Impacted Third Molar Tooth Clinical Trial
Official title:
Prospective Comparison of Single vs. Staged Extractions: OHRQoL Outcomes for Wisdom Teeth Removal
Verified date | April 2023 |
Source | Marmara University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 59 |
Est. completion date | September 1, 2021 |
Est. primary completion date | March 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Turkey | Marmara University School of Dentistry | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Marmara University |
Turkey,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Postoperative 6th hour, 12th hour, day 2, day 3, day 7, day 9, and day 14 | |
Secondary | 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. | Baseline and postoperative day 7 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06023524 -
The Effectiveness of Laser Acupuncture and Standard Medication Therapy on Mandibular Post-Odontectomy Patients
|
N/A | |
Completed |
NCT02547896 -
Effectiveness of Diclofenac and Its Association to Codeine After Lower Third Molar Extraction.
|
Phase 4 | |
Completed |
NCT05684601 -
Impact of 3D Intraoral Scanning on Postsurgical Evaluation of Mandibular Third Molar Surgery
|
N/A | |
Completed |
NCT05170516 -
The Effect of Saline Irrigation at Different Temperatures on Pain, Edema, and Trismus After Impacted Third Molar Surgery
|
N/A | |
Completed |
NCT02481700 -
Epidemiological Study on the Surgical Removal of Third Molars
|
||
Completed |
NCT05488028 -
3D Evaluation of Facial Swelling Post Impacted Lower Third Molars Surgery: RCT
|
N/A | |
Completed |
NCT05679973 -
Evaluation of the Efficacy of Polybutester Suture on Postoperative Complications in Lower Impacted Third Molar Surgery
|
N/A | |
Recruiting |
NCT03741894 -
Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery
|
Phase 4 | |
Completed |
NCT06017570 -
Risk Factors for Distal Caries of Second Molars Adjacent to Mandibular Impacted Third Molars
|
N/A | |
Completed |
NCT03894722 -
Effects of Polyvinylpyrrolidone Iodine on Postoperative Trismus and Swelling During Impacted Third Molar Surgery
|
Phase 4 | |
Completed |
NCT02831374 -
Effectiveness of Platelet Rich Plasma in Wound Healing
|
Phase 0 | |
Completed |
NCT02837614 -
Evaluation of Preoperative Submucosal Dexamethasone in Third Molar Surgery
|
Phase 0 | |
Completed |
NCT02494856 -
Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in Lower Third Molar Removal
|
Phase 4 | |
Completed |
NCT02450487 -
Influence of Genotype of CYP2C9 on Clinical Efficacy and Pharmacokinetics of Piroxicam After Lower Third Molar Surgery
|
Phase 4 | |
Completed |
NCT05545553 -
Piezosurgery and Conventional Rotary Instruments on Third Molar Surgery
|
N/A | |
Recruiting |
NCT03619460 -
Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction
|
N/A | |
Not yet recruiting |
NCT05143359 -
Accuracy of Variables for Impacted Mandibular Third Molar Surgery
|
N/A | |
Completed |
NCT03784638 -
Comparison of Two Different Flap Designs for Bilateral Impacted Mandibular Third Molar Surgery
|
N/A | |
Completed |
NCT03752255 -
Verbal and Visual Information Techniques on Anxiety in Third Molar Surgery
|
N/A | |
Active, not recruiting |
NCT04349579 -
Evaluation of the Effects of Irrigation of the Extraction Socket With Rifamycine
|
Phase 4 |