Implant Site ReactionNCT03669510
Assessment of the Neurosensory Alteration After Inferior Alveolar Nerve Lateralization
A study testing computer guided IAN lateralization surgical technique in people with Implant Site Reaction, run by Mohamed Reda Mohamed Abdelhady at 1 site in Egypt.
Trial summary
: Assessment of the neurosensory alteration with computer guided inferior alveolar nerve lateralization versus non guided classic technique and measuring stability of implant after placement Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- computer guided IAN lateralization surgical technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 20 Mar 2020
- 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 with with atrophied posterior mandibular ridge
- both sexes
- NO intra oral soft and hard tissue pathology
- NO systematic that contraindicate implant placement
Who cannot join
- Presence pathological lesion
- Heavy smokers more than 20 cigarettes per day.
- patients with systemic disease that may affect normal healing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Neurosensory Alteration With Computer Guided Inferior Alveolar Nerve Lateralization Versus Non Guided Classic Technique
: Assessment of the neurosensory alteration with computer guided inferior alveolar nerve lateralization versus non guided classic technique and measuring stability of implant after placement
- Conditions
- Implant Site Reaction
- Being tested
- computer guided IAN lateralization surgical technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer guided IAN lateralization surgical techniqueOther
Tthe neurosensory alterations with computer guided inferior alveolar nerve lateralization versus non guided classic technique
| Study group | Role | What they receive |
|---|---|---|
| computer gaiuded IAN | Active comparator | Computer guided surgical technique Receives: Other: computer guided IAN lateralization surgical technique |
| Classical technique | Experimental | Non computer guided surgical technique Receives: Other: computer guided IAN lateralization surgical technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the neurosensory alteration- sensation over time subjective(a scale 1-10)
assessing the sensation regaining over time subjective (a scale 1-10 )
Measured: 1 year
Secondary outcomes (1)
Implant stability
Measurements of the implant stability immediately after placement by osstell
Measured: At the placement and after exposure ( 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 posted13 Sep 2018
- Study start1 Jan 2019
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies 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
- Parallel groups
- Model description
- atrophic posterior mandible requiring nerve lateralization
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Reda Mohamed Abdelhady
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Reda Mohamed Abdelhady, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669510
- Sponsor's protocol ID
- 14422016552019
- Status last verified
- Apr 2024
- First submitted
- 11 Sep 2018
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Neurosensory Alteration With Computer Guided Inferior Alveolar Nerve Lateralization Versus Non Guided Classic Technique
- ClinicalTrials.gov ID
- NCT03669510
- Acronym / sponsor ID
- 14422016552019
- Conditions
- Implant Site Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mohamed Reda Mohamed AbdelhadyUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 13 Sep 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.
: Assessment of the neurosensory alteration with computer guided inferior alveolar nerve lateralization versus non guided classic technique and measuring stability of implant after placement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- atrophic posterior mandible requiring nerve lateralization
| Arm | Type | Receives |
|---|---|---|
| computer gaiuded IAN | Active comparator | Other: computer guided IAN lateralization surgical techniqueComputer guided surgical technique |
| Classical technique | Experimental | Other: computer guided IAN lateralization surgical techniqueNon computer guided surgical technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with with atrophied posterior mandibular ridge
- both sexes
- NO intra oral soft and hard tissue pathology
- NO systematic that contraindicate implant placement
Key exclusion criteria (3 listed)
- Presence pathological lesion
- Heavy smokers more than 20 cigarettes per day.
- patients with systemic disease that may affect normal 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 |
|---|---|---|
| computer guided IAN lateralization surgical techniqueTthe neurosensory alterations with computer guided inferior alveolar nerve lateralization versus non guided classic technique | Other | Classical technique, computer gaiuded IAN |
Primary outcome
Assessment of the neurosensory alteration- sensation over time subjective(a scale 1-10)
Time frame: 1 year
assessing the sensation regaining over time subjective (a scale 1-10 )
1 secondary outcome
Implant stability
Time frame: At the placement and after exposure ( 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 19 Apr 2024.
- 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.
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 computer guided IAN lateralization surgical technique in people with Implant Site Reaction, run by Mohamed Reda Mohamed Abdelhady 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 4 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: finished, as of the sponsor's last update on 19 Apr 2024. 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?
Assessment of the neurosensory alteration- sensation over time subjective(a scale 1-10) (time frame: 1 year). 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 19 Apr 2024.