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Effect of Insomnia on Post-operative Dental Surgical Pain: a Prospective Observational Study in an Adult Population.

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Clinica Odontoiatrica; Fondazione Universitaria Policlinico A.Gemelli IRCCS
RECRUITING
Roma
Contact Information
Primary
Prof. Patrizia Gallenzi
patrizia.gallenzi@unicatt.it
+39 063015 5413
Time Frame
Start Date: 2026-09-01
Estimated Completion Date: 2027-06
Participants
Target number of participants: 90
Treatments
Patients without preoperative sleep disturbance
Adult patients undergoing dental extractions who do not exhibit preoperative sleep disturbances. Target Number: 45 participants.
Patients with preoperative sleep disturbance
Adult patients undergoing dental extractions who exhibit preoperative sleep disturbances. Target number: 45 participants.
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov