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Completed

NCT Number: NCT05820867

Comparing OHRQoL: One or Two Sessions for Wisdom Teeth Removal

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.

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Key information

Conditions

Impacted Third Molar Tooth Behavior Health Behavior Impacted Tooth Patient Preference Patient Satisfaction Stomatognathic Diseases Tooth Diseases Tooth, Impacted Treatment Adherence and Compliance

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

Single-Session Bilateral Mandibular Third Molar Extraction

Procedure

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.

Two-Session Bilateral Mandibular Third Molar Extraction

Procedure

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.

Primary outcomes

  1. Change from baseline oral health-related quality of life at 14 days

    Time frame: 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 outcomes

  1. Change from baseline postoperative pain at 14 days

    Time frame: 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.

  2. Change in maximum interincisal opening

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Apr 20, 2023
Registry last updated
Apr 20, 2023

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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