Missing TeethNCT04153851
Study the Effect of Neurectomy of Nasopalatine Nerve on Sensation of Anterior Palate
A study testing neurectomy of nasopalatine nerve in people with Missing Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
Study the effect of neurectomy of nasopalatine nerve on the sensation of anterior palate in patients undergoing rehabilitation of anterior maxillary ridge with dental implant Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- neurectomy of nasopalatine nerve
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 31 Dec 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • Adult patients requiring dental implants placement in the anterior region of maxilla and has insufficient horizontal bone .
- Patients should be free from any systemic conditions that may affect soft tissue healing.
Who cannot join
- • Patients with systematic disease that may complicate healing.
- Uncontrolled diabetic patient.
- Patients with advanced osteoporosis.
- Patients under bisphosphonates treatment.
- Patients with neurological disorders (neuralgias, Parkinson's disease).
- Patients with horizontal ridge atrophy (if the horizontal dimension of the residual ridge <3mm as determined with ridge callipers).
- Heavy smoker patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Cairo
Abdelmoez Elsharkawy, lecturer
About this study
Official title: Effect of Neurectomy of Nasopalatine Nerve on Sensation of Anterior Palate in Patient Undergoing Rehabilitation of Atrophic Anterior Maxillary Ridge With Dental Implant
Study the effect of neurectomy of nasopalatine nerve on the sensation of anterior palate in patients undergoing rehabilitation of anterior maxillary ridge with dental implant
Read the detailed description
Replacement of missing teeth in the anterior maxilla could be challenging if enlargement of the nasopalatine canal which is located in the midline of the palate posterior to the maxillary central incisors or ridge atrophy occur after tooth extraction. This could place the neurovascular content of the nasopaltine canal in the path of the dental implant which may lead to complications such as nasopalatine canal cyst, sensory dysfunction or implant failure. Technique to overcome this problem have evolved including neurectomy of the nasopalatine canal content and obliteration of canal with bone graft.
Loss of sensation in anterior palate following this procedure could be an annoying complication for patients. In recent studies regaining of sensation following such procedure have been reported, Confirmation of such results is essential to rule out the side effect of loss of sensation in the anterior palatal region
- Conditions
- Missing Teeth
- Being tested
- neurectomy of nasopalatine nerve
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurectomy of nasopalatine nerveProcedure or surgery
Severing of nerurovascular bundle and pushing the nasopalatine canal content nasally and insertion of bone graft in the canal. Dental implant will be inserted in the central incisor location
| Study group | Role | What they receive |
|---|---|---|
| neurectomy of nasopalatine nerve | Other | 1. Prophylactic preoperative antibiotic will be administered prior to surgery.
2. Oral disinfection will be performed before surgery.
3. Labial infiltration anesthesia and nasopalatine nerve block anasthesia.
4. The nasopalatine foramen will be exposed after reflection of a palatal and buccal flap.
5. Severing of nerurovascular bundle and pushing the nasopalatine canal content nasally and insertion of bone graft in the canal.
6. Dental implant will be inserted in the central incisor location. Receives: Procedure: neurectomy of nasopalatine nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
two point discrimination test
This test will be performed using a calliper, the two points of the calliper are opened progressively in 1mm increments and care should be taken that the two points are touching the mucosa in the same time until the patient can discriminate two points of contact at which the distance between the two points is recorded
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing TeethStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed hamdi morsi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153851
- Sponsor's protocol ID
- OMFS 6-3-1
- Status last verified
- Nov 2019
- First submitted
- 2 Nov 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neurectomy of Nasopalatine Nerve on Sensation of Anterior Palate in Patient Undergoing Rehabilitation of Atrophic Anterior Maxillary Ridge With Dental Implant
- ClinicalTrials.gov ID
- NCT04153851
- Acronym / sponsor ID
- OMFS 6-3-1
- Conditions
- Missing Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 Nov 2019 (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.
Study the effect of neurectomy of nasopalatine nerve on the sensation of anterior palate in patients undergoing rehabilitation of anterior maxillary ridge with dental implant
Detailed description
Replacement of missing teeth in the anterior maxilla could be challenging if enlargement of the nasopalatine canal which is located in the midline of the palate posterior to the maxillary central incisors or ridge atrophy occur after tooth extraction. This could place the neurovascular content of the nasopaltine canal in the path of the dental implant which may lead to complications such as nasopalatine canal cyst, sensory dysfunction or implant failure. Technique to overcome this problem have evolved including neurectomy of the nasopalatine canal content and obliteration of canal with bone graft.
Loss of sensation in anterior palate following this procedure could be an annoying complication for patients. In recent studies regaining of sensation following such procedure have been reported, Confirmation of such results is essential to rule out the side effect of loss of sensation in the anterior palatal region
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neurectomy of nasopalatine nerve | Other | Procedure: neurectomy of nasopalatine nerve1. Prophylactic preoperative antibiotic will be administered prior to surgery. 2. Oral disinfection will be performed before surgery. 3. Labial infiltration anesthesia and nasopalatine nerve block anasthesia. 4. The nasopalatine foramen will be exposed after reflection of a palatal and buccal flap. 5. Severing of nerurovascular bundle and pushing the nasopalatine canal content nasally and insertion of bone graft in the canal. 6. Dental implant will be inserted in the central incisor location. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- • Adult patients requiring dental implants placement in the anterior region of maxilla and has insufficient horizontal bone .
Key exclusion criteria (7 listed)
- • Patients with systematic disease that may complicate healing.
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 |
|---|---|---|
| neurectomy of nasopalatine nerveSevering of nerurovascular bundle and pushing the nasopalatine canal content nasally and insertion of bone graft in the canal. Dental implant will be inserted in the central incisor location | Procedure or surgery | neurectomy of nasopalatine nerve |
Primary outcome
two point discrimination test
Time frame: six months
This test will be performed using a calliper, the two points of the calliper are opened progressively in 1mm increments and care should be taken that the two points are touching the mucosa in the same time until the patient can discriminate two points of contact at which the distance between the two points is recorded
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurectomy of nasopalatine nerve in people with Missing Teeth, run by Cairo 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 2 inclusion and 7 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 8 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelmoez Elsharkawy, lecturer (01223194207, moezshark@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
two point discrimination test (time frame: six months). 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 8 Nov 2019.