Impacted Third Molar ToothNCT05143359
Accuracy of Variables for Impacted Mandibular Third Molar Surgery
A study testing Wharfe and Pederson difficulty index and Winters difficulty index in people with Impacted Third Molar Tooth, run by Dow University of Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Wharfe and Pederson difficulty index and Winters difficulty index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Accuracy of Variables for Wharfe Assessment and Pederson Difficulty Index for Impacted Mandibular Third Molar Surgery
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.
Read the 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.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Wharfe and Pederson difficulty index, Winters difficulty index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wharfe and Pederson difficulty indexDiagnostic test
Efficiency of Wharfe and Pederson Difficulty index in extraction of third molars.
Winters difficulty indexDiagnostic test
Efficiency of Winters Difficulty index in extraction of third molars.
| Study group | Role | What they receive |
|---|---|---|
| Wharfe and Pederson difficulty index | Experimental | Assessment of Difficulty in third molar extraction using Wharfe and Pederson difficulty index Receives: Diagnostic Test: Wharfe and Pederson difficulty index |
| Winters difficulty index | Active comparator | Assessment of Difficulty in third molar extraction using Winters difficulty index Receives: Diagnostic Test: Winters difficulty index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extraction of mandibular 3rd molar
Difficulty of extraction will be assessed by difficulty index
Measured: Extraction of mandibular 3rd molar assessment by Wharfe and Peterson's index immediately after the intervention/procedure/surgery
Extraction of mandibular 3rd molar
Difficulty of extraction will be assessed by difficulty index
Measured: Extraction of mandibular 3rd molar assessment by winters immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start30 Nov 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gobind Ram, Dow University of Health Sciences
- Investigators
- Gobind Ram, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143359
- Sponsor's protocol ID
- GOBINDRAM
- Status last verified
- Nov 2021
- First submitted
- 16 Oct 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Variables for Wharfe Assessment and Pederson Difficulty Index for Impacted Mandibular Third Molar Surgery
- ClinicalTrials.gov ID
- NCT05143359
- Acronym / sponsor ID
- GOBINDRAM
- Conditions
- Impacted Third Molar Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 30 Nov 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wharfe and Pederson difficulty index | Experimental | Diagnostic Test: Wharfe and Pederson difficulty indexAssessment of Difficulty in third molar extraction using Wharfe and Pederson difficulty index |
| Winters difficulty index | Active comparator | Diagnostic Test: Winters difficulty indexAssessment of Difficulty in third molar extraction using Winters difficulty index |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wharfe and Pederson difficulty indexEfficiency of Wharfe and Pederson Difficulty index in extraction of third molars. | Diagnostic test | Wharfe and Pederson difficulty index |
| Winters difficulty indexEfficiency of Winters Difficulty index in extraction of third molars. | Diagnostic test | Winters difficulty index |
Primary outcome
Extraction of mandibular 3rd molar
Time frame: Extraction of mandibular 3rd molar assessment by Wharfe and Peterson's index immediately after the intervention/procedure/surgery
Difficulty of extraction will be assessed by difficulty index
Extraction of mandibular 3rd molar
Time frame: Extraction of mandibular 3rd molar assessment by winters immediately after the intervention/procedure/surgery
Difficulty of extraction will be assessed by difficulty index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gobind Ram principal investigator
Dow University of Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Wharfe and Pederson difficulty index and Winters difficulty index in people with Impacted Third Molar Tooth, run by Dow University of Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gobind Ram (+923331226622, rgobind2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extraction of mandibular 3rd molar (time frame: Extraction of mandibular 3rd molar assessment by Wharfe and Peterson's index immediately after the intervention/procedure/surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.