Anterior TeethNCT04049435
Horizontal Bone Gain Using Titanium Sheet (Case Series Study ).
An observational study of Anterior Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
The horizontal deficient anterior maxilla less than 3mm presents considerable challenges for surgical and prosthetic reconstruction. caused by trauma , infection, congenitally missing teeth or resorption subsequent to dental extractions hampers dental implant placement(Aghaloo \& Moy, 2007) Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Teeth
- What is being tested?
- Assessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxilla
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2019to 1 Oct 2021
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Case series
Who may be able to join
- Horizontal deficient anterior maxilla < 3mm.
- All ages >18 years
Who cannot join
- 1. Patients systemic disease or immunocomprmized status that may affect normal healing of bone, and predictable outcome.
- 2. Patients with history of previous grafting procedure 3. Patients with physical and psychological intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Horizontal Bone Gain Using Patient Specific Titanium Sheet: a Novel Protocol for Treatment of Horizontal Deficiency in the Anterior Maxilla (Case Series Study ).
The horizontal deficient anterior maxilla less than 3mm presents considerable challenges for surgical and prosthetic reconstruction. caused by trauma , infection, congenitally missing teeth or resorption subsequent to dental extractions hampers dental implant placement(Aghaloo \& Moy, 2007)
Read the detailed description
The successful use of dental implants for replacing missing dentition requires adequate available bone in the treatment planning phase and inserting the implant in the correct 3D position to achieve good esthetic and function outcomes.(Rieder et al., 2016)
The horizontal deficient anterior maxilla presents considerable challenges for surgical and prosthetic reconstruction. Inadequate alveolar ridge width caused by trauma , infection, congenitally missing teeth or resorption subsequent to dental extractions hampers dental implant placement (Aghaloo \& Moy, 2007)
Avariety of bone augmentation technigue have been described to enhance the bone volume of the deficient implant recipient site such as autogenous bone graft ,synthetic bone graft ,distraction osteogenesis ,ridge splitting, guided bone regeneration(Rakhmatia, Ayukawa, Furuhashi, \& Koyano, 2013)(Gulinelli et al., 2017)
Autograft remain the gold standard with the capacity to regenerate and forming new bone through its osteogenic ,osteoconductive and osteoinductive properties which can be obtained from chin area (Donos, Mardas, \& Chadha, 2008).
Due to the limited availabity of autograft in case of sever resorped ridge ,xenogrft can be mixed to increase the amount of bone applied to the defective area(Monje et al., 2015)
However considerable graft resorption following augmentation and the graft was not sufficiently stable during the healing period ,the titanium membrane or sheet used to overcome this problem(Andreasi Bassi et al., 2016)
The titanium sheet is non resorbable membrane , impermeable ,rigid acts as space maintainance, clot protection , a barrier preventing bacterial contamination of the gaft , stopping the graft resorption , less morbid,less operative time , more accurate for contour reconstruction than the well known autogenous bone technique (Andreasi Bassi et al., 2016)
Computer aided design/computer aided manufacturing technology (CAD/CAM) have been established in creation of three dimensional(3D) framework , Digitally virtually planned regenerated ridge was created from a cone-beam computerized tomography (CBCT) using specialized DICOM image ( Digital imaging and communication in medicine reconstructing 3D surgical model, and the design of the titanium sheet with the location of the bone screws was preserved. The new 3D surgical model with the simulated surgery was used to fabricate titanium sheet positioning with all required dimensions decreasing the overall operative time .(Al-Ardah et al., 2018)
The quality of newly formed bone will be evaluated by histologically at the time of implant placement , core biopsies will be retrieved . the specimen will immediately fixed in 10% buffered formalin for 1 week, then decalcified and processed according to standardized protocol Ethylenediamine-tetracetic acid (EDTA)-formic acid combination differentiating the newly formed bone end from the native bone end for histologic analysis(Atef, Hakam, Elfaramawey, Abou-Elfetouh, \& Ekram, 2014)
Following postoperative healing period of 6 months CBCT scan will take to evaluate the horizontal bone gain and planning of implant surgery(Mendoza-Azpur, Fuente, Chavez, Valdivia, \& Khouly, 2019)
- Conditions
- Anterior Teeth
- Being tested
- Assessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxillaDevice
Assessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxilla
| Study group | Role | What they receive |
|---|---|---|
| horizontal deficiency anterior maxilla | Using the titanium sheet in augmentation of horizontally deficient anterior maxilla will be efficient, time saving, accurate reconstruction Receives: Device: Assessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxilla |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal bone gain
Distanc buccolingually
Measured: after 6 months
Secondary outcomes (1)
Gained bone quality measured by histomorphomerty examination of core biopsy
Histomorphometry of core biopsy
Measured: after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start25 Sep 2019 (estimated)
- Primary completion31 Oct 2020 (estimated)
- Study completion1 Oct 2021 (estimated)
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 Anterior TeethStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelwakeel mohamed abdelrahman hamam, Cairo University
- Investigators
- Abdelwakeel Mohammed, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049435
- Sponsor's protocol ID
- OMFS 3-3-14
- Status last verified
- Aug 2019
- First submitted
- 2 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70.
PubMed 18437791
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Horizontal Bone Gain Using Patient Specific Titanium Sheet: a Novel Protocol for Treatment of Horizontal Deficiency in the Anterior Maxilla (Case Series Study ).
- ClinicalTrials.gov ID
- NCT04049435
- Acronym / sponsor ID
- OMFS 3-3-14
- Conditions
- Anterior Teeth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Sep 2019 (estimated)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 8 Aug 2019 (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.
The horizontal deficient anterior maxilla less than 3mm presents considerable challenges for surgical and prosthetic reconstruction. caused by trauma , infection, congenitally missing teeth or resorption subsequent to dental extractions hampers dental implant placement(Aghaloo \& Moy, 2007)
Detailed description
The successful use of dental implants for replacing missing dentition requires adequate available bone in the treatment planning phase and inserting the implant in the correct 3D position to achieve good esthetic and function outcomes.(Rieder et al., 2016)
The horizontal deficient anterior maxilla presents considerable challenges for surgical and prosthetic reconstruction. Inadequate alveolar ridge width caused by trauma , infection, congenitally missing teeth or resorption subsequent to dental extractions hampers dental implant placement (Aghaloo \& Moy, 2007)
Avariety of bone augmentation technigue have been described to enhance the bone volume of the deficient implant recipient site such as autogenous bone graft ,synthetic bone graft ,distraction osteogenesis ,ridge splitting, guided bone regeneration(Rakhmatia, Ayukawa, Furuhashi, \& Koyano, 2013)(Gulinelli et al., 2017)
Autograft remain the gold standard with the capacity to regenerate and forming new bone through its osteogenic ,osteoconductive and osteoinductive properties which can be obtained from chin area (Donos, Mardas, \& Chadha, 2008).
Due to the limited availabity of autograft in case of sever resorped ridge ,xenogrft can be mixed to increase the amount of bone applied to the defective area(Monje et al., 2015)
However considerable graft resorption following augmentation and the graft was not sufficiently stable during the healing period ,the titanium membrane or sheet used to overcome this problem(Andreasi Bassi et al., 2016)
The titanium sheet is non resorbable membrane , impermeable ,rigid acts as space maintainance, clot protection , a barrier preventing bacterial contamination of the gaft , stopping the graft resorption , less morbid,less operative time , more accurate for contour reconstruction than the well known autogenous bone technique (Andreasi Bassi et al., 2016)
Computer aided design/computer aided manufacturing technology (CAD/CAM) have been established in creation of three dimensional(3D) framework , Digitally virtually planned regenerated ridge was created from a cone-beam computerized tomography (CBCT) using specialized DICOM image ( Digital imaging and communication in medicine reconstructing 3D surgical model, and the design of the titanium sheet with the location of the bone screws was preserved. The new 3D surgical model with the simulated surgery was used to fabricate titanium sheet positioning with all required dimensions decreasing the overall operative time .(Al-Ardah et al., 2018)
The quality of newly formed bone will be evaluated by histologically at the time of implant placement , core biopsies will be retrieved . the specimen will immediately fixed in 10% buffered formalin for 1 week, then decalcified and processed according to standardized protocol Ethylenediamine-tetracetic acid (EDTA)-formic acid combination differentiating the newly formed bone end from the native bone end for histologic analysis(Atef, Hakam, Elfaramawey, Abou-Elfetouh, \& Ekram, 2014)
Following postoperative healing period of 6 months CBCT scan will take to evaluate the horizontal bone gain and planning of implant surgery(Mendoza-Azpur, Fuente, Chavez, Valdivia, \& Khouly, 2019)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| horizontal deficiency anterior maxilla | – | Device: Assessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxillaUsing the titanium sheet in augmentation of horizontally deficient anterior maxilla will be efficient, time saving, accurate reconstruction |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Case series
Key inclusion criteria (2 listed)
- Horizontal deficient anterior maxilla < 3mm.
- All ages >18 years
Key exclusion criteria (2 listed)
- 1. Patients systemic disease or immunocomprmized status that may affect normal healing of bone, and predictable outcome.
- 2. Patients with history of previous grafting procedure 3. Patients with physical and psychological intolerance
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 |
|---|---|---|
| Assessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxillaAssessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxilla | Device | horizontal deficiency anterior maxilla |
Primary outcome
Horizontal bone gain
Time frame: after 6 months
Distanc buccolingually
1 secondary outcome
Gained bone quality measured by histomorphomerty examination of core biopsy
Time frame: after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Results publication: PubMed 18437791Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70.
- Individual participant dataSharing planned: Yes. Undecided: It is not yet known if there will be a plan to make IPD available.
Related trials for Anterior Teeth
Not yet recruiting
Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
Mild-to-Moderate Mandibular Anterior Crowding
Recruiting
Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
Fluoride Varnishes, Molar Incisor Hypomineralisation
Recruiting
Clinical Evaluation of Bioflx Crowns in Restoring Primary Anterior Teeth
Clinical, Primary Teeth
Not yet recruiting
Clinical Evaluation of Two Post Systems for Single Crown Restoration of Anterior Teeth
Cairo University, Nonvital Tooth
Not yet recruiting
Impact of Various Acceleration Techniques on En-masse Retraction of Maxillary Anterior Teeth
Accelerate Tooth Movement
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.
Abdelwakeel Mohammed principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Teeth, run by Cairo University 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 2 inclusion and 2 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 28 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelwakeel Hamam (01119293865, dwakeel@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal bone gain (time frame: after 6 months). 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 NCT04049435, 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 28 Aug 2019.