Impacted Third Molar ToothNCT05320744
the Relationship Between Various Clinical Variables and Surgical Difficulty of Patients Have Impacted Lower Third Molar
An observational study of Impacted Third Molar Tooth, run by University of Baghdad at 1 site in Iraq.
Trial summary
This study is to evaluate the effect of angle of impaction, impaction depth, and bone density on surgical difficulty of impacted lower third molar, by measuring the angle of impaction, the depth of impaction (Winter's Red line), and bone density (gonial, and antegonial indices) preoperatively by using panoramic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- surgical extraction of impacted lower third molar
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteIraq
- Study dates
- 3 Jan 2022to Feb 2023
- Phase
- Observational
- 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
Study population: This study will include a minimum of 50 patients indicated for surgical removal of impacted mandibular third molars at Baghdad college of dentistry.
Who may be able to join
- Healthy patients over 18 years old of either gender.
- Patients who have mesioangular or horizontal impacted mandibular third molar.
- Presence of mandibular second molar.
- Ability to tolerate surgical procedure.
- Exclusion Criteria:1. Patients with vertically and distoangularlly impacted teeth.
- 2. Patients with uncontrolled systemic diseases. 3. Patients with history of chemotherapy or radiotherapy therapy to the head and neck region.
- 4. Acute infection at the surgical site at time of operation. 5. The presence of cysts or tumors associated with the impacted teeth.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
university of Baghdad/ Baghdad college of dentistry
Baghdad
mohammed A muter, BDS, 07700661160, dentistiraq90@gmail.com
About this study
Official title: Evaluation the Effect of Angle of Impaction, Impaction Depth, and Bone Density on Surgical Difficulty of Impacted Mandibular Third Molar by Using Orthopantomography
This study is to evaluate the effect of angle of impaction, impaction depth, and bone density on surgical difficulty of impacted lower third molar, by measuring the angle of impaction, the depth of impaction (Winter's Red line), and bone density (gonial, and antegonial indices) preoperatively by using panoramic radiograph and to correlate the angle, the depth of impaction, and bone density with the surgical difficulty by operation time and surgical technique.
Read the detailed description
- All patients will provide detailed medical history and will sign a written informed consent. Oral hygiene instruction, scaling, and root planing.
- Panoramic radiograph will be taken for every patient, It will be used for measuring the angle of impaction along the lamina dura of the lower second and third molar and measuring impaction depth (Winter's Red line) by using software (planmeca romexis). The same software will be used to measure gonial index and antegonial angle as indices of bone density.
- All patients will have mouth rinsing with 0.2% chlorhexidine digluconate for 1 minute.
Surgical Procedure
- After administration of local anesthesia, full thickness enveloped or triangular flap incision according to the surgical principles.
- Flap reflection with periosteal elevator and retraction.
- Bone removal (if required) by using a slow speed, high torque surgical handpiece with sharp bur with copious normal saline irrigation.
- Tooth sectioning (if required) by using sharp diamond bur with saline irrigation.
- Tooth extraction by using appropriate elevator. .The operative difficulty will be determined by the surgical techniques of the extraction and the duration of extraction. With respect to the surgical technique the degree of difficulty is considered low when the extraction is performed by elevator alone, moderate when bone removal (ostectomy) is required, and high when ostectomy and tooth sectioning is required for tooth extraction.
For the duration of surgery, the difficulty is considered low when the duration of surgical extraction is less than 15 minutes, moderate when the duration is 15-30 minutes, and high when the duration is more than 30 minutes.
- Irrigation and cleaning of surgical site and removing remaining follicle if present.
- Bone smoothing with bone file and irrigation with saline.
- Flap Suturing with black silk suture 3/0.
- Ask the patient to bite on wet gauze.
- Instruction and medication (analgesic and antibiotic if required).
- Conditions
- Impacted Third Molar Tooth
- Being tested
- surgical extraction of impacted lower third molar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical extraction of impacted lower third molarProcedure or surgery
surgical removal of impacted third molar under local anesthesia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Angle of impaction
is measured along the lamina dura of lower second and third molar by using Planmeca Romexis Software.
Measured: preoperative
Winter Red line
is measured by drawing perpendicular line from amber line to the point of application of dental elevator by using Planmeca Romexis Software
Measured: preoperative
Gonial index
is measurement of mandibular cortical thickness by using bisectrix the gonial angle by using Planmeca Romexis Software
Measured: preoperative
Antegonial angle
is the measurement of the mandibular cortical thickness measured on the line perpendicular to the mandibular cortex at the intersection with the tangent line to the anterior border of the ramus by using Planmeca Romexis Software
Measured: preoperative
operative difficulty
determined by the surgical techniques of the extraction and the duration of extraction according to Pernambuco difficulty scale
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start3 Jan 2022
- Primary completionOct 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ahmed, University of Baghdad
- Investigators
- Salwan Y. Bede, F.I.B.M.S, Study chair, Baghdad college of dentistry/ Department of oral and maxillofacial surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320744
- Sponsor's protocol ID
- impacted lower third molar
- Status last verified
- Apr 2022
- First submitted
- 23 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all the results
Publications
de Carvalho RWF, Vasconcelos BC. Pernambuco index: predictability of the complexity of surgery for impacted lower third molars. Int J Oral Maxillofac Surg. 2018 Feb;47(2):234-240. doi: 10.1016/j.ijom.2017.07.013. Epub 2017 Aug 14.
PubMed 28818641Zhang X, Wang L, Gao Z, Li J, Shan Z. Development of a New Index to Assess the Difficulty Level of Surgical Removal of Impacted Mandibular Third Molars in an Asian Population. J Oral Maxillofac Surg. 2019 Jul;77(7):1358.e1-1358.e8. doi: 10.1016/j.joms.2019.03.005. Epub 2019 Mar 14.
PubMed 30959010
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effect of Angle of Impaction, Impaction Depth, and Bone Density on Surgical Difficulty of Impacted Mandibular Third Molar by Using Orthopantomography
- ClinicalTrials.gov ID
- NCT05320744
- Acronym / sponsor ID
- impacted lower third molar
- Conditions
- Impacted Third Molar Tooth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 11 Apr 2022 (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.
This study is to evaluate the effect of angle of impaction, impaction depth, and bone density on surgical difficulty of impacted lower third molar, by measuring the angle of impaction, the depth of impaction (Winter's Red line), and bone density (gonial, and antegonial indices) preoperatively by using panoramic radiograph and to correlate the angle, the depth of impaction, and bone density with the surgical difficulty by operation time and surgical technique.
Detailed description
- All patients will provide detailed medical history and will sign a written informed consent. Oral hygiene instruction, scaling, and root planing.
- Panoramic radiograph will be taken for every patient, It will be used for measuring the angle of impaction along the lamina dura of the lower second and third molar and measuring impaction depth (Winter's Red line) by using software (planmeca romexis). The same software will be used to measure gonial index and antegonial angle as indices of bone density.
- All patients will have mouth rinsing with 0.2% chlorhexidine digluconate for 1 minute.
Surgical Procedure
- After administration of local anesthesia, full thickness enveloped or triangular flap incision according to the surgical principles.
- Flap reflection with periosteal elevator and retraction.
- Bone removal (if required) by using a slow speed, high torque surgical handpiece with sharp bur with copious normal saline irrigation.
- Tooth sectioning (if required) by using sharp diamond bur with saline irrigation.
- Tooth extraction by using appropriate elevator. .The operative difficulty will be determined by the surgical techniques of the extraction and the duration of extraction. With respect to the surgical technique the degree of difficulty is considered low when the extraction is performed by elevator alone, moderate when bone removal (ostectomy) is required, and high when ostectomy and tooth sectioning is required for tooth extraction.
For the duration of surgery, the difficulty is considered low when the duration of surgical extraction is less than 15 minutes, moderate when the duration is 15-30 minutes, and high when the duration is more than 30 minutes.
- Irrigation and cleaning of surgical site and removing remaining follicle if present.
- Bone smoothing with bone file and irrigation with saline.
- Flap Suturing with black silk suture 3/0.
- Ask the patient to bite on wet gauze.
- Instruction and medication (analgesic and antibiotic if required).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include a minimum of 50 patients indicated for surgical removal of impacted mandibular third molars at Baghdad college of dentistry.
Key inclusion criteria (7 listed)
- Healthy patients over 18 years old of either gender.
- Patients who have mesioangular or horizontal impacted mandibular third molar.
- Presence of mandibular second molar.
- Ability to tolerate surgical procedure.
- Exclusion Criteria:1. Patients with vertically and distoangularlly impacted teeth.
Key exclusion criteria (0 listed)
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 extraction of impacted lower third molarsurgical removal of impacted third molar under local anesthesia. | Procedure or surgery | – |
Primary outcome
Angle of impaction
Time frame: preoperative
is measured along the lamina dura of lower second and third molar by using Planmeca Romexis Software.
Winter Red line
Time frame: preoperative
is measured by drawing perpendicular line from amber line to the point of application of dental elevator by using Planmeca Romexis Software
Gonial index
Time frame: preoperative
is measurement of mandibular cortical thickness by using bisectrix the gonial angle by using Planmeca Romexis Software
Antegonial angle
Time frame: preoperative
is the measurement of the mandibular cortical thickness measured on the line perpendicular to the mandibular cortex at the intersection with the tangent line to the anterior border of the ramus by using Planmeca Romexis Software
operative difficulty
Time frame: intraoperative
determined by the surgical techniques of the extraction and the duration of extraction according to Pernambuco difficulty scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Results publication: PubMed 28818641de Carvalho RWF, Vasconcelos BC. Pernambuco index: predictability of the complexity of surgery for impacted lower third molars. Int J Oral Maxillofac Surg. 2018 Feb;47(2):234-240. doi: 10.1016/j.ijom.2017.07.013. Epub 2017 Aug 14.
- Results publication: PubMed 30959010Zhang X, Wang L, Gao Z, Li J, Shan Z. Development of a New Index to Assess the Difficulty Level of Surgical Removal of Impacted Mandibular Third Molars in an Asian Population. J Oral Maxillofac Surg. 2019 Jul;77(7):1358.e1-1358.e8. doi: 10.1016/j.joms.2019.03.005. Epub 2019 Mar 14.
- Individual participant dataSharing planned: Yes. all the results
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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.
Salwan Y. Bede, F.I.B.M.S study chair
Baghdad college of dentistry/ Department of oral and maxillofacial surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impacted Third Molar Tooth, run by University of Baghdad at 1 site in Iraq.
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 7 inclusion and 0 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 11 Apr 2022. 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 Iraq. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed A. Muter, B.D.S. (07700661160, dentistiraq90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angle of impaction (time frame: preoperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05320744, which also lists 2 linked publications.
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 Apr 2022.