Back to resultsComparing OHRQoL: One or Two Sessions for Wisdom Teeth Removal
Primary Purpose
Impacted Third Molar Tooth, Impacted Tooth
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Single-Session Bilateral Mandibular Third Molar Extraction
Two-Session Bilateral Mandibular Third Molar Extraction
Sponsored by
About this trial
This is an interventional treatment trial for Impacted Third Molar Tooth focused on measuring Quality of Life, Oral health, Prospective Studies, Molar, Third, Tooth Extraction, Patient Preference
Eligibility Criteria
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).
Sites / Locations
- Marmara University School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Single-session arm
Two-session arm
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05820867
Brief Title
Comparing OHRQoL: One or Two Sessions for Wisdom Teeth Removal
Official Title
Prospective Comparison of Single vs. Staged Extractions: OHRQoL Outcomes for Wisdom Teeth Removal
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
September 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth, Impacted Tooth
Keywords
Quality of Life, Oral health, Prospective Studies, Molar, Third, Tooth Extraction, Patient Preference
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-session arm
Arm Type
Active Comparator
Arm Title
Two-session arm
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Single-Session Bilateral Mandibular Third Molar Extraction
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Two-Session Bilateral Mandibular Third Molar Extraction
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline oral health-related quality of life at 14 days
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline postoperative pain at 14 days
Description
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
Title
Change in maximum interincisal opening
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
Marmara University School of Dentistry
City
Istanbul
ZIP/Postal Code
34854
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17666691
Citation
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.
Results Reference
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PubMed Identifier
32162995
Citation
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.
Results Reference
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PubMed Identifier
32447777
Citation
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.
Results Reference
background
PubMed Identifier
8818259
Citation
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.
Results Reference
background
PubMed Identifier
23139521
Citation
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.
Results Reference
background
PubMed Identifier
9332805
Citation
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.
Results Reference
background
PubMed Identifier
11132502
Citation
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.
Results Reference
background
PubMed Identifier
25069437
Citation
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.
Results Reference
background
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Comparing OHRQoL: One or Two Sessions for Wisdom Teeth Removal
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