Third Molar Extraction SurgeryNCT07296172
Difficulty, Time & M3 Surgery Outcomes
An observational study of Third Molar Extraction Surgery and Third Molar Impaction, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Third Molar Extraction Surgery, Third Molar Impaction, Satisfaction Survey
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 1 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Difficulty and Operation Time as Determinants of Outcomes in Mandibular Third Molar Surgery
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.
Read the detailed description
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing surgical extraction of impacted mandibular third molars | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 7
Secondary outcomes (1)
Incidence and severity of early postoperative complications after surgical extraction of impacted mandibular third molars
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.
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Jan 2017
- Primary completion1 May 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Third Molar Extraction SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara KAZAN, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296172
- Sponsor's protocol ID
- GO 15/556
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Difficulty and Operation Time as Determinants of Outcomes in Mandibular Third Molar Surgery
- ClinicalTrials.gov ID
- NCT07296172
- Acronym / sponsor ID
- GO 15/556
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing surgical extraction of impacted mandibular third molars | – | – |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Incidence and severity of early postoperative complications after surgical extraction of impacted mandibular third molars
Time frame: day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Third Molar Extraction Surgery and Third Molar Impaction, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score on a 20-item postoperative patient satisfaction questionnaire following surgical extraction of impacted mandibular third molars (time frame: day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.