NCT05820867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

March 25, 2023

Last Update Submit

April 6, 2023

Conditions

Impacted Third Molar ToothImpacted Tooth

Keywords

Quality of LifeOral healthProspective StudiesMolar, ThirdTooth ExtractionPatient Preference

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, postoperative day 2, day 3, day 7, day 9, and day 14

Secondary Outcomes (2)

  • Change from baseline postoperative pain at 14 days

    Postoperative 6th hour, 12th hour, day 2, day 3, day 7, day 9, and day 14

  • Change in maximum interincisal opening

    Baseline and postoperative day 7

Study Arms (2)

Single-session arm

ACTIVE COMPARATOR
Procedure: Single-Session Bilateral Mandibular Third Molar Extraction

Two-session arm

ACTIVE COMPARATOR
Procedure: Two-Session Bilateral Mandibular Third Molar Extraction

Interventions

Single-Session Bilateral Mandibular Third Molar ExtractionPROCEDURE

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.

Single-session arm
Two-Session Bilateral Mandibular Third Molar ExtractionPROCEDURE

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.

Two-session arm

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (8)

  • Friedman JW. The prophylactic extraction of third molars: a public health hazard. Am J Public Health. 2007 Sep;97(9):1554-9. doi: 10.2105/AJPH.2006.100271. Epub 2007 Jul 31.

    PMID: 17666691BACKGROUND

  • Meng L, Hua F, Bian Z. Coronavirus Disease 2019 (COVID-19): Emerging and Future Challenges for Dental and Oral Medicine. J Dent Res. 2020 May;99(5):481-487. doi: 10.1177/0022034520914246. Epub 2020 Mar 12.

    PMID: 32162995BACKGROUND

  • Long RH, Ward TD, Pruett ME, Coleman JF, Plaisance MC Jr. Modifications of emergency dental clinic protocols to combat COVID-19 transmission. Spec Care Dentist. 2020 May;40(3):219-226. doi: 10.1111/scd.12472. Epub 2020 May 24.

    PMID: 32447777BACKGROUND

  • Holland IS, Stassen LF. Bilateral block: is it safe and more efficient during removal of third molars? Br J Oral Maxillofac Surg. 1996 Jun;34(3):243-7. doi: 10.1016/s0266-4356(96)90278-8.

    PMID: 8818259BACKGROUND

  • Deepti C, Rehan HS, Mehra P. Changes in quality of life after surgical removal of impacted mandibular third molar teeth. J Maxillofac Oral Surg. 2009 Sep;8(3):257-60. doi: 10.1007/s12663-009-0063-2. Epub 2009 Nov 21.

    PMID: 23139521BACKGROUND

  • Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.

    PMID: 9332805BACKGROUND

  • College C, Feigal R, Wandera A, Strange M. Bilateral versus unilateral mandibular block anesthesia in a pediatric population. Pediatr Dent. 2000 Nov-Dec;22(6):453-7.

    PMID: 11132502BACKGROUND

  • 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.

    PMID: 25069437BACKGROUND

MeSH Terms

Conditions

Tooth, ImpactedPatient Preference

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesPatient SatisfactionTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

March 25, 2023

First Posted

April 20, 2023

Study Start

March 1, 2018

Primary Completion

March 1, 2020

Study Completion

September 1, 2021

Last Updated

April 20, 2023

Record last verified: 2023-04

Locations

TU(1)