Accuracy of Variables for Impacted Mandibular Third Molar Surgery
Primary Purpose
Impacted Third Molar Tooth
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wharfe and Pederson difficulty index
Winters difficulty index
Sponsored by
About this trial
This is an interventional prevention trial for Impacted Third Molar Tooth
Eligibility Criteria
Inclusion Criteria:
- Age from 18 to 60 years with either gender
- Patients having impacted 3rd mandibular molar according to Winter's classification (as per operational definition)
- Patients with no evidence of dental caries or restoration in the past
Exclusion Criteria:
- Patients with history of orthodontic treatment or periodontal surgery
- Patients having craniofacial anomalies, congenital deformities or syndromes
- Patients with evidence of cyst or tumor in the molar area
- Not willing to participate in my study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Wharfe and Pederson difficulty index
Winters difficulty index
Arm Description
Assessment of Difficulty in third molar extraction using Wharfe and Pederson difficulty index
Assessment of Difficulty in third molar extraction using Winters difficulty index
Outcomes
Primary Outcome Measures
Extraction of mandibular 3rd molar
Difficulty of extraction will be assessed by difficulty index
Extraction of mandibular 3rd molar
Difficulty of extraction will be assessed by difficulty index
Secondary Outcome Measures
Full Information
NCT ID
NCT05143359
First Posted
October 16, 2021
Last Updated
November 20, 2021
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05143359
Brief Title
Accuracy of Variables for Impacted Mandibular Third Molar Surgery
Official Title
Accuracy of Variables for Wharfe Assessment and Pederson Difficulty Index for Impacted Mandibular Third Molar Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 30, 2021 (Anticipated)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Accuracy of the variables used in Wharfe assessment and Pederson difficulty index for impacted mandibular third molar surgery.
The lower 3rd molar tooth is one of the most frequently impacted teeth. Its prevalence ranges from 30.3% to 68.6% worldwide according to a study conducted by Sekhar, 2020. The impaction of a tooth can be defined as a pathological condition in which eruption of tooth is not normal i.e. it is not erupted as expected within a specific time period. The impaction renders the affected tooth as non-functional due to its postural instability/ abnormal position. The normal tooth eruption is dependent on several local as well as systemic factors. Normal eruption can be altered by neighboring tooth, excessive soft tissue in the surrounding, or the dense overlying bone. Race and Ethnicity an also affect/ alter the impaction rate.
The removal of 3rd mandibular molar/ wisdom tooth is one of the most commonly performed surgical procedures, being done in dental clinics on daily basis. To predict the difficulty level of this procedure for impacted lower 3rd molar, no scoring system/ scale is considered sufficient i.e. every scale takes some factors into account, while missing some factors, so clinically not very much reliable. Some of the proposed scales/ models which are clinically in use are as follows: WHARFE's, Pederson's, Winter's, and Pell and Gregory's model.
Detailed Description
The lower 3rd molar tooth is one of the most frequently impacted teeth. Its prevalence ranges from 30.3% to 68.6% worldwide according to a study conducted by Sekhar, 2020.The impaction of a tooth can be defined as a pathological condition in which eruption of tooth is not normal i.e. it is not erupted as expected within a specific time period. The impaction renders the affected tooth as non-functional due to its postural instability/ abnormal position. The normal tooth eruption is dependent on several local as well as systemic factors. Normal eruption can be altered by neighboring tooth, excessive soft tissue in the surrounding, or the dense overlying bone. Race and Ethnicity an also affect/ alter the impaction rate.
The removal of 3rd mandibular molar/ wisdom tooth is one of the most commonly performed surgical procedures, being done in dental clinics on daily basis. To predict the difficulty level of this procedure for impacted lower 3rd molar, no scoring system/ scale is considered sufficient i.e. every scale takes some factors into account, while missing some factors, so clinically not very much reliable. Some of the proposed scales/ models which are clinically in use are as follows: WHARFE's, Pederson's, Winter's, and Pell and Gregory's model.
WHARFE's scoring system is a common classification/ system for the difficulty assessment while planning to remove a 3rd mandibular molar tooth. WHARFE stands for Winter's lines, Height of mandible, Angulation, Root, shape, & morphology, Follicular size, Exit pathway for tooth. This system helps to examine a tooth in more detail and its radiological status before planning any intervention to 3rd molar. While, Pederson's difficulty assessing scale is to predict the pre-operative and operative difficulty while riming the 3rd Mandibular Molar tooth that is impacted. It takes into account following variables: spatial relationship, depth, and ramus relationship. It is reported as slightly difficult (score 3-4), moderately difficult (score 5-6), and very difficult (score 7-10) with relation to the scores mentioned.
While doing research, I found that there is a handsome data available on different clinical scoring systems and their practical significance. But, I found the paucity of literature on the comparison of the variables used in Pederson's and WHARFE's scoring systems with practical procedures. So, this study was planned to assess the credibility of these variables. This study will also explore whether these systems are sufficient enough to rely upon, while (intelligently) planning intervention in the patients presenting with lower 3rd molar impaction. It will surely help to broaden the horizon of knowledge, followed by suggesting some guidelines to improve the clinical practice while treating these patients. The relevant data will be taken from participants and their relevant investigation results will be noted down in the pre-designed Performa (attached). This data will be interpreted in the SPSS version 23.0 (Statistical Package for the Social Sciences) program and will be followed by recommendations to improve the health care standards in Pakistan. This will ultimately update the knowledge and clinical approach of treating Oral & Maxillofacial Surgeons.
MATERIAL AND METHODS:
Study Design:
Observational Study Setting: The study will be conducted in the Oral & Maxillofacial Department on the patients visiting Dr Ishrat-ul-Ebad Khan Institute of Oral Health Sciences/ DUHS Karachi on outdoor basis or indoor basis.
Duration of Study:
Six months after the approval of synopsis.
Sample Size:
A total of 281 cases is calculated as sample size, from online calculator (from www.openepi.com) keeping confidence interval of 95% and the power of 80%, while taking the difficulty index as 24%, of molar teeth as 'very difficult' to operate, when Pederson scale index was applied. (Sekhar, M., Singh, S., & Valluri, R et al. Correlation of Variables for WHARFE Assessment and Pederson Difficulty Index for Impacted Mandibular Third Molar Surgery-A Prospective Clinical Study. Journal of Maxillofacial and Oral Surgery. 2020 July 25;1(1):1 -5. https://link.springer.com/article/10.1007%2Fs12663-020-01362-7)
Sampling Technique:
Purposive non-probability sampling technique would be used for the selection of patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wharfe and Pederson difficulty index
Arm Type
Experimental
Arm Description
Assessment of Difficulty in third molar extraction using Wharfe and Pederson difficulty index
Arm Title
Winters difficulty index
Arm Type
Active Comparator
Arm Description
Assessment of Difficulty in third molar extraction using Winters difficulty index
Intervention Type
Diagnostic Test
Intervention Name(s)
Wharfe and Pederson difficulty index
Intervention Description
Efficiency of Wharfe and Pederson Difficulty index in extraction of third molars.
Intervention Type
Diagnostic Test
Intervention Name(s)
Winters difficulty index
Intervention Description
Efficiency of Winters Difficulty index in extraction of third molars.
Primary Outcome Measure Information:
Title
Extraction of mandibular 3rd molar
Description
Difficulty of extraction will be assessed by difficulty index
Time Frame
Extraction of mandibular 3rd molar assessment by Wharfe and Peterson's index immediately after the intervention/procedure/surgery
Title
Extraction of mandibular 3rd molar
Description
Difficulty of extraction will be assessed by difficulty index
Time Frame
Extraction of mandibular 3rd molar assessment by winters immediately after the intervention/procedure/surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age from 18 to 60 years with either gender
Patients having impacted 3rd mandibular molar according to Winter's classification (as per operational definition)
Patients with no evidence of dental caries or restoration in the past
Exclusion Criteria:
Patients with history of orthodontic treatment or periodontal surgery
Patients having craniofacial anomalies, congenital deformities or syndromes
Patients with evidence of cyst or tumor in the molar area
Not willing to participate in my study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gobind Ram
Phone
+923331226622
Email
rgobind2@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gobind Ram
Phone
+923331226644
Email
rgobind2@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gobind Ram
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Accuracy of Variables for Impacted Mandibular Third Molar Surgery
We'll reach out to this number within 24 hrs