Comparing OHRQoL: One or Two Sessions for Wisdom Teeth Removal

Not Applicable

Completed

• Conditions: Impacted Third Molar Tooth; Impacted Tooth
• Interventions: Procedure: Single-Session Bilateral Mandibular Third Molar Extraction; Procedure: Two-Session Bilateral Mandibular Third Molar Extraction

• Registration Number: NCT05820867
• Lead Sponsor: Marmara University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2020-03-01
• Study Completion: 2021-09-01
• Study First Submitted: 2023-03-25
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-06
• Last Update Submitted: 2023-04-06
• Study First Posted: 2023-04-20
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-session arm	Single-Session Bilateral Mandibular Third Molar Extraction	-
Two-session arm	Two-Session Bilateral Mandibular Third Molar Extraction	-

Primary Outcome Measures

Name	Time	Method
Change from baseline oral health-related quality of life at 14 days	Baseline, postoperative day 2, day 3, day 7, day 9, and day 14	The Oral Health Impact Profile-14 (OHIP-14) questionnaire is used to evaluate the participants' oral health-related quality of life. The OHIP-14 is a validated instrument that assesses the perceived impact of oral conditions on an individual's well-being across 14 items, each scored on a 5-point Likert scale. Lower scores indicate better OHRQoL.

Secondary Outcome Measures

Name	Time	Method
Change from baseline postoperative pain at 14 days	Postoperative 6th hour, 12th hour, day 2, day 3, day 7, day 9, and day 14	The Visual Analog Scale (VAS) is used to assess the intensity of postoperative pain experienced by participants. The VAS is a validated tool consisting of a horizontal or vertical line, usually 100 mm in length, with anchor points of "no pain" at one end and "worst imaginable pain" at the other. Participants are asked to mark the point on the line that corresponds to their pain level. Higher scores indicate greater pain intensity.
Change in maximum interincisal opening	Baseline and postoperative day 7	Maximum interincisal opening (MIO) is being measured to evaluate trismus, or restricted mouth opening, following the extraction of mandibular third molars. MIO measurements are taken using a ruler to measure the distance between the upper and lower central incisors when the participant opens their mouth as wide as possible. Lower values indicate greater trismus.

Trial Locations

Locations (1)

Marmara University School of Dentistry; 🇹🇷 Istanbul, Turkey