Atrophy of Edentulous Maxillary Alveolar RidgeNCT03629860
Ascending Ramus Versus Chin Cortical Plates for Reconstruction of Atrophic Maxilla
A study testing Atrophic maxillary alveolar ridge augmentation in people with Atrophy of Edentulous Maxillary Alveolar Ridge, run by Cairo University at 1 site in Egypt.
Trial summary
Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial) Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Atrophy of Edentulous Maxillary Alveolar Ridge
- What is being tested?
- Atrophic maxillary alveolar ridge augmentation
- Type of treatment
- Pill or oral medicine, 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 9 Apr 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
- Patients with atrophic maxilla with residual bone height from 3 to 4mm.
- Both sexes
Who cannot join
- Intraoral soft and hard tissue pathology.
- Systemic condition that contraindicate implant basement.
- Psychiatric problems
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo, Al-Manial, 11553
Ahmed Y Zayed, BSD, 01111634311, ahmed.zayed@dentistry.cu.edu.eg
Ahmed Y Usry, BSD, 01140425144, ahmed.zayed.implantology@gmail.com
About this study
Official title: Assessment of Mandibular Ascending Ramus Cortical Plates for Reconstruction of Atrophic Maxillary Ridges Versus Chin Cortical Plates(Randomized Clinical Tial)
Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial)
Read the detailed description
Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial) To know what is better and more efficient chin or ascending ramus cortical plates.
- Being tested
- Atrophic maxillary alveolar ridge augmentation
- Keywords
- Atrophic, augmetation, bone regeneration
- Medical subject headings
- Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrophic maxillary alveolar ridge augmentationProcedure or surgery
Autogenous bone blocks from chin and ascending ramus are obtained and used for reconstruction of atrophic maxillary ridges
| Study group | Role | What they receive |
|---|---|---|
| ascending ramus group | Active comparator | * Local anesthesia will be given to the patient
* flap will be reflected to expose the facial wall of the maxilla then The ascending ramus is accessed.
* A disc bur will be used to make a rectangular osteotomy
* The block bone graft is removed from ascending ramus to recipient site the fixed by mini screws
* Doner site flap is closed by using interrupted internal sutures.
* after atrophic maxillary alveolar ridge augmentation,sub mucosal periosteal releasing cuts is done
* Post-operative medications will be prescribed as follows: amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, metronidazole 5 mg/kg every 8 hours for 7 days Receives: Procedure: Atrophic maxillary alveolar ridge augmentation |
| Chin Group | Active comparator | * Local anesthesia will be given to the patient
* flap will be reflected to expose the facial wall of the maxilla then The chin is accessed.
* A disc bur will be used to make a rectangular osteotomy
* The block bone graft is removed from chin to recipient site the fixed by mini screws
* Doner site flap is closed by using interrupted internal sutures
* after atrophic maxillary alveolar ridge augmentation,submucosal periosteal releasing cuts is done
* Post-operative medications will be prescribed as follows: amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, metronidazole 5 mg/kg every 8 hours for 7days Receives: Procedure: Atrophic maxillary alveolar ridge augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
width and height of the bone gained by the procedure and the new measures from a physiologic vital structures e.g( nasal floor, maxillary sinus or even occlusal plan)
new bone formation
Measured: 6 months
Secondary outcomes (1)
Histomorphometric analysis bone area percent
Nature and quality of new bone histology
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 May 2018
- Primary completion8 Feb 2019 (estimated)
- Study completion9 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Atrophy of Edentulous Maxillary Alveolar RidgeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed yousri said zayed, Cairo University
- Investigators
- Ahmed Y Yousri, Bsd, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629860
- Sponsor's protocol ID
- Ahmed yousri
- Status last verified
- Aug 2018
- First submitted
- 6 Aug 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Websites and papers
Publications
Ali SA, Karthigeyan S, Deivanai M, Kumar A. Implant rehabilitation for atrophic maxilla: a review. J Indian Prosthodont Soc. 2014 Sep;14(3):196-207. doi: 10.1007/s13191-014-0360-4. Epub 2014 Apr 22.
PubMed 25183902Sorni M, Guarinos J, Garcia O, Penarrocha M. Implant rehabilitation of the atrophic upper jaw: a review of the literature since 1999. Med Oral Patol Oral Cir Bucal. 2005 Apr 1;10 Suppl 1:E45-56. English, Spanish.
PubMed 15800467Dym H, Huang D, Stern A. Alveolar bone grafting and reconstruction procedures prior to implant placement. Dent Clin North Am. 2012 Jan;56(1):209-18, x. doi: 10.1016/j.cden.2011.09.005.
PubMed 22117951Bellini CM, Romeo D, Galbusera F, Agliardi E, Pietrabissa R, Zampelis A, Francetti L. A finite element analysis of tilted versus nontilted implant configurations in the edentulous maxilla. Int J Prosthodont. 2009 Mar-Apr;22(2):155-7.
PubMed 19418861Bidra AS, Almas K. Mini implants for definitive prosthodontic treatment: a systematic review. J Prosthet Dent. 2013 Mar;109(3):156-64. doi: 10.1016/S0022-3913(13)60035-9.
PubMed 23522364Chiriac G, Herten M, Schwarz F, Rothamel D, Becker J. Autogenous bone chips: influence of a new piezoelectric device (Piezosurgery) on chip morphology, cell viability and differentiation. J Clin Periodontol. 2005 Sep;32(9):994-9. doi: 10.1111/j.1600-051X.2005.00809.x.
PubMed 16104964Enneking WF, Eady JL, Burchardt H. Autogenous cortical bone grafts in the reconstruction of segmental skeletal defects. J Bone Joint Surg Am. 1980 Oct;62(7):1039-58.
PubMed 7000788Menini M, Signori A, Tealdo T, Bevilacqua M, Pera F, Ravera G, Pera P. Tilted implants in the immediate loading rehabilitation of the maxilla: a systematic review. J Dent Res. 2012 Sep;91(9):821-7. doi: 10.1177/0022034512455802. Epub 2012 Jul 31.
PubMed 22851285Peleg M, Mazor Z, Garg AK. Augmentation grafting of the maxillary sinus and simultaneous implant placement in patients with 3 to 5 mm of residual alveolar bone height. Int J Oral Maxillofac Implants. 1999 Jul-Aug;14(4):549-56.
PubMed 10453671Topolovec-Vranic J, Canzian S, Innis J, Pollmann-Mudryj MA, McFarlan AW, Baker AJ. Patient satisfaction and documentation of pain assessments and management after implementing the adult nonverbal pain scale. Am J Crit Care. 2010 Jul;19(4):345-54; quiz 355. doi: 10.4037/ajcc2010247.
PubMed 20595216
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Mandibular Ascending Ramus Cortical Plates for Reconstruction of Atrophic Maxillary Ridges Versus Chin Cortical Plates(Randomized Clinical Tial)
- ClinicalTrials.gov ID
- NCT03629860
- Acronym / sponsor ID
- Ahmed yousri
- Keywords
- Atrophic, augmetation, bone regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 8 Feb 2019 (estimated)
- Study completion
- 9 Apr 2019 (estimated)
- First posted
- 14 Aug 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 ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial)
Detailed description
Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial) To know what is better and more efficient chin or ascending ramus cortical plates.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial)
| Arm | Type | Receives |
|---|---|---|
| ascending ramus group | Active comparator | Procedure: Atrophic maxillary alveolar ridge augmentation* Local anesthesia will be given to the patient * flap will be reflected to expose the facial wall of the maxilla then The ascending ramus is accessed. * A disc bur will be used to make a rectangular osteotomy * The block bone graft is removed from ascending ramus to recipient site the fixed by mini screws * Doner site flap is closed by using interrupted internal sutures. * after atrophic maxillary alveolar ridge augmentation,sub mucosal periosteal releasing cuts is done * Post-operative medications will be prescribed as follows: amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, metronidazole 5 mg/kg every 8 hours for 7 days |
| Chin Group | Active comparator | Procedure: Atrophic maxillary alveolar ridge augmentation* Local anesthesia will be given to the patient * flap will be reflected to expose the facial wall of the maxilla then The chin is accessed. * A disc bur will be used to make a rectangular osteotomy * The block bone graft is removed from chin to recipient site the fixed by mini screws * Doner site flap is closed by using interrupted internal sutures * after atrophic maxillary alveolar ridge augmentation,submucosal periosteal releasing cuts is done * Post-operative medications will be prescribed as follows: amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, metronidazole 5 mg/kg every 8 hours for 7days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with atrophic maxilla with residual bone height from 3 to 4mm.
- Both sexes
Key exclusion criteria (3 listed)
- Intraoral soft and hard tissue pathology.
- Systemic condition that contraindicate implant basement.
- Psychiatric problems
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 |
|---|---|---|
| Atrophic maxillary alveolar ridge augmentationAutogenous bone blocks from chin and ascending ramus are obtained and used for reconstruction of atrophic maxillary ridges | Procedure or surgery | Chin Group, ascending ramus group |
Primary outcome
width and height of the bone gained by the procedure and the new measures from a physiologic vital structures e.g( nasal floor, maxillary sinus or even occlusal plan)
Time frame: 6 months
new bone formation
1 secondary outcome
Histomorphometric analysis bone area percent
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Background: PubMed 25183902Ali SA, Karthigeyan S, Deivanai M, Kumar A. Implant rehabilitation for atrophic maxilla: a review. J Indian Prosthodont Soc. 2014 Sep;14(3):196-207. doi: 10.1007/s13191-014-0360-4. Epub 2014 Apr 22.
- Background: PubMed 15800467Sorni M, Guarinos J, Garcia O, Penarrocha M. Implant rehabilitation of the atrophic upper jaw: a review of the literature since 1999. Med Oral Patol Oral Cir Bucal. 2005 Apr 1;10 Suppl 1:E45-56. English, Spanish.
- Background: PubMed 22117951Dym H, Huang D, Stern A. Alveolar bone grafting and reconstruction procedures prior to implant placement. Dent Clin North Am. 2012 Jan;56(1):209-18, x. doi: 10.1016/j.cden.2011.09.005.
- Background: PubMed 19418861Bellini CM, Romeo D, Galbusera F, Agliardi E, Pietrabissa R, Zampelis A, Francetti L. A finite element analysis of tilted versus nontilted implant configurations in the edentulous maxilla. Int J Prosthodont. 2009 Mar-Apr;22(2):155-7.
- Background: PubMed 23522364Bidra AS, Almas K. Mini implants for definitive prosthodontic treatment: a systematic review. J Prosthet Dent. 2013 Mar;109(3):156-64. doi: 10.1016/S0022-3913(13)60035-9.
- Background: PubMed 16104964Chiriac G, Herten M, Schwarz F, Rothamel D, Becker J. Autogenous bone chips: influence of a new piezoelectric device (Piezosurgery) on chip morphology, cell viability and differentiation. J Clin Periodontol. 2005 Sep;32(9):994-9. doi: 10.1111/j.1600-051X.2005.00809.x.
- Background: PubMed 7000788Enneking WF, Eady JL, Burchardt H. Autogenous cortical bone grafts in the reconstruction of segmental skeletal defects. J Bone Joint Surg Am. 1980 Oct;62(7):1039-58.
- Background: PubMed 22851285Menini M, Signori A, Tealdo T, Bevilacqua M, Pera F, Ravera G, Pera P. Tilted implants in the immediate loading rehabilitation of the maxilla: a systematic review. J Dent Res. 2012 Sep;91(9):821-7. doi: 10.1177/0022034512455802. Epub 2012 Jul 31.
- Background: PubMed 10453671Peleg M, Mazor Z, Garg AK. Augmentation grafting of the maxillary sinus and simultaneous implant placement in patients with 3 to 5 mm of residual alveolar bone height. Int J Oral Maxillofac Implants. 1999 Jul-Aug;14(4):549-56.
- Background: PubMed 20595216Topolovec-Vranic J, Canzian S, Innis J, Pollmann-Mudryj MA, McFarlan AW, Baker AJ. Patient satisfaction and documentation of pain assessments and management after implementing the adult nonverbal pain scale. Am J Crit Care. 2010 Jul;19(4):345-54; quiz 355. doi: 10.4037/ajcc2010247.
- Individual participant dataSharing planned: Undecided. Websites and papers
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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.
Ahmed Y Yousri, Bsd principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrophic maxillary alveolar ridge augmentation in people with Atrophy of Edentulous Maxillary Alveolar Ridge, 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 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: status not confirmed, as of the sponsor's last update on 14 Aug 2018. 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 Ahmed Y Zayed, BSD (00201111634311 ext. 00201140425144, ahmed.zayed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
width and height of the bone gained by the procedure and the new measures from a physiologic vital structures e.g( nasal floor, maxillary sinus or even occlusal plan) (time frame: 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 NCT03629860, which also lists 10 linked publications.
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 14 Aug 2018.