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Tooth DisplacementNCT06060522

Retrieval of Displaced Mandibular Third Molar Teeth

A study testing CT, CBCT in people with Tooth Displacement, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to compare multi-detector CT and CBCT as pre-surgical diagnostic imaging before surgical retrieval of iatrogenic displaced mandibular third molar teeth/roots. Read more about this study

Who is it for?
Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Tooth Displacement
What is being tested?
CT, CBCT
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteEgypt
Study dates
25 Oct 2022to 2 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 20 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients had a challenging and unsuccessful extraction of an impacted mandibular third molar by a general dentist under local anesthesia.

Who cannot join

  • Patients presented with pathologic lesions (dental cyst or tumor) around the tooth to be retrieved

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Tanta University

    Tanta, Gharbia Governorate, 3111

Other trials in Egypt

About this study

Official title: Multi-detector Computed Tomography Versus Cone Beam Computed Tomography as a Diagnostic Imaging in Retrieval of Displaced Mandibular Third Molar Teeth/Roots

The aim of this study is to compare multi-detector CT and CBCT as pre-surgical diagnostic imaging before surgical retrieval of iatrogenic displaced mandibular third molar teeth/roots.

Read the detailed description

Sixteen patients will included in this study that they had previously a challenging and unsuccessful extraction of an impacted mandibular third molar by a general dentist under local anesthesia.

Groups allocation:

For detailed radiographic examination, when a displaced tooth/root fragment is suspected the patients will randomly divided into two equal groups, each of eight patients:

Group (1): Multi-detector computed tomography (MDCT ) are performed using CT scanner (SOMATOM Emotion6, Siemens, Germany). The protocol is 200 mAs, 120 kVp, 512 × 512 matrix, 1.172 pitch, 64 × 0.625 mm section collimation, 2 mm slice thickness, 0.6 mm section reconstruction Group (II): CBCT** scans are performed with an exposure performed at 15 mA, 85 KV and at a field of view 7.5 cm x 14.5 cm x 14.5 cm.

Image reconstruction All images will be reconstructed at 0.6 mm and the reconstructed axial images are transferred to a workstation, and multi-planar reconstructions are generated using the included standard dental software package. The panoramic and paraxial images were obtained perpendicular to the transverse images. Then multi-planar reformation (MPR), maximum intensity projection (MIP) and shaded surface display (SSD) are done in different planes.

Image interpretation (analysis):

Axial and reformatted images are evaluated to detected the position of displaced third molar tooth or root in relation to the mandible and the mylohyoid muscle.

Preoperative instruction It will intended for all patients to have their displaced tooth or root fragments retrieved using an intra-oral approach while being under general anesthesia following standard blood tests and pre-anesthetic examinations.

Surgical procedure All surgeries are performed in a standardized fashion, using the same surgical and pharmacological protocols. All surgeons had at least 5 years of experience in third molar teeth extraction. Before surgery, the patient performed a mouth rinse of chlorhexidine 0.12% for one minute. Dexamethasone 8 mg is given orally to the patient one hour before surgery to promote the best possible postoperative results.

Under general anesthesia, a lingual envelope incision is performed to access and remove the displaced third molar tooth or root, and a mucoperiosteal flap was released from the retromolar trigone to the medial surface of the mandibular first premolar. By carefully retracting the lingual soft tissue, an envelope flap was raised on the lingual side from the second premolar to the anterior boundary of the ramus. This protected the lingual nerve from injury. With great caution, the lingual flap is reflected up to the submandibular area so that the tooth or root fragment will be identified. An extra-oral finger is used as support. (Jo Through blunt dissection, the loose tooth or root is located, grabbed using a pair of artery forceps, and extracted. The flaps are sutured using 3-0 Vicryl sutures after the wound was irrigated with normal saline.

Post-operative evaluation At the conclusion of the intervention, the same operators meticulously filled out a data collection form for each patient. These documents are momentarily kept in a secure location inside the operational unit. A progressive numerical code is given to each patient as a means of identification. Gender, birthdate, the anatomical location of the misplaced tooth or root, and the duration of the operation (calculated from the incision to socket cleaning) are all collected.

On the seventh post-operative day, the sutures are removed, and the patients are evaluated for the following: Pain , swelling ,Trismus and Sensory disturbances

Being tested
CT, CBCT
Keywords
Displaced wisdom, Computed Tomography, Cone beam Computed Tomography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT, CBCTDiagnostic test

    Also called Surgery

    Under general anesthesia, a lingual envelope incision is performed to access and remove the displaced third molar tooth or root, and a mucoperiosteal flap is released from the retromolar trigone to the medial surface of the mandibular first premolar. By carefully retracting the lingual soft tissue, an envelope flap is raised on the lingual side from the second premolar to the anterior boundary of the ramus. This protected the lingual nerve from injury. With great caution, the lingual flap is reflected up to the submandibular area so that the tooth or root fragment will be identified. An extra-oral finger is used as support.Through blunt dissection, the loose tooth or root is located, grabbed using a pair of artery forceps, and extracted.

    The flaps are sutured using 3-0 Vicryl sutures after the wound is irrigated with normal saline.

Study groups in NCT06060522
Study groupRoleWhat they receive
Multi-detector computed tomography (MDCT )Active comparatorMulti-detector computed tomography (MDCT ) will be performed for 8 patients performed using CT scanner (SOMATOM Emotion6, Siemens, Germany). The protocol was 200 mAs, 120 kVp, 512 × 512 matrix, 1.172 pitch, 64 × 0.625 mm section collimation, 2 mm slice thickness, 0.6 mm section reconstruction
Receives: Diagnostic Test: CT, CBCT
CBCT scansActive comparatorCBCT will be performed for 8 patients with an exposure performed at 15 mA, 85 KV and at a field of view 7.5 cm x 14.5 cm x 14.5 cm.
Receives: Diagnostic Test: CT, CBCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. degree of Pain

    The degree of pain is determined during the follow-up periods according to the visual analogue pain scale (VAS) from 0 (no pain at all) to 10 (most severe pain)

    Measured: 3 months

  2. Swelling

    assessed utilizing a vertical and horizontal guide with a tape on four reference points; outer canthus of the eye, angle of the mandible, tragus, and outer corner of the mouth respectively

    Measured: 3 months

  3. Sensory disturbances

    Nerve dysesthesia is recorded using two-point discrimination test

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2023
  2. Study start25 Oct 2022
  3. Primary completion10 Apr 2023
  4. Study completion2 Aug 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06060522
Sponsor's protocol ID
M22011122
Status last verified
Feb 2025
First submitted
23 Sep 2023
Last updated
11 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CT, CBCT in people with Tooth Displacement, run by Tanta University at 1 site in Egypt.

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: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

degree of Pain (time frame: 3 months). The study lists 3 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 11 Feb 2025.

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