Impacted Third Molar ToothNCT03447067
Computer Guided Versus Conventional Surgical Removal of Deeply Impacted Mandibular Third Molar With Preservation of External Oblique Ridge
A study testing computer guided surgical, Conventional surgery and CBCT in people with Impacted Third Molar Tooth, run by Alaadden Mahmoud Abu Al Enein.
Trial summary
in patent have deeply impacted lower third molar ,dose computer guided enhance surgical outcome versus conventional surgical remove of wisdom teeth Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- computer guided surgical, Conventional surgery and CBCT
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 28 Mar 2018to 30 Jul 2018
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient with deeply impacted mandibular third molar
- patients should be free from any systematic disease that affect normal healing
Who cannot join
- -Patient with soft tissue impaction and impaction class A position 1
- Medical problem that may interfere with the procedures such as bleeding disorder \& pregnant.
- Uncooperative patient.
Trial locations and contacts
No sites are listed yet.
About this study
in patent have deeply impacted lower third molar ,dose computer guided enhance surgical outcome versus conventional surgical remove of wisdom teeth
Read the detailed description
P- Patient with deeply impacted mandibular molar I- Computer guided surgical cutting stent C- Conventional extraction O- Clinical outcome sound radiographic outcomes primary outcome
- pain : each patient well be asked to rate current and worst pain intensity on visual analogue scale (VAS ) of 0-10 with Zero being no pain and Ten corresponds to the worst pain.
Secondary outcome
- evaluation of maximum inter incisal opening: assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisor by using tape graduated method.
- evaluation of edema throw use nylon thread.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- computer guided surgical, Conventional surgery, CBCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer guided surgicalProcedure or surgery
has three cutting guided plane for identify the position of place of the third molar, it have beveled cut for stability after remove the teeth and placing the bony window
Conventional surgeryProcedure or surgery
Low speed motor with surgiacl round burs and surgical fissure for removal a covering bone with decapitation and guttering formation
CBCTDevice
For measuring the bone removeal
CBCTDevice
for identifed the nerve
| Study group | Role | What they receive |
|---|---|---|
| Conventional surgery | Experimental | comprised 9 patient undergoing surgical removal of deeply impacted mandibular third molar by regular manor.
(Based on :Panorama and CBCT ) technique : 1- flap design 2- bone removal 3- tooth division 4- closure flap (suture) Receives: Procedure: computer guided surgical; Device: CBCT |
| computer guided surgery | Experimental | comprised 9 patient undergoing surgical removal of deeply impacted mandibular third molar using computer guided surgical cutting stent.
Based on (panorama , CBCT and fabricating computer guided stent technique: 1- flap design 2- accurate setting stent in a predesign site 3- bony window removing according to the stent design 4- surgical separation of the teeth with extraction the remaning part . 5- identify the nerve 6- replace the bony window in to original place with stability 7- closure and depridment Receives: Procedure: Conventional surgery; Device: CBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
each patient well be asked to rate current and worst pain intensity on visual analogue scale (VAS ) of 0-10 with Zero being no pain and Ten corresponds to the worst pain(pain change during follow up period .
Measured: immediate post operative ,at three day pain change till fourteen day day .
Secondary outcomes (1)
evaluation of maximum inter incisal opening
assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisor by using tape graduated method.
Measured: immediate post operative ,at three day inter incisal change till fourteen day .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start28 Mar 2018 (estimated)
- Primary completion1 Jul 2018 (estimated)
- Study completion30 Jul 2018 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaadden Mahmoud Abu Al Enein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaadden Mahmoud Abu Al Enein, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447067
- Sponsor's protocol ID
- 171986
- Status last verified
- Feb 2018
- First submitted
- 10 Feb 2018
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Guided Versus Conventional Surgical Removal of Deeply Impacted Mandibular Third Molar With Preservation of External Oblique Ridge
- ClinicalTrials.gov ID
- NCT03447067
- Acronym / sponsor ID
- 171986
- Conditions
- Impacted Third Molar Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Alaadden Mahmoud Abu Al EneinUniversity, hospital or other
- Study start
- 28 Mar 2018 (estimated)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 27 Feb 2018 (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.
in patent have deeply impacted lower third molar ,dose computer guided enhance surgical outcome versus conventional surgical remove of wisdom teeth
Detailed description
P- Patient with deeply impacted mandibular molar I- Computer guided surgical cutting stent C- Conventional extraction O- Clinical outcome sound radiographic outcomes primary outcome
- pain : each patient well be asked to rate current and worst pain intensity on visual analogue scale (VAS ) of 0-10 with Zero being no pain and Ten corresponds to the worst pain.
Secondary outcome
- evaluation of maximum inter incisal opening: assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisor by using tape graduated method.
- evaluation of edema throw use nylon thread.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional surgery | Experimental | Procedure: computer guided surgical, Device: CBCTcomprised 9 patient undergoing surgical removal of deeply impacted mandibular third molar by regular manor. (Based on :Panorama and CBCT ) technique : 1- flap design 2- bone removal 3- tooth division 4- closure flap (suture) |
| computer guided surgery | Experimental | Procedure: Conventional surgery, Device: CBCTcomprised 9 patient undergoing surgical removal of deeply impacted mandibular third molar using computer guided surgical cutting stent. Based on (panorama , CBCT and fabricating computer guided stent technique: 1- flap design 2- accurate setting stent in a predesign site 3- bony window removing according to the stent design 4- surgical separation of the teeth with extraction the remaning part . 5- identify the nerve 6- replace the bony window in to original place with stability 7- closure and depridment |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patient with deeply impacted mandibular third molar
- patients should be free from any systematic disease that affect normal healing
Key exclusion criteria (3 listed)
- -Patient with soft tissue impaction and impaction class A position 1
- Medical problem that may interfere with the procedures such as bleeding disorder \& pregnant.
- Uncooperative patient.
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 |
|---|---|---|
| computer guided surgicalhas three cutting guided plane for identify the position of place of the third molar, it have beveled cut for stability after remove the teeth and placing the bony window | Procedure or surgery | Conventional surgery |
| Conventional surgeryLow speed motor with surgiacl round burs and surgical fissure for removal a covering bone with decapitation and guttering formation | Procedure or surgery | computer guided surgery |
| CBCTFor measuring the bone removeal | Device | Conventional surgery |
| CBCTfor identifed the nerve | Device | computer guided surgery |
Primary outcome
Pain
Time frame: immediate post operative ,at three day pain change till fourteen day day .
each patient well be asked to rate current and worst pain intensity on visual analogue scale (VAS ) of 0-10 with Zero being no pain and Ten corresponds to the worst pain(pain change during follow up period .
1 secondary outcome
evaluation of maximum inter incisal opening
Time frame: immediate post operative ,at three day inter incisal change till fourteen day .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing computer guided surgical, Conventional surgery and CBCT in people with Impacted Third Molar Tooth, run by Alaadden Mahmoud Abu Al Enein.
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 2 inclusion and 3 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 27 Feb 2018. 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 alaaedein M abu al einain, master (00201011618208, surgeonalaamahmoud@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: immediate post operative ,at three day pain change till fourteen day day .). 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 27 Feb 2018.