Insomnia and Post-Dental Surgery Pain: A Prospective Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
The purpose of this prospective observational study is to evaluate the relationship between preoperative sleep disturbances-specifically insomnia-and postoperative pain intensity following oral surgical procedures. Recent scientific literature highlights a bidirectional relationship between sleep disorders and pain in dentistry, suggesting that disturbed sleep may actively exacerbate subsequent pain perception. Although postoperative pain, swelling, and masticatory difficulties are common after dental extractions, clinical data investigating the direct impact of preoperative sleep quality on these surgical outcomes remain scarce. This study will enroll adult patients undergoing routine dental extractions and allocate them into two cohorts based on their baseline sleep quality: patients without preoperative sleep disturbances and patients with preoperative sleep disturbances. Pain levels and sleep parameters will be assessed using validated questionnaires before the surgery and at a 7-day follow-up. The primary objective is to determine whether the presence of preoperative insomnia leads to a significant increase in perceived postoperative surgical pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over or egual 18 years.
Need for odontoiatric surgical intervention (dental extractions).
Willingness to participate in the study by completing the proposed questionnaires.
Good understanding of the Italian language.
Disqualifiers
Pharmacological therapy interfering with sleep or pain at the time of recruitment.
Acute pain or ongoing infections at the time of recruitment.
Relevant comorbidities.
Pregnancy.
Trial population
The study population consists of an adult population of both sexes, aged 18 years or older, who are scheduled to undergo an odontoiatric surgical intervention, specifically dental extractions, at the Fondazione Policlinico Universitario A. Gemelli IRCCS. This population will be selected based on specific eligibility criteria and will be divided into two distinct cohorts at baseline to evaluate the impact of sleep health on surgical outcomes: Group 1 (Control Cohort): Adult patients undergoing dental extractions who do not exhibit preoperative sleep disturbances. Group 2 (Exposed Cohort): Adult patients undergoing dental extractions who present with pre-existing preoperative sleep disturbances.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
90 Participants
are grouped into 2 trial groupsGroup A: Patients without preoperative sleep disturbance
Group B: Patients with preoperative sleep disturbance
Trial outcomes
Primary outcomes
1
Change in Perceived Pain Intensity (VAS)
Perceived pain evaluated using the Visual Analog Scale (VAS 0-100), where higher scores indicate greater pain intensity. The outcome is measured as the change in pain score from baseline to 7 days post-extraction.
Time frame
Baseline (pre-surgery) and 7 days post-dental extraction.Secondary outcomes
1
Analgesic Medication Use
Monitoring the daily frequency of intake and the specific type of analgesic medication used, recorded through a daily paper diary.
Time frame
Daily, for 7 days following the surgical procedure.2
Insomnia Severity Index (ISI) Score
Assessment of insomnia severity using the validated 7-item ISI questionnaire (total score ranges from 0 to 28; scores $\\ge 15$ indicate clinically significant insomnia).
Time frame
Baseline (pre-surgery) and 7 days post-surgery.Sponsors and contacts
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Source ClinicalTrials.gov