Study design and population, inclusion, and exclusion criteria
painful experiencepregnancy
PLAQUE
This investigation was designed as a triple-blind RCT with a follow-up of 12 months. The study was registered at clinicaltrials.gov as NCT03258996. Patients were recruited (AFJ) among those attending the Master in Periodontics and Osseointegration at the University of the Basque Country (UPV/EHU) (Spain) between December 2017 and February 2020. During the first visit, potential participants were consecutively screened to determine their eligibility according to the following inclusion and exclusion criteria:Inclusion criteria:Age > 18 yearsMultiple Miller class III [Periodontal plastic surgery indicated for esthetic reasons, recurrent inflammation, progressive recession or dentin hypersensitivityAbsence of active periodontal pathologyFull-mouth plaque index (FMPI) [Exclusion criteria:Smokers of ≥ 10 cigarettes/daySystemic conditions that contraindicated surgeryThe use of analgesic and/or anti-inflammatory drugs in the last 72 hThe use of opioid drugs, anticonvulsants and/or antidepressants, except selective serotonin inhibitors, i.e., those drugs that act by reducing the painful experiencepregnancy or nursing womenThis study protocol was approved by the Ethics Committee of the UPV/EHU (M10/2017/042). All patients gave their informed consent, and all study procedures were performed according to the criteria included in the Declaration of Helsinki (1975; revised in 2013). The Consolidated Standards of Reporting (CONSORT) guidelines [