Difficulty, Time & M3 Surgery Outcomes

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.

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Key information

Conditions

Third Molar Extraction Surgery Satisfaction Survey Third Molar Impaction

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

About this study

Adult patients requiring surgical removal of an impacted mandibular third molar under local anesthesia will be prospectively enrolled at a single oral and maxillofacial surgery center. All procedures will be performed using a standardized surgical technique and a uniform postoperative medication and care protocol. Clinical examinations and patient-reported outcome measures will be obtained at baseline and at the postoperative day-7 follow-up visit. The study focuses on describing the early postoperative course after third molar surgery and on exploring how early complications relate to overall patient satisfaction with treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

Time frame: day 7

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.

Secondary outcomes

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

Time frame: day 7

Early postoperative complications will be evaluated within the first postoperative week. Complications of interest include pain, facial swelling, trismus (limited mouth opening), prolonged bleeding, dry socket, infection at the surgical site, and neurosensory disturbances in the lower lip or chin region. At the postoperative day-7 visit, each complication will be recorded as present or absent based on clinical examination and patient report, and its severity will be classified descriptively (e.g. mild, moderate, severe). The proportion of patients experiencing each complication and any complication will be calculated.

Sponsors and collaborators

Lead sponsor

Bahçeşehir University

Other

Registry information

Official study title

Surgical Difficulty and Operation Time as Determinants of Outcomes in Mandibular Third Molar Surgery

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Dec 22, 2025
Registry last updated: Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed