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Not Yet Recruiting NCT07712432

Insomnia and Post-Dental Surgery Pain: A Prospective Study

Conditions: Dental, Dental Extraction, Insomnia

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 90
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Location: Clinica Odontoiatrica; Fondazione Universitaria Policlinico A.Gemelli IRCCS Roma

Summary

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

Inclusion Criteria: * 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. * Ability to understand and sign the informed consent form. Exclusion Criteria: * 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. * Impossibility to complete the follow-up.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07712432). StuddyBuddy aggregates publicly available trial information.