Sever Mandibular Bone ResorptionNCT07104994
Inferior Alveolar Nerve Translocation With Dental Implant Placement in Severely Resorbed Mandibles
A study testing Dental implant in people with Sever Mandibular Bone Resorption and Sensory Defect, run by University of Science and Technology, Yemen at 1 site in Yemen.
Trial summary
This study investigates the effects of inferior alveolar nerve lateralization on the post-implant insertion sensory outcome for patients with severe mandibular bone resorption. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sever Mandibular Bone Resorption, Sensory Defect, Implant Failure
- What is being tested?
- Dental implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteYemen
- Study dates
- 11 Jun 2024to 20 May 2025
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All other patients
Who cannot join
- Patients with active infections, uncontrolled diabetes, history of radiotherapy, chemotherapy, or oral cancer surgery were excluded from this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inferior Alveolar Nerve Lateralization and Immediate Dental Implant Placement in Severely Resorbed Mandibles: A Clinical Trial
This study investigates the effects of inferior alveolar nerve lateralization on the post-implant insertion sensory outcome for patients with severe mandibular bone resorption.
Read the detailed description
This is a prospective randomized clinical trial. The study was carried out in patients with posterior mandibular atrophies among selected cases from patients attending the Faculty of Dentistry dental polyclinics, and some private dental clinics in Sana'a city The age of patients was above the age of 18 years All patients received a thorough dental examination (extra-oral and intra-oral examination) in dental clinics using a dental mirror, ball-tipped World Health Organization (WHO) dental prob, and dental tweezers. Sterile examination tools by autoclave class B were used. Clinical examination included Oral health and oral hygiene status, interarch distance, dimensions of the edentulous ridge, and soft tissue condition. Panoramic radiographs were taken to assess the condition of the patients' teeth and jawbone, as well as to detect any oral infections requiring treatment. Surgical procedures are performed to translocate the inferior alveolar nerve to provide a good space for implant insertion. All cases ahs undergone follow-up for post-surgical sensory disturbances.
- Being tested
- Dental implant
- Keywords
- Inferior Alveolar Nerve, Mandibular Atrophy, Dental Implant, Alveolar Ridge Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implantDevice
insertion of dental implants after surgical tranlocation of the inferior alveolar nerve.
| Study group | Role | What they receive |
|---|---|---|
| Dental implant group | Experimental | Not described Receives: Device: Dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cone-beam Computed Tomography (CBCT)
visualize the inferior alveolar canal (IAC) and assess the proximity of the implant to the nerve
Measured: The implant's success rate was determined by primary stability during insertion, assessed by ratchet, and then confirmed by X-ray. CBCTs were taken at 3 months and 4 months after implant insertion to check for marginal bone loss.
Secondary outcomes (1)
Subjective Function Score
Patients rate their perceived sensory function relative to an unaffected area, providing a measure of functional impairment.
Measured: Neurosensory evaluation was carried out on the 1st and 7th postoperative day and every month thereafter for up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start11 Jun 2024
- Primary completion12 Apr 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sever Mandibular Bone ResorptionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Science and Technology, Yemen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ali Al-wesabi, University of Science and Technology, Yemen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104994
- Sponsor's protocol ID
- OMFS:14/06/2024
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hwaiti HS, Al-Rubidi YA, Al-Ashwal A, Al-Hadi Y, Al-Kibsi T, Al-Wesabi MA. Inferior alveolar nerve relocation and immediate dental implant placement in severely resorbed mandibles: a prospective clinical case series. BMC Oral Health. 2025 Dec 13;26(1):119. doi: 10.1186/s12903-025-07492-z.
PubMed 41388273
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inferior Alveolar Nerve Lateralization and Immediate Dental Implant Placement in Severely Resorbed Mandibles: A Clinical Trial
- ClinicalTrials.gov ID
- NCT07104994
- Acronym / sponsor ID
- OMFS:14/06/2024
- Keywords
- Inferior Alveolar Nerve, Mandibular Atrophy, Dental Implant, Alveolar Ridge Resorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Science and Technology, YemenUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 12 Apr 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 5 Aug 2025 (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 investigates the effects of inferior alveolar nerve lateralization on the post-implant insertion sensory outcome for patients with severe mandibular bone resorption.
Detailed description
This is a prospective randomized clinical trial. The study was carried out in patients with posterior mandibular atrophies among selected cases from patients attending the Faculty of Dentistry dental polyclinics, and some private dental clinics in Sana'a city The age of patients was above the age of 18 years All patients received a thorough dental examination (extra-oral and intra-oral examination) in dental clinics using a dental mirror, ball-tipped World Health Organization (WHO) dental prob, and dental tweezers. Sterile examination tools by autoclave class B were used. Clinical examination included Oral health and oral hygiene status, interarch distance, dimensions of the edentulous ridge, and soft tissue condition. Panoramic radiographs were taken to assess the condition of the patients' teeth and jawbone, as well as to detect any oral infections requiring treatment. Surgical procedures are performed to translocate the inferior alveolar nerve to provide a good space for implant insertion. All cases ahs undergone follow-up for post-surgical sensory disturbances.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental implant group | Experimental | Device: Dental implant |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All other patients
Key exclusion criteria (1 listed)
- Patients with active infections, uncontrolled diabetes, history of radiotherapy, chemotherapy, or oral cancer surgery were excluded from this study
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 |
|---|---|---|
| Dental implantinsertion of dental implants after surgical tranlocation of the inferior alveolar nerve. | Device | Dental implant group |
Primary outcome
Cone-beam Computed Tomography (CBCT)
Time frame: The implant's success rate was determined by primary stability during insertion, assessed by ratchet, and then confirmed by X-ray. CBCTs were taken at 3 months and 4 months after implant insertion to check for marginal bone loss.
visualize the inferior alveolar canal (IAC) and assess the proximity of the implant to the nerve
1 secondary outcome
Subjective Function Score
Time frame: Neurosensory evaluation was carried out on the 1st and 7th postoperative day and every month thereafter for up to 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Derived from this study: PubMed 41388273Hwaiti HS, Al-Rubidi YA, Al-Ashwal A, Al-Hadi Y, Al-Kibsi T, Al-Wesabi MA. Inferior alveolar nerve relocation and immediate dental implant placement in severely resorbed mandibles: a prospective clinical case series. BMC Oral Health. 2025 Dec 13;26(1):119. doi: 10.1186/s12903-025-07492-z.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implant in people with Sever Mandibular Bone Resorption and Sensory Defect, run by University of Science and Technology, Yemen at 1 site in Yemen.
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 5 Aug 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 Yemen. 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?
Cone-beam Computed Tomography (CBCT) (time frame: The implant's success rate was determined by primary stability during insertion, assessed by ratchet, and then confirmed by X-ray. CBCTs were taken at 3 months and 4 months after implant insertion to check for marginal bone loss.). 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 NCT07104994, which also lists 1 linked publication.
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 5 Aug 2025.