Narrow Mandibular RidgeNCT04589806
Change in Mandibular Bone Width Using Two Stages Splitting Approach
A study testing 2-stage ridge splitting in people with Narrow Mandibular Ridge, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Alveolar ridge splitting technique is a commonly used procedure for horizontal ridge augmentation of narrow ridges to allow placement of implants. However, the commonly used one-stage technique can cause malfracture and subsequent necrosis of the fractured part. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Narrow Mandibular Ridge
- What is being tested?
- 2-stage ridge splitting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2018to 21 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 18-60 years old with no gender predilection.
- Patients presenting with posterior mandibular (premolar-molar area) narrow alveolar ridge
- that requires dental implantation.
- Minimum bone width of 3 mm
- Minimum bone height of 10 mm
- Proper inter-occlusal space
Who cannot join
- Uncontrolled diabetes.
- Heavy smokers.
- Current chemotherapy or radiotherapy.
- Alcohol or drug abuse.
- Pregnant women.
- Active infection.
- Inter-occlusal space not less than 7-8 mm.
- Parafunctional habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Bone Width Change Using a Two-stage Ridge Splitting Approach in Narrow Posterior Mandibular Ridge (Clinical Trial)
Alveolar ridge splitting technique is a commonly used procedure for horizontal ridge augmentation of narrow ridges to allow placement of implants. However, the commonly used one-stage technique can cause malfracture and subsequent necrosis of the fractured part.
Read the detailed description
Twelve patients were selected randomly having posterior mandibular narrow edentulous ridge. The sample were selected to match a list of inclusion and exclusion criteria. In the first stage, all patients will underwent a mandibular ridge splitting technique using piezotomes. In the second stage, ridge expansion and implants were placed with only envelope flap. Assessment were included measurement of the buccal and lingual bone surrounding the implants and amount of increase in the bone width from the cone beam computed tomography.
- Conditions
- Narrow Mandibular Ridge
- Being tested
- 2-stage ridge splitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-stage ridge splittingProcedure or surgery
two-stage alveolar ridge splitting technique using piezoelectric device with simultaneous implant placement in order to treat narrow posterior mandibular ridges avoiding the risks of malfracture and necrosis of the split part
| Study group | Role | What they receive |
|---|---|---|
| 2-stage ridge splitting with simultaneous implant placement | Experimental | Not described Receives: Procedure: 2-stage ridge splitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the width of the alveolar bone
using CBCT the width were measured
Measured: at the 1st week and the 4th month
Bone density
using CBCT the bone width were measured
Measured: at the 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 May 2018
- Primary completion21 Dec 2019
- Study completion21 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narrow Mandibular RidgeStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
- Investigators
- Ahmed M Eid, BDS, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589806
- Sponsor's protocol ID
- Narrow mandibular ridge
- Status last verified
- Oct 2020
- First submitted
- 10 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Width Change Using a Two-stage Ridge Splitting Approach in Narrow Posterior Mandibular Ridge (Clinical Trial)
- ClinicalTrials.gov ID
- NCT04589806
- Acronym / sponsor ID
- Narrow mandibular ridge
- Conditions
- Narrow Mandibular Ridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 21 Dec 2019 (actual)
- Study completion
- 21 Dec 2019 (actual)
- First posted
- 19 Oct 2020 (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.
Alveolar ridge splitting technique is a commonly used procedure for horizontal ridge augmentation of narrow ridges to allow placement of implants. However, the commonly used one-stage technique can cause malfracture and subsequent necrosis of the fractured part.
Detailed description
Twelve patients were selected randomly having posterior mandibular narrow edentulous ridge. The sample were selected to match a list of inclusion and exclusion criteria. In the first stage, all patients will underwent a mandibular ridge splitting technique using piezotomes. In the second stage, ridge expansion and implants were placed with only envelope flap. Assessment were included measurement of the buccal and lingual bone surrounding the implants and amount of increase in the bone width from the cone beam computed tomography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2-stage ridge splitting with simultaneous implant placement | Experimental | Procedure: 2-stage ridge splitting |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult patients aged 18-60 years old with no gender predilection.
- Patients presenting with posterior mandibular (premolar-molar area) narrow alveolar ridge
- that requires dental implantation.
- Minimum bone width of 3 mm
- Minimum bone height of 10 mm
Key exclusion criteria (8 listed)
- Uncontrolled diabetes.
- Heavy smokers.
- Current chemotherapy or radiotherapy.
- Alcohol or drug abuse.
- Pregnant women.
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 |
|---|---|---|
| 2-stage ridge splittingtwo-stage alveolar ridge splitting technique using piezoelectric device with simultaneous implant placement in order to treat narrow posterior mandibular ridges avoiding the risks of malfracture and necrosis of the split part | Procedure or surgery | 2-stage ridge splitting with simultaneous implant placement |
Primary outcome
change in the width of the alveolar bone
Time frame: at the 1st week and the 4th month
using CBCT the width were measured
Bone density
Time frame: at the 4th week
using CBCT the bone width were measured
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 Oct 2020.
Related trials for Narrow Mandibular Ridge
Recruiting
Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants With Bone Augmentation in Horizontally Deficient Posterior Mandibular Sites.
Horizontal Atrophy of Edentulous Alveolar Ridge
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.
Ahmed M Eid, BDS principal investigator
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-stage ridge splitting in people with Narrow Mandibular Ridge, run by Hams Hamed Abdelrahman 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 6 inclusion and 8 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 Oct 2020. 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?
change in the width of the alveolar bone (time frame: at the 1st week and the 4th month). The study lists 2 primary outcomes in all. 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 Oct 2020.