Anterior Maxillary Narrow RidgeNCT04386382
Interchangeable Guide in Ridge Splitting Flapless Technique for Implant Placement
A study testing ridge splitting flapless technique using interchangeable guide followed by implant placement in people with Anterior Maxillary Narrow Ridge, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
A clinical trial was conducted to evaluate the accuracy of dental implant placement in narrow ridges after ridge splitting flapless technique using an interchangeable guide. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Maxillary Narrow Ridge
- What is being tested?
- ridge splitting flapless technique using interchangeable guide followed by implant placement
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 1 May 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with anterior maxillary narrow ridge
- Patients with adequate alveolar ridge bone height
- Age ranging from 20-40 years.
- Patients should have adequate oral hygiene
- Patients should be free of soft tissue or oral dental pathology
- Patients who accept to participate in the study.
Who cannot join
- Patients suffering from relevant systemic and/or metabolic diseases
- Patients suffering from immunosuppressive and/or autoimmune diseases
- Heavy smokers.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: Evaluation of Interchangeable Guide in Flapless Ridge Splitting With Simultaneous Implant Placement (Clinical Study)
A clinical trial was conducted to evaluate the accuracy of dental implant placement in narrow ridges after ridge splitting flapless technique using an interchangeable guide.
Read the detailed description
A sample was selected conveniently to fulfill a list of inclusion and exclusion criteria. Then the selected participants underwent ridge splitting with the aid of interchangeable guide. After ridge splitting, all patients had simultaneous implant placement followed by clinical and radiographical evaluation over a period of 6 months.
- Conditions
- Anterior Maxillary Narrow Ridge
- Being tested
- ridge splitting flapless technique using interchangeable guide followed by implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ridge splitting flapless technique using interchangeable guide followed by implant placementProcedure or surgery
An informed consent is taken from all the patients
- Presurgical phase:
- Proper dental and medical history.
- Scaling and oral hygiene measurements.
- Clinical examination.
- Radiographic examination. Clinical bucco-lingual measurements was done using calipers to ensure the patients would meet our initial inclusion criteria prior to further investigations.
III. Fabrication of interchangeable surgical guide stent from primary impression:
- Optical scanning of the dental casts was done using Ceramill map 400
- surgical stent was designed using Mimics Innovation Suite 19 ™ software.
- Series of creating and designing special 3D virtual guide slits and boxes that can accommodate and precisely fit the tools used for the ridge splitting technique.
All patients will be operated under local anesthesia, stent was placed on ridge and adapted well after disinfection osteotomy was done using piezotome splitting tips Implant-insertion was started immediately
| Study group | Role | What they receive |
|---|---|---|
| ridge splitting flapless technique using interchangeable guide | Experimental | Fabrication of interchangeable surgical guide stent:
* Optical scanning of the dental casts was done using Ceramill map 400
* The treatment plan and the surgical stent were designed using Mimics Innovation Suite 19 ™ software
* Series of creating and designing special 3D virtual guide slits and boxes that can accommodate and precisely fit the tools used for the ridge splitting technique. Receives: Procedure: ridge splitting flapless technique using interchangeable guide followed by implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluaion
post operative complication (presence or absence of any sign of swelling or infection)
Measured: After 1 week
Postoperative Pain
Visual Analouge Scale (VAS) 0=no pain
- mild pain; it is easily tolerated
- moderate pain; it is causing discomfort but bearable.
- severe pain; it is causing discomfort, hardly tolerated and unbearable.
Measured: After 1 week
Change of bone width from baseline measurements
Cone beam computed tomography (CBCT) was used to evaluate bone width and density to all patients by doing CBCT at time intervals
Measured: Baseline, 1 week, 3 months and 6 months
Secondary outcomes (1)
operation time
Evaluation of the operating time
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Oct 2019
- Primary completion10 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Maxillary Narrow 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
- 8 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386382
- Sponsor's protocol ID
- Ridge splitting
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 13 May 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 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Interchangeable Guide in Flapless Ridge Splitting With Simultaneous Implant Placement (Clinical Study)
- ClinicalTrials.gov ID
- NCT04386382
- Acronym / sponsor ID
- Ridge splitting
- Conditions
- Anterior Maxillary Narrow Ridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 13 May 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.
A clinical trial was conducted to evaluate the accuracy of dental implant placement in narrow ridges after ridge splitting flapless technique using an interchangeable guide.
Detailed description
A sample was selected conveniently to fulfill a list of inclusion and exclusion criteria. Then the selected participants underwent ridge splitting with the aid of interchangeable guide. After ridge splitting, all patients had simultaneous implant placement followed by clinical and radiographical evaluation over a period of 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ridge splitting flapless technique using interchangeable guide | Experimental | Procedure: ridge splitting flapless technique using interchangeable guide followed by implant placementFabrication of interchangeable surgical guide stent: * Optical scanning of the dental casts was done using Ceramill map 400 * The treatment plan and the surgical stent were designed using Mimics Innovation Suite 19 ™ software * Series of creating and designing special 3D virtual guide slits and boxes that can accommodate and precisely fit the tools used for the ridge splitting technique. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with anterior maxillary narrow ridge
- Patients with adequate alveolar ridge bone height
- Age ranging from 20-40 years.
- Patients should have adequate oral hygiene
- Patients should be free of soft tissue or oral dental pathology
Key exclusion criteria (3 listed)
- Patients suffering from relevant systemic and/or metabolic diseases
- Patients suffering from immunosuppressive and/or autoimmune diseases
- Heavy smokers.
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 |
|---|---|---|
| ridge splitting flapless technique using interchangeable guide followed by implant placementAn informed consent is taken from all the patients I. Presurgical phase: 1. Proper dental and medical history. 2. Scaling and oral hygiene measurements. 3. Clinical examination. 4. Radiographic examination. Clinical bucco-lingual measurements was done using calipers to ensure the patients would meet our initial inclusion criteria prior to further investigations. III. Fabrication of interchangeable surgical guide stent from primary impression: 1. Optical scanning of the dental casts was done using Ceramill map 400 2. surgical stent was designed using Mimics Innovation Suite 19 ™ software. 3. Series of creating and designing special 3D virtual guide slits and boxes that can accommodate and precisely fit the tools used for the ridge splitting technique. All patients will be operated under local anesthesia, stent was placed on ridge and adapted well after disinfection osteotomy was done using piezotome splitting tips Implant-insertion was started immediately | Procedure or surgery | ridge splitting flapless technique using interchangeable guide |
Primary outcome
Clinical evaluaion
Time frame: After 1 week
post operative complication (presence or absence of any sign of swelling or infection)
Postoperative Pain
Time frame: After 1 week
Visual Analouge Scale (VAS) 0=no pain 1. mild pain; it is easily tolerated 2. moderate pain; it is causing discomfort but bearable. 3. severe pain; it is causing discomfort, hardly tolerated and unbearable.
Change of bone width from baseline measurements
Time frame: Baseline, 1 week, 3 months and 6 months
Cone beam computed tomography (CBCT) was used to evaluate bone width and density to all patients by doing CBCT at time intervals
1 secondary outcome
operation time
Time frame: During the procedure
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 13 May 2020.
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 ridge splitting flapless technique using interchangeable guide followed by implant placement in people with Anterior Maxillary Narrow 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 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 13 May 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?
Clinical evaluaion (time frame: After 1 week). The study lists 3 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 13 May 2020.