Difficulty, Time & M3 Surgery Outcomes

NCT07296172 | Completed

• 1 other identifier: GO 15/556
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational cohort study is designed to evaluate early postoperative complications and patient-reported satisfaction following surgical extraction of impacted mandibular third molars under local anesthesia in adult patients. Standardized surgical and postoperative protocols are applied to all participants. The primary objective is to assess overall patient satisfaction on postoperative day 7 using a structured questionnaire. Secondary objectives are to describe the frequency and characteristics of early postoperative pain, swelling, trismus and other complications in the first postoperative week after surgery.

Conditions

Third Molar Extraction Surgery; Third Molar Impaction; Satisfaction Survey

Outcome Measures

Primary Outcomes (1)

• Total score on a 20-item postoperative patient satisfaction questionnaire following surgical extraction of impacted mandibular third molars

  Patient satisfaction will be assessed on postoperative day 7 using a 20-item postoperative mandibular third molar surgery patient satisfaction questionnaire. The questionnaire evaluates domains such as pain control, swelling, mouth opening, intraoperative and postoperative comfort, information provided by the surgeon, ability to chew and perform daily activities, willingness to undergo the procedure again, and overall satisfaction with care. Each item is rated on a 5-point Likert-type scale (1 = lowest satisfaction, 5 = highest satisfaction). A total satisfaction score will be calculated by summing all item scores, resulting in a minimum total score of 20 and a maximum total score of 100.

  day 7

Secondary Outcomes (1)

• Incidence and severity of early postoperative complications after surgical extraction of impacted mandibular third molars

  day 7

Study Arms (1)

Patients undergoing surgical extraction of impacted mandibular third molars

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the Department of Oral and Maxillofacial Surgery at Hacettepe University for surgical removal of an impacted mandibular third molar under local anesthesia. Eligible participants are generally healthy (ASA I-II), present with a single impacted mandibular third molar indicated for extraction, and are able to attend the postoperative day-7 follow-up visit and complete all study questionnaires.

You may qualify if:

• Presence of one impacted mandibular third molar indicated for surgical extraction
• Surgical removal of the impacted mandibular third molar planned under local anesthesia
• Good general health (ASA I-II)
• Ability to understand the study information and provide written informed consent
• Willingness and ability to attend the postoperative day-7 follow-up visit and to complete all study questionnaires

You may not qualify if:

• Systemic diseases corresponding to ASA III or higher
• Acute infection at the surgical site (e.g. acute pericoronitis, abscess) requiring emergency treatment
• Previous surgical intervention at the same mandibular third molar region
• Pregnancy or lactation
• History of radiotherapy or chemotherapy involving the head and neck region
• Known bleeding disorders or current use of anticoagulant medication that cannot be safely modified for surgery
• Chronic use of systemic corticosteroids, immunosuppressive drugs, or long-term analgesic therapy that may interfere with pain assessment or healing
• Known allergy or contraindication to the local anesthetic or routinely used postoperative medications in this study
• Significant cognitive or psychiatric disorders, or language barriers that prevent reliable completion of the questionnaires

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant prof

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 22, 2025
• Study Start: January 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)