Comparing OHRQoL: One or Two Sessions for Wisdom Teeth Removal

Sponsor

Marmara University (Other)

Overall Status

Completed

CT.gov ID

NCT05820867

Collaborator

(none)

Enrollment

Location

Arms

42.1

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Impacted Third Molar Tooth Impacted Tooth	Procedure: Single-Session Bilateral Mandibular Third Molar Extraction Procedure: Two-Session Bilateral Mandibular Third Molar Extraction	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Prospective Comparison of Single vs. Staged Extractions: OHRQoL Outcomes for Wisdom Teeth Removal

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Single-session arm	Procedure: Single-Session Bilateral Mandibular Third Molar Extraction Participants in this group chose to have both of their lower mandibular third molars extracted during a single appointment. This group will be used to compare the impact of single-session extraction on patients' oral health-related quality of life, postoperative pain, and maximum interincisal opening.
Active Comparator: Two-session arm	Procedure: Two-Session Bilateral Mandibular Third Molar Extraction Participants in this group chose to have their lower mandibular third molars extracted during two separate appointments. This group will be used to compare the impact of two-session extraction on patients' oral health-related quality of life, postoperative pain, and maximum interincisal opening.

Arm

Intervention/Treatment

Active Comparator: Single-session arm

Procedure: Single-Session Bilateral Mandibular Third Molar Extraction

Participants in this group chose to have both of their lower mandibular third molars extracted during a single appointment. This group will be used to compare the impact of single-session extraction on patients' oral health-related quality of life, postoperative pain, and maximum interincisal opening.

Active Comparator: Two-session arm

Procedure: Two-Session Bilateral Mandibular Third Molar Extraction

Participants in this group chose to have their lower mandibular third molars extracted during two separate appointments. This group will be used to compare the impact of two-session extraction on patients' oral health-related quality of life, postoperative pain, and maximum interincisal opening.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).