Impacted Third Molar ToothNCT05820867
Comparing OHRQoL: One or Two Sessions for Wisdom Teeth Removal
A study testing Single-Session Bilateral Mandibular Third Molar Extraction and Two-Session Bilateral Mandibular Third Molar Extraction in people with Impacted Third Molar Tooth and Impacted Tooth, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth, Impacted Tooth
- What is being tested?
- Single-Session Bilateral Mandibular Third Molar Extraction and Two-Session Bilateral Mandibular Third Molar Extraction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Dentistry
Istanbul, 34854
About this study
Official title: Prospective Comparison of Single vs. Staged Extractions: OHRQoL Outcomes 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.
- Conditions
- Impacted Third Molar Tooth, Impacted Tooth
- Being tested
- Single-Session Bilateral Mandibular Third Molar Extraction, Two-Session Bilateral Mandibular Third Molar Extraction
- Keywords
- Quality of Life, Oral health, Prospective Studies, Molar, Third, Tooth Extraction, Patient Preference
- Medical subject headings
- Tooth, Impacted, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Session Bilateral Mandibular Third Molar ExtractionProcedure or surgery
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 ExtractionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-session arm | Active comparator | Not described Receives: Procedure: Single-Session Bilateral Mandibular Third Molar Extraction |
| Two-session arm | Active comparator | Not described Receives: Procedure: Two-Session Bilateral Mandibular Third Molar Extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, postoperative day 2, day 3, day 7, day 9, and day 14
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Mar 2018
- Primary completion1 Mar 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferit Bayram, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820867
- Sponsor's protocol ID
- MUDHF_FB_005
- Status last verified
- Apr 2023
- First submitted
- 25 Mar 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17666691Meng 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.
PubMed 32162995Long 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.
PubMed 32447777Holland 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.
PubMed 8818259Deepti 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.
PubMed 23139521Slade 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.
PubMed 9332805College 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.
PubMed 11132502Coulthard 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.
PubMed 25069437
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Single vs. Staged Extractions: OHRQoL Outcomes for Wisdom Teeth Removal
- ClinicalTrials.gov ID
- NCT05820867
- Acronym / sponsor ID
- MUDHF_FB_005
- Conditions
- Impacted Third Molar Tooth, Impacted Tooth
- Keywords
- Quality of Life, Oral health, Prospective Studies, Molar, Third, Tooth Extraction, Patient Preference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-Session Bilateral Mandibular Third Molar ExtractionParticipants 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. | Procedure or surgery | Single-session arm |
| Two-Session Bilateral Mandibular Third Molar ExtractionParticipants 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. | Procedure or surgery | Two-session arm |
Primary outcome
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.
2 secondary outcomes
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
Change in maximum interincisal opening
Time frame: Baseline and postoperative day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Background: PubMed 17666691Friedman 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.
- Background: PubMed 32162995Meng 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.
- Background: PubMed 32447777Long 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.
- Background: PubMed 8818259Holland 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.
- Background: PubMed 23139521Deepti 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.
- Background: PubMed 9332805Slade 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.
- Background: PubMed 11132502College 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.
- Background: PubMed 25069437Coulthard 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Session Bilateral Mandibular Third Molar Extraction and Two-Session Bilateral Mandibular Third Molar Extraction in people with Impacted Third Molar Tooth and Impacted Tooth, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05820867, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.