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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
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Impacted Third Molar Tooth

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age from 18 to 60 years with either gender
  2. Patients having impacted 3rd mandibular molar according to Winter's classification (as per operational definition)
  3. Patients with no evidence of dental caries or restoration in the past

Exclusion Criteria:

  1. Patients with history of orthodontic treatment or periodontal surgery
  2. Patients having craniofacial anomalies, congenital deformities or syndromes
  3. Patients with evidence of cyst or tumor in the molar area
  4. 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

    First Posted
    October 16, 2021
    Last Updated
    November 20, 2021
    Sponsor
    Dow University of Health Sciences
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    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

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    Accuracy of Variables for Impacted Mandibular Third Molar Surgery

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