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

• Sponsor: Selcuk University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05049382
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 4
• Actual Duration (Months): 4.5
• Patients Per Site Per Month: 66.2

Study Details

Study Description

Brief Summary

The tooth of the patient who applies to the clinic for the impacted wisdom tooth will be classified according to pell-gregory and winter. Before the extraction, patients' interincisal, tragus-commissura and lateral canthus-angulus distances, Oral Health Impact Profile -14 (OHIP-14) scores will be measured.

Operation time will be recorded. After the operation, on 3rd day patients' interincisal, tragus-commissura and lateral canthus-angulus distances, OHIP-14 scores and Visual Analogue Scale scores will be recorded. On 7th and 14th day, all these measurement will be replied. On 30th day and 60th day OHIP-14 scores will measured again.

All these data will be evaluated to find any correlation between; operation time, classification and post-op outcomes.

Condition or Disease	Intervention/Treatment	Phase
Impacted Third Molar Tooth	Procedure: Extraction of impacted mandibular third molar	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: All measurements will be made by a researcher who does not know whether it is a preop or postop measurement, which tooth will be extracted, and the classification of the tooth.
• Primary Purpose: Treatment
• Official Title: Does Extraction Difficulty of Mandibular Impacted Third Molars Mirror Post-op Outcomes?
• Actual Study Start Date: Sep 9, 2021
• Actual Primary Completion Date: Jan 15, 2022
• Actual Study Completion Date: Jan 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mesioangular Classified as mesioangular according to winter classification	Procedure: Extraction of impacted mandibular third molar; surgical extraction of impacted mandibular third molar tooth
Experimental: Vertical Classified as vertical according to winter classification	Procedure: Extraction of impacted mandibular third molar; surgical extraction of impacted mandibular third molar tooth
Experimental: Distoangular Classified as distoangular according to winter classification	Procedure: Extraction of impacted mandibular third molar; surgical extraction of impacted mandibular third molar tooth
Experimental: Horizontal Classified as horizontal according to winter classification	Procedure: Extraction of impacted mandibular third molar; surgical extraction of impacted mandibular third molar tooth

Outcome Measures

Primary Outcome Measures

1. interincisal distance [0th day]

   the distance between right upper central incisor incisal line and right upper incisor incisal line

2. tragus-commissura distance [0th day]

   the distance between tragus and angulus in relevant side

3. lateral canthus-angulus distance [0th day]

   the distance between lateral canthus and angulus in relevant side

4. OHIP-14 score [0th day]

   Oral Health Impact Profile Score(14-70; higher is worse)

5. VAS score [3rd day]

   Visual analog scale score(0-10; higher is worse)

6. Operation time [During the operation]

   Duration of surgical intervention

Secondary Outcome Measures

1. interincisal distance [3rd and 10th day]

   the distance between right upper central incisor incisal line and right upper incisor incisal line

2. tragus-commissura distance [3rd and 10th day]

   the distance between tragus and angulus in relevant side

3. lateral canthus-angulus distance [3rd and 10th day]

   the distance between lateral canthus and angulus in relevant side

4. VAS score [10th day]

   Visual analog scale score(0-10; higher is worse)

5. OHIP -14 score [3rd, 10th, 30th and 60th day]

   Oral Health Impact Profile Score(14-70; higher is worse)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Having extraction of only mandibular third molar No systemic disease Signing informed consent Participate all follow up control appointments

Exclusion Criteria:

Infection at surgery zone Alveolar osteitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Selcuk University, Dentistry Faculty	Selçuklu	Konya	Turkey	42250

Sponsors and Collaborators

• Selcuk University

Investigators

• Study Chair: Gökhan Gürses, Selcuk Universty/Dentistry Faculty
• Principal Investigator: Adil Ersoy, Selcuk Universty/Dentistry Faculty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gokhan Gurses, Assistant Professor, Selcuk University
• ClinicalTrials.gov Identifier: NCT05049382
• Other Study ID Numbers: SelcukU01
• First Posted: Sep 20, 2021
• Last Update Posted: Jan 26, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tooth, Impacted

Study Results

No Results Posted as of Jan 26, 2022