Clinical trial NCT05820867: Comparing OHRQoL: One or Two Sessions for Wisdom Teeth Removal
Official title: Prospective Comparison of Single vs. Staged Extractions: OHRQoL Outcomes for Wisdom Teeth Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impacted Third Molar Tooth
Impacted Tooth
Keywords: Quality of Life
Oral health
Prospective Studies
Molar, Third
Tooth Extraction
Patient Preference
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single-center prospective cohort study includes patients aged 18-30 years aimed to compare the effects of bilateral extraction of wisdom teeth at a single appointment (Group A) versus two separate appointments (Group B) on patients' oral health-related quality of life (OHRQoL). The primary outcome is Oral Health Impact Profile 14 score, while secondary outcomes included postoperative pain and maximum interincisal opening.


Eligibility criteria: Inclusion Criteria:

* Patients referred to the Oral and Maxillofacial Surgery Department for bilateral extraction of impacted mandibular third molars.
* Asymptomatic, impacted mandibular third molars.
* Impaction classified as Class I, Position A according to the Pell and Gregory classification.
* Patients with an ASA (American Society of Anesthesiologists) Physical Status Classification of ASA 1.

Exclusion Criteria:

* Local pathology associated with third molars (e.g., cysts or tumors).
* Diagnosis of acute pericoronitis.
* Usage of anti-inflammatory drugs or antibiotics within the last week.
* Operations requiring osteotomy.
* Patients with psychiatric disorders or taking drugs that may impair their mental health.
* Patients unwilling to undergo data collection procedures.
* Pregnant or lactating women.
* Heavy smokers.
* Operations lasting longer than 45 minutes for one side (from the time the first incision is made to the last suture placed).

Primary outcomes:
measure: Change from baseline oral health-related quality of life at 14 days
timeFrame: Baseline, postoperative day 2, day 3, day 7, day 9, and day 14
Secondary outcomes:
measure: Change from baseline postoperative pain at 14 days
timeFrame: Postoperative 6th hour, 12th hour, day 2, day 3, day 7, day 9, and day 14
measure: Change in maximum interincisal opening
timeFrame: Baseline and postoperative day 7
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Dentistry
Study officials:
References:
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citation: Coulthard P, Bailey E, Esposito M, Furness S, Renton TF, Worthington HV. Surgical techniques for the removal of mandibular wisdom teeth. Cochrane Database Syst Rev. 2014 Jul 29;(7):CD004345. doi: 10.1002/14651858.CD004345.pub2.