Insomnia and Post-Dental Surgery Pain: A Prospective Study

NCT07712432 | Not Yet Recruiting

• 1 other identifier: 27211
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental; Dental Extraction; Insomnia

Keywords

Insomnia; Oral disease

Outcome Measures

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.

  Baseline (pre-surgery) and 7 days post-dental extraction.

Secondary Outcomes (2)

• Analgesic Medication Use

  Daily, for 7 days following the surgical procedure.

• Insomnia Severity Index (ISI) Score

  Baseline (pre-surgery) and 7 days post-surgery.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Clinica Odontoiatrica; Fondazione Universitaria Policlinico A.Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Mouth Diseases

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Stomatognathic Diseases

Study Officials

• Patrizia Gallenzi

  Fondazione Policlinico A. Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Patrizia Gallenzi

CONTACT

+39 063015 5413; patrizia.gallenzi@unicatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)