 to September 2014. All teeth of the subjects underwent periodontal examination. PD, clinical attachment, and bleeding on probing (BOP) were recorded at six sites (buccal-mesial, mid-buccal, buccal-distal, lingual-mesial, mid-lingual, and lingual-distal) of teeth. The inclusion criteria were: the CP group diagnosed with moderate or severe chronic periodontal disease who exhibited BOP and attachment loss, with radiographic alveolar bone loss in four or more teeth (PD ≥4 mm, clinical attachment ≥3 mm). Patients were excluded if they were pregnant, had used antibiotics within the last 3 months, had periodontal therapy in the past 6 months, or had systemic diseases such as heart disease or hypertension. Two experienced periodontists performed the clinical examination in this selection procedure. The examiners were blinded to the assignment of interventions.Participants were randomly assigned to one of the three treatment groups: 1) SRP treatment alone; 2) locally delivered 2% MO alone (Perio® ointment, Sunstar Inc, Osaka, Japan); or 3) SRP treatment with a following adjunctive use of locally delivered 2% MO (SRP + MO). The minimal inhibitory concentration of MO was <0.1 μg/mL for Pg, <0.39 μg/mL for Pi, and <0.78 μg/mL for Fn. Pharmacological analysis revealed that the MO released from the MO ointment reached 1,400 μg/mL 1 hour postadministration in gingival crevicular fluid from periodontitic sockets. The concentration decreased with time and retained 1.59 μg/mL 5 days post-administration. The randomization process was performed using SPSS 16.0 software (IBM, Chicago, IL, USA) by a computer-generated randomly permuted block. The randomized distribution resulted in comparable mean values of all investigated parameters in all groups. We estimated the sample size by examining previous publications with a similar clinical grouping. To ensure a sufficient power in this trial, we adopted around 21–26 participants per group, which was more than that in a previous report (13 participants per group). We tested the power with the adopted sample size. For example, the mean PD changes (mm) of SRP, MO, and SRP + MO group were −0.65, −0.55, and −1.05. Basing on the given sample size in each group, the effect size f was 0.401. Using G*Power (version 3.1.9.2) software to perform the calculation, the power for a one-way analysis of variance (ANOVA) analysis was then 0.845, which was higher than the required 0.80. Consequently, the power analysis for these parameters confirmed the adequacy of the sample size in our study. The CONSORT (Consolidated Standards of Reporting Trials) study flowchart is outlined in . […]

Pipeline specifications

Software tools SPSS, G*Power
Application Miscellaneous
Organisms Prevotella intermedia, Aggregatibacter actinomycetemcomitans, Fusobacterium nucleatum, Porphyromonas gingivalis, Homo sapiens
Diseases Gingival Pocket, Chronic Periodontitis
Chemicals Minocycline