Comparing OHRQoL: One or Two Sessions for Wisdom Teeth Removal

NCT ID: NCT05820867

Last Updated: 2023-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2021-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Impacted Third Molar Tooth Impacted Tooth

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Single-session arm

Group Type ACTIVE_COMPARATOR

Single-Session Bilateral Mandibular Third Molar Extraction

Intervention Type 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 arm

Group Type ACTIVE_COMPARATOR

Two-Session Bilateral Mandibular Third Molar Extraction

Intervention Type 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.

Interventions

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Single-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.

Intervention Type PROCEDURE

Two-Session Bilateral Mandibular Third Molar Extraction

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Ferit Bayram

Assist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Marmara University School of Dentistry

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 17666691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32162995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32447777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8818259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23139521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9332805 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11132502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25069437 (View on PubMed)

Other Identifiers

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MUDHF_FB_005

Identifier Type: -

Identifier Source: org_study_id

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