Impacted Lower Third Molars RootsNCT06044766
Verification of the Root Form Classification of Impacted Lower Third Molars
A study testing Surgical exatrction of impacted lower third molars in people with Impacted Lower Third Molars Roots, run by Riyadh Colleges of Dentistry and Pharmacy.
Trial summary
A clinical study will be conducted to verify the reliability of the root form classification of impacted lower third molars that was put by Abu-Mostafa N (2023) The root forms of partially or fully impacted lower third molars will be classified pre-operatively based on panoramic radiograph, then clinically after… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impacted Lower Third Molars Roots
- What is being tested?
- Surgical exatrction of impacted lower third molars
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 15 Aug 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with impacted lower third molars who visit Riyadh Elm University" hospital and have lower third molars which are diagnosed clinically and radiographically as partially or fully impacted. The roots of these third molars have to be fully formed.
Who cannot join
- incomplete apex formation and root resorption
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Clinical Study to Verify the Reliability of Root Form Classification of Impacted Lower Third Molars
A clinical study will be conducted to verify the reliability of the root form classification of impacted lower third molars that was put by Abu-Mostafa N (2023) The root forms of partially or fully impacted lower third molars will be classified pre-operatively based on panoramic radiograph, then clinically after extraction, and the identified root classifications will be compared.
Read the detailed description
According to Abu-Mostafa N, the roots of impacted lower third molars are classified into two types: Fused roots and separated roots. Both have different forms:
Fused roots forms: Straight, Curved distal, Curved mesial, and S-shaped.
Separated roots forms: Straight, Both roots are curved distal, Both roots are curved mesial, Joined roots, One root is straight and one is curved, and More than two roots.
A panoramic radiograph will be taken before extraction, then the roots will be classified by two Oral biologist and Oral and Maxillofacial Surgeon individually. After surgical extraction of the third molar, the roots will be examined clinically and classified according to the same classification.
The two pre-extraction radiographic classifications will be compared together, and then they will be compared with the clinical classification to check if there is a discrepancy.
The surgical extraction procedure:
Local anesthesia will be achieved by inferior alveolar nerve block and buccal infiltration using Lidocaine 2% with Epinephrine 1:100,000. A flap with a distobuccal releasing incision will be done. The bone reduction will be performed by a low-speed surgical handpiece under irrigation with normal saline. Root separation is done of required for the third molars with separated root forms. The tooth will be luxated by straight elevators and then extracted.
The evaluation results will be categorized to:
- Agreement: The two pre-extraction radiographic evaluations and the clinical evaluations are similar
- Discrepancy 1: One pre-extraction radiographic evaluation and the clinical evaluations are similar, but the other radiographic evaluation differs.
- Discrepancy 2: the two pre-extraction radiographic evaluations are similar, but the clinical evaluation differs.
- Disagreement: The three evaluations are different
The results will be analyzed regarding frequencies and association of each category with root forms
- Conditions
- Impacted Lower Third Molars Roots
- Being tested
- Surgical exatrction of impacted lower third molars
- Keywords
- impacted lower third olars, Roots morphology, Root forms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical exatrction of impacted lower third molarsProcedure or surgery
Surgical exatrction of impacted lower third molars to verify the form of the root
| Study group | Role | What they receive |
|---|---|---|
| Surgical exatrction of impacted lower third molars | Other | Clinical intervention: Surgical exatrction of impacted lower third molar to examine and classify the roots, then to compare it with radiographic classification Receives: Procedure: Surgical exatrction of impacted lower third molars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of discrepancies and agreements on the classified root forms
To report the radiographic classifications of root forms by two examiners
Measured: Before surgical exatration
Frequency of discrepancies and agreements on the classified root forms
To report the clinical classifications of root forms
Measured: Immidiately after extraction
Secondary outcomes (3)
The frequency of root types
The frequency of fused roots and separated roots
Measured: Immediately after extraction
The frquency of fused root forms
The frequency of the four fused roots forms
Measured: Immediately after extraction
The frequency of separated root forms
The frequency of the six separated root forms
Measured: Immediately after extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Lower Third Molars RootsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nedal Abu-Mostafa, Riyadh Colleges of Dentistry and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044766
- Sponsor's protocol ID
- REU2
- Status last verified
- Sep 2023
- First submitted
- 11 May 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Verify the Reliability of Root Form Classification of Impacted Lower Third Molars
- ClinicalTrials.gov ID
- NCT06044766
- Acronym / sponsor ID
- REU2
- Conditions
- Impacted Lower Third Molars Roots
- Keywords
- impacted lower third olars, Roots morphology, Root forms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 21 Sep 2023 (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.
A clinical study will be conducted to verify the reliability of the root form classification of impacted lower third molars that was put by Abu-Mostafa N (2023) The root forms of partially or fully impacted lower third molars will be classified pre-operatively based on panoramic radiograph, then clinically after extraction, and the identified root classifications will be compared.
Detailed description
According to Abu-Mostafa N, the roots of impacted lower third molars are classified into two types: Fused roots and separated roots. Both have different forms:
Fused roots forms: Straight, Curved distal, Curved mesial, and S-shaped.
Separated roots forms: Straight, Both roots are curved distal, Both roots are curved mesial, Joined roots, One root is straight and one is curved, and More than two roots.
A panoramic radiograph will be taken before extraction, then the roots will be classified by two Oral biologist and Oral and Maxillofacial Surgeon individually. After surgical extraction of the third molar, the roots will be examined clinically and classified according to the same classification.
The two pre-extraction radiographic classifications will be compared together, and then they will be compared with the clinical classification to check if there is a discrepancy.
The surgical extraction procedure:
Local anesthesia will be achieved by inferior alveolar nerve block and buccal infiltration using Lidocaine 2% with Epinephrine 1:100,000. A flap with a distobuccal releasing incision will be done. The bone reduction will be performed by a low-speed surgical handpiece under irrigation with normal saline. Root separation is done of required for the third molars with separated root forms. The tooth will be luxated by straight elevators and then extracted.
The evaluation results will be categorized to:
- Agreement: The two pre-extraction radiographic evaluations and the clinical evaluations are similar
- Discrepancy 1: One pre-extraction radiographic evaluation and the clinical evaluations are similar, but the other radiographic evaluation differs.
- Discrepancy 2: the two pre-extraction radiographic evaluations are similar, but the clinical evaluation differs.
- Disagreement: The three evaluations are different
The results will be analyzed regarding frequencies and association of each category with root forms
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical exatrction of impacted lower third molars | Other | Procedure: Surgical exatrction of impacted lower third molarsClinical intervention: Surgical exatrction of impacted lower third molar to examine and classify the roots, then to compare it with radiographic classification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with impacted lower third molars who visit Riyadh Elm University" hospital and have lower third molars which are diagnosed clinically and radiographically as partially or fully impacted. The roots of these third molars have to be fully formed.
Key exclusion criteria (1 listed)
- incomplete apex formation and root resorption
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 |
|---|---|---|
| Surgical exatrction of impacted lower third molarsSurgical exatrction of impacted lower third molars to verify the form of the root | Procedure or surgery | Surgical exatrction of impacted lower third molars |
Primary outcome
Frequency of discrepancies and agreements on the classified root forms
Time frame: Before surgical exatration
To report the radiographic classifications of root forms by two examiners
Frequency of discrepancies and agreements on the classified root forms
Time frame: Immidiately after extraction
To report the clinical classifications of root forms
3 secondary outcomes
The frequency of root types
Time frame: Immediately after extraction
The frquency of fused root forms
Time frame: Immediately after extraction
The frequency of separated root forms
Time frame: Immediately after extraction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No. After publication
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.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical exatrction of impacted lower third molars in people with Impacted Lower Third Molars Roots, run by Riyadh Colleges of Dentistry and Pharmacy.
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 1 inclusion and 1 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 21 Sep 2023. 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 Nedal A Abu-Mostafa, Assistant Professor (+966506275782, nabumostafa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of discrepancies and agreements on the classified root forms (time frame: Before surgical exatration). 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 21 Sep 2023.