Does Extraction Difficulty of Mandibular Impacted Third Molars Mirror Post-op Outcomes?

Impacted Third Molar Tooth Clinical Trial

Official title:

Does Extraction Difficulty of Mandibular Impacted Third Molars Mirror Post-op Outcomes?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05049382
• Other study ID #: SelcukU01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 9, 2024
• Est. completion date: August 25, 2024

Study information

• Verified date: March 2024
• Source: Selcuk University
• Contact: Gökhan Gürses
• Phone: 5052595359
• Email: gokhan0gurses[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The tooth of the patient who applies to the clinic for the impacted wisdom tooth will be classified according to Escoda's difficulty classification. Before the extraction, patients' interincisal, tragus-commissural, and lateral canthus-angulus distances, Oral Health Impact Profile -14 (OHIP-14) scores, and serum levels of CRP and D-Dimer will be measured. Operation time will be recorded. After the operation, on 4th-day patients' patients' interincisal, tragus-commissural, and lateral canthus-angulus distances, Oral Health Impact Profile -14 (OHIP-14) scores, and serum levels of CRP and D-Dimer and Visual Analogue Scale (for pain) scores will be measured and recorded. On the 10th day, all these measurements will be repeated. All recorded data will be evaluated for possible correlations based on extraction difficulties.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 159
• Est. completion date: August 25, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Having extraction of only the mandibular third molar
• No systemic disease
• Signing an informed consent
• No dental phobia or anxiety
• No lesion around the impacted tooth
• Presence of adjacent second molar

Exclusion Criteria:

• Infection after surgery
• Alveolar osteitis
• Not to participate in any follow-up control appointments

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Tooth, Impacted

Intervention

Procedure:
• Extraction of impacted mandibular third molar
surgical extraction of impacted mandibular third molar tooth

Locations

Country	Name	City	State
Turkey	Selcuk University, Dentistry Faculty	Selçuklu	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	interincisal distance change	The distance between the right upper central incisor incisal line and the right upper incisor incisal line will be measured before the surgery, on the 5th and 10th day. The changes will be evaluated.	before the surgery, 4th and 10th days
Primary	tragus-commissura distance	the distance between tragus and angulus in relevant side will be measured before the surgery, on the 5th and 10th day. The changes will be evaluated.	before the surgery, 4th and 10th days
Primary	lateral canthus-angulus distance	the distance between lateral canthus and angulus in relevant side will be measured before the surgery, on the 5th and 10th day. The changes will be evaluated.	before the surgery, 4th and 10th days
Primary	OHIP-14 score	Oral Health Impact Profile Score(14-70; higher is worse)	before the surgery, 4th and 10th days
Primary	VAS score	Visual analog scale score(0-10; higher is worse)	4th and 10th days
Primary	Operation time	Duration of surgical intervention	after the operation
Primary	CRP serum level	Serum levels of CRP will be measured via blood samples before the surgery and the 5th day.	before the surgery and 4th day
Primary	D-Dimer serum level	Serum levels of D-Dimer will be measured via blood samples before the surgery and the 5th day.	before the surgery and 4th day