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Not yet recruitingNCT06044766Updated Sep 21, 2023

Verification of the Root Form Classification of Impacted Lower Third Molars

An interventional study of Surgical exatrction of impacted lower third molars in Impacted Lower Third Molars Roots, sponsored by Riyadh Colleges of Dentistry and Pharmacy. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Riyadh Colleges of Dentistry and Pharmacy · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Impacted Lower Third Molars Roots

Keywords

  • impacted lower third olars
  • Roots morphology
  • Root forms
03

In context

Lead sponsor

Riyadh Colleges of Dentistry and Pharmacy is the lead sponsor of 28 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

incomplete apex formation and root resorption

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Surgical exatrction of impacted lower third molars

    Clinical intervention: Surgical exatrction of impacted lower third molar to examine and classify the roots, then to compare it with radiographic classification

    Procedure: Surgical exatrction of impacted lower third molars

Interventions

  • ProcedureSurgical exatrction of impacted lower third molars

    Surgical exatrction of impacted lower third molars to verify the form of the root

06

What researchers measure

Primary outcomes

  1. Frequency of discrepancies and agreements on the classified root forms

    To report the radiographic classifications of root forms by two examiners

    Time frame: Before surgical exatration

  2. Frequency of discrepancies and agreements on the classified root forms

    To report the clinical classifications of root forms

    Time frame: Immidiately after extraction

Secondary outcomes

  1. The frequency of root types

    The frequency of fused roots and separated roots

    Time frame: Immediately after extraction

  2. The frquency of fused root forms

    The frequency of the four fused roots forms

    Time frame: Immediately after extraction

  3. The frequency of separated root forms

    The frequency of the six separated root forms

    Time frame: Immediately after extraction

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — After publication

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06044766
Lead sponsor
Riyadh Colleges of Dentistry and Pharmacy
Responsible party
Nedal Abu-Mostafa (Assistant Professor in Oral and Maxillofacial Surgery, Riyadh Colleges of Dentistry and Pharmacy) — Principal investigator
First posted
Sep 21, 2023
Start date
Oct 1, 2023 (estimated)
Primary completion
Jul 31, 2024 (estimated)
Completion
Aug 15, 2024 (estimated)
Last update
Sep 21, 2023

Study contacts

Nedal A Abu-Mostafa, Assistant Professor
Contact
nabumostafa@gmail.com
+966506275782

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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