An interventional study of Single-Session Bilateral Mandibular Third Molar Extraction and Two-Session Bilateral Mandibular Third Molar Extraction in Impacted Third Molar Tooth and Impacted Tooth, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-20.
Sponsored by Marmara University · Not applicable, Interventional, and Treatment
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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This study's enrollment of 59 is above the median of 53 across 164 interventional studies indexed under Tooth, Impacted.
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Exclusion Criteria:
Procedure: Single-Session Bilateral Mandibular Third Molar Extraction
Procedure: Two-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.
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.
Change from baseline oral health-related quality of life at 14 days
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.
Time frame: Baseline, postoperative day 2, day 3, day 7, day 9, and day 14
Change from baseline postoperative pain at 14 days
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.
Time frame: Postoperative 6th hour, 12th hour, day 2, day 3, day 7, day 9, and day 14
Change in maximum interincisal opening
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.
Time frame: Baseline and postoperative day 7
Plan to share: Undecided
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Marmara University