Implant Site ReactionNCT03664219
Neurosensory Disturbances After Inferior Alveolar Nerve Lateralization
A study testing isolation of IAN from implant with collagen membrane in people with Implant Site Reaction, run by Cairo University.
Trial summary
Evaluation of the neurosensory disturbances after inferior alveolar nerve lateralization with and without isolation of the simultaneously placed implants using collagen membrane And measuring the stability of implants 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?
- isolation of IAN from implant with collagen membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Dec 2019
- 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 intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate implant placement.
Who cannot join
- Presence pathological lesions
- Heavy smokers more than 20 cigarettes per day .(24)
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Neurosensory Disturbances After Inferior Alveolar Nerve Lateralization With and Without Isolation of the Simultaneously Placed Implants Using Collagen Membrane
Evaluation of the neurosensory disturbances after inferior alveolar nerve lateralization with and without isolation of the simultaneously placed implants using collagen membrane And measuring the stability of implants after placement .
- Conditions
- Implant Site Reaction
- Being tested
- isolation of IAN from implant with collagen membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isolation of IAN from implant with collagen membraneOther
comparing between the neurosensory disturbances with and without isolation of the inferior alveolar nerve from implant
| Study group | Role | What they receive |
|---|---|---|
| isolation of IAN nerve with collagen membrane | Active comparator | Not described Receives: Other: isolation of IAN from implant with collagen membrane |
| without isolation of the IAN with collagen | Experimental | Not described Receives: Other: isolation of IAN from implant with collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurosensory disturbances - sensation regaining over time subjective ( a scale 1-10 ) and objective checking the area
Assessing the sensation regaining over time subjective ( a scale 1-10 ) and objective checking the area of sensation regaining
Measured: Year
Secondary outcomes (1)
Stability - Osstell device to assess the primary stability of placed dental implant
Osstell device to assess the primary stability of placed dental implant after nerve lateraliztion
Measured: Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Atrophied posterior mandible
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ibrahim hassan bashier garoushi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664219
- Sponsor's protocol ID
- 14422016472019
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Neurosensory Disturbances After Inferior Alveolar Nerve Lateralization With and Without Isolation of the Simultaneously Placed Implants Using Collagen Membrane
- ClinicalTrials.gov ID
- NCT03664219
- Acronym / sponsor ID
- 14422016472019
- Conditions
- Implant Site Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 10 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.
Evaluation of the neurosensory disturbances after inferior alveolar nerve lateralization with and without isolation of the simultaneously placed implants using collagen membrane And measuring the stability of implants after placement .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Atrophied posterior mandible
| Arm | Type | Receives |
|---|---|---|
| isolation of IAN nerve with collagen membrane | Active comparator | Other: isolation of IAN from implant with collagen membrane |
| without isolation of the IAN with collagen | Experimental | Other: isolation of IAN from implant with collagen membrane |
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 intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate implant placement.
Key exclusion criteria (5 listed)
- Presence pathological lesions
- Heavy smokers more than 20 cigarettes per day .(24)
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
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 |
|---|---|---|
| isolation of IAN from implant with collagen membranecomparing between the neurosensory disturbances with and without isolation of the inferior alveolar nerve from implant | Other | isolation of IAN nerve with collagen membrane, without isolation of the IAN with collagen |
Primary outcome
Neurosensory disturbances - sensation regaining over time subjective ( a scale 1-10 ) and objective checking the area
Time frame: Year
Assessing the sensation regaining over time subjective ( a scale 1-10 ) and objective checking the area of sensation regaining
1 secondary outcome
Stability - Osstell device to assess the primary stability of placed dental implant
Time frame: Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
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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 isolation of IAN from implant with collagen membrane in people with Implant Site Reaction, run by Cairo University.
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 5 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 10 Sep 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 ibrahim H garoushi (00201022478985 ext. 0020, garoushi.ibrahim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurosensory disturbances - sensation regaining over time subjective ( a scale 1-10 ) and objective checking the area (time frame: 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 10 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.