Alveolar Ridge AugmentationNCT03592381
Ridge Expansion by Osseodensification Simultaneously With Implant Placement in Narrow Alveolar Ridges
A study testing Ridge Expansion by ossedensification and ridge expansion by ridge splitting in people with Alveolar Ridge Augmentation, run by Cairo University at 1 site in Egypt.
Trial summary
Narrow alveolar ridges with a thickness equal or less than 5 mm requires bone augmentation procedures before or at the time of implant placement. (Anitua, Begoña, and Orive 2013) Several surgical techniques have been utilized for the reconstruction of deficient alveolar ridges such as block onlay graft augmentation… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Alveolar Ridge Augmentation
- What is being tested?
- Ridge Expansion by ossedensification and ridge expansion by ridge splitting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2018to Mar 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with at least one missing tooth in need of replacement.
- Patients having a Bucco-lingual/palatal width of the edentulous alveolar ridge less than 6 mm with a minimum of 3mm residual bone width.
- Patients having at least 11 mm residual bone height at the proposed edentulous area.
- The recipient bed of the implant should be free from any pathological conditions.
- No history of diagnosed bone disease or medication known to affect bone metabolism.
- Patients who are cooperative, motivated, and hygiene conscious.
Who cannot join
- Patients incapable to undergoing minor oral surgical procedures.
- Patients with insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.
- Patients who have any systemic condition that may contraindicate implant therapy.
- Patients with modifying habits affecting osteointegration for example, smoking and alcoholism.
- Patients with parafunctional habits that can overload the implant, such as bruxism and clenching.
- Patients with impractical expectations about the esthetic outcome of implant therapy.
Show all 9Show fewer
- Patients in the growth stage with mixed dentition.
- Patients with a history of drug abuse.
- Patients with a history of psychiatric disorder.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
The Faculty of Dentistry -Cairo University
Cairo
radwa a elmaghrabi, bsc, 00201018626244, radwaelmaghrabi@gmail.com
About this study
Official title: Ridge Expansion by Osseodensification Drilling Compared to Ridge Splitting Technique Simultaneously With Implant Placement in Narrow Alveolar Ridges: A Randomized Controlled Trial
Narrow alveolar ridges with a thickness equal or less than 5 mm requires bone augmentation procedures before or at the time of implant placement. (Anitua, Begoña, and Orive 2013) Several surgical techniques have been utilized for the reconstruction of deficient alveolar ridges such as block onlay graft augmentation, guided bone regeneration, distraction osteogenesis , ridge splitting and/or ridge expansion(McAllister and Haghighat 2007). A new bone drilling technique named Osseodensification facilitates horizontal ridge expansion. Studies are needed to validate the effectiveness of osseodensification as a lateral ridge augmentation procedure that aims at increasing the thickness of atrophic ridges, thus maintaining ridge integrity and allowing for implant placement with enhanced stability. The null hypothesis Proposes no difference in the bone width gain following the osseodensification drilling system compared to the ridge splitting technique with simultaneously placed implants in narrow alveolar ridges.
Read the detailed description
The aim of the study is to evaluate ridge width gain in patients with narrow alveolar ridges following osseodensification as compared to ridge splitting with simultaneous implant placement using CBCT.
Interventions:
- Pre-operative phase:
Clinical Examination:
- Visual examination, palpation and inspection of the entire oral and Para-oral tissues.
- Preoperative alginate impressions for both the maxillary and the mandibular Ridges.
- Full mouth scaling and root planing, followed by oral hygiene instructions.
- The Bucco-Lingual/Palatal alveolar ridge width measurement at site of interest using a bone caliper.
- Study casts will be made in order to properly evaluate the inter-arch space, occlusion type and direction of forces in regard to the site of the future implant.
Radiographic Examination:
- A panoramic radiograph for screening purposes:
- Estimating the residual bone height.
- Verify the absence of any pathology in the bone.
- Cone beam computed Tomography (CBCT) for Diagnostic purposes:
- Detect the Bucco-lingual/palatal alveolar ridge width and height at the site of interest.
- Detect approximation to any anatomical boundaries (e.g.mental foramen, maxillary sinus floor.)
- Detect bone type.
II. Surgical phase:
All procedures will be done under strictly aseptic conditions
- Patients will be anesthetized at the surgical site by the appropriate method using Articaine Hydrochloride 4%.
- At the site a horizontal incision will be created, extending the entire length of the edentulous area, extending one tooth mesial and distal. Anterior and/or posterior vertical releasing incision will be made as needed.
- Full thickness mucoperiosteal flap will be raised with complete exposure of the alveolar bone.
- Bone width will be reconfirmed intrasurgically using a bone caliper. Measurements will be taken at around 1 mm below the crestal margin, to the nearest 0.5mm. Alveolar ridge width measurements will be repeated at second stage surgery.
- A.For the intervention:
- Drilling of bone will commence using the Pilot Drill to the desired depth (Drill speed 800-1500 rpm with copious irrigation).
- Osseodensification drilling will begin with the narrowest Densah Bur. (Counterclockwise drill speed 800-1500 rpm with copious irrigation). If when running the bur into the osteotomy a feeling of haptic feedback of pushing up and out of the osteotomy, repetitively lifting off and reapplying pressure with a pumping motion will be applied until the desired depth is reached.
- Densah Burs will be used sequentially in small increments. As the bur diameter increases, the bone will slowly expand to the final diameter.
- The osteotomy final preparation diameter would be an average diameter that measures 0.5-0.8 mm smaller than the implant average diameter in soft bone, and In hard bone, diameter that measures 0.2-0.5 mm smaller than the implant average diameter.
- Implant placement using the drill motor initially, then Finishing placement of the implant to depth with a torque-indicating wrench.
- If < 1mm of buccal bone thickness has resulted after osseodensification, bone grafting post implant placement and complete implant coverage will be considered
5.B.For the control:
- A bone crestal incision will be created, using the piezo-electric surgical tips. The cut will be done through the cortical bone to reach the trabecular bone.
- One/two vertical cuts will be created by piezo-drill as needed connecting, to the crestal cut.
- Conventional Drills will be used for osteotomy preparation by wedging it between the two plates of bone.
- The implant with the proper length and diameter will be gradually engaged to separate the buccal and Lingual/palatal bone until full seating is achieved.
- Cover screws will be placed on the implants. 7.Closure of the flap will be done by interrupted sutures using 4-0 resorbable suture materials. III. Post-operative phase: Post-operative instructions and medication: Patient is recommended to:
- Maintain a soft diet to avoid trauma to the surgical site.
- Place a cold compress superficially on the skin overlying the surgical site immediately. Apply for 30 minutes, then off for 20-30 minutes. This should be done on a near continuous basis (or as much as possible) for the first 48 hours.
- Maintain Oral hygiene but avoid surgical site for the first 4 days after surgery.
- Medications (Ferrigno et al. 2005)( Garcez-Filho et al.2015) • Augmentin* (1g tablets) will be prescribed twice daily for 5 days to avoid possibility of infection.
- Ibuprofen** 600mg four times daily for one week.
- Voltarene*** (75 mg injection I.M.) will be used in case of severe pain, as a rescue.
- Hexitol**** 0.12% chlorhexidine mouth rinse for 2 weeks.
- Sutures will be removed after 2 weeks
- Final restoration will be completed after 6 months
- Augmentin 1g. Medical union pharmaceuticals co. Abu Sultan, Ismailia, Egypt. **BRUFEN 600 (Ibuprofen 600 mg). Kahira Pharm. \& Chem. Ind. Co., Under licence from: Abbott Laboratories.
- Voltarene® 75mg/3ml (IM). Diclofenac natrium. NOVARTIS PHARMA. S.A.E.
- Hexitol Chlorhexidine Hcl 125 mg / 100 ml. Arab Drug Company (ADCO).
- Conditions
- Alveolar Ridge Augmentation
- Being tested
- Ridge Expansion by ossedensification, ridge expansion by ridge splitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ridge Expansion by ossedensificationProcedure or surgery
Osseodensification is a new concept facilitated by Densah® Burs which are a multi- fluted osteotome like drilling instrumentsThe idea behind the technique is using a non-subtractive drilling mode that preserves bone and increases its density along the osteotomy walls instead of cutting it away (Huwais and Meyer 2015)
ridge expansion by ridge splittingProcedure or surgery
using the piezotome,Piezoelectric ridge splitting allows exact, clean, and smooth even curved cutting of the bone tissue, with proper visibility.
| Study group | Role | What they receive |
|---|---|---|
| Ridge expansion by osseodensification | Experimental | Ridge expansion and osteotomy drilling by osseodensification in conjunction with simultaneous implant placement in narrow ridges. Receives: Procedure: Ridge Expansion by ossedensification |
| Ridge expansion by ridge splitting | Active comparator | Ridge expansion by ridge splitting using the piezotome in conjunction with simultaneous implant placement in narrow ridges. Receives: Procedure: ridge expansion by ridge splitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone width
Using Cone beam computed tomography bone width gain will be reported in millimeters.
Measured: Baseline and six month post surgically
Secondary outcomes (5)
Change in Implant stability Quotients
using the Periotest, the implant stability's as an Assessment of osseointegration of dental implants will be reported numerically.Periotest value range -8 to +50. from -8 to 0;Good osseointegration; the implant is well integrated and can be loaded. from+10 to +50;Osseointegration is insufficient; the implant must not be loaded.
Measured: at the time of surgery and 6 month post surgical
soft tissue healing at 1 week using the Healing index by Landry,Turnbull and Howley (1988) to describe the extent of clinical healing after periodontal surgery.
Assessed numerically using Healing index by Landry,Turnbull and Howley 1988.The Healing index scores healing with a 5-level score index evaluated with the following parameters: tissue color,presence of granulation tissue, bleeding
,suppuration and epithelialisation. by applying a dichotomic scoring system (0/1) with a total score of 5: presence/absence of redness; presence/absence of granulation tissue; presence/absence of suppuration; degree of tissue epithelialization (partial/complete); presence/absence of bleeding.A score range of 1 to 5 is given, with 1 associated with very poor healing and 5 being excellent healing.
Measured: 1 week post surgically.
soft tissue healing at 2 weeks using the Healing index by Landry,Turnbull and Howley 1988 to describe the extent of clinical healing after periodontal surgery.
Assessed numerically using Healing index by Landry,Turnbull and Howley 1988.The Healing index scores healing with a 5-level score index evaluated with the following parameters: tissue color,presence of granulation tissue, bleeding
,suppuration and epithelialisation. by applying a dichotomic scoring system (0/1) with a total score of 5: presence/absence of redness; presence/absence of granulation tissue; presence/absence of suppuration; degree of tissue epithelialization (partial/complete); presence/absence of bleeding.A score range of 1 to 5 is given, with 1 associated with very poor healing and 5 being excellent healing.
Measured: 2 weeks post surgically
Changes in Crestal Bone level
using the Cone beam computed tomography crestal bone level differences will be evaluated and reported in millimeters.
Measured: at the time of enrollment and 6 month post surgically
Pain scale using the numerical Visual analog scale.
Using the numerical Visual analog scale. Pain sensation will be evaluated and reported. The visual analog scale is a continuous scale made of a horizontal line, about 10 centimeters (100 mm) in length, anchored by 2 extremes descriptors,"no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100).
Measured: 1 week post surgically
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start30 Aug 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge AugmentationStudies 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
- Parallel groups
- Model description
- Double Blinded, Parallel group, Randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Abdelhamid ElMaghrabi, Cairo University
- Investigators
- Radwa A ElMaghrabi, BSC, Principal investigator, Cairo UniversityAmr zahran, PHD, Study director, Cairo UniversityAhmed Al barbary, PHD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592381
- Sponsor's protocol ID
- 14422015497758
- Status last verified
- Jul 2018
- First submitted
- 25 Jun 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Expansion by Osseodensification Drilling Compared to Ridge Splitting Technique Simultaneously With Implant Placement in Narrow Alveolar Ridges: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03592381
- Acronym / sponsor ID
- 14422015497758
- Conditions
- Alveolar Ridge Augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Aug 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 19 Jul 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.
Narrow alveolar ridges with a thickness equal or less than 5 mm requires bone augmentation procedures before or at the time of implant placement. (Anitua, Begoña, and Orive 2013) Several surgical techniques have been utilized for the reconstruction of deficient alveolar ridges such as block onlay graft augmentation, guided bone regeneration, distraction osteogenesis , ridge splitting and/or ridge expansion(McAllister and Haghighat 2007). A new bone drilling technique named Osseodensification facilitates horizontal ridge expansion. Studies are needed to validate the effectiveness of osseodensification as a lateral ridge augmentation procedure that aims at increasing the thickness of atrophic ridges, thus maintaining ridge integrity and allowing for implant placement with enhanced stability. The null hypothesis Proposes no difference in the bone width gain following the osseodensification drilling system compared to the ridge splitting technique with simultaneously placed implants in narrow alveolar ridges.
Detailed description
The aim of the study is to evaluate ridge width gain in patients with narrow alveolar ridges following osseodensification as compared to ridge splitting with simultaneous implant placement using CBCT.
Interventions:
- Pre-operative phase:
Clinical Examination:
- Visual examination, palpation and inspection of the entire oral and Para-oral tissues.
- Preoperative alginate impressions for both the maxillary and the mandibular Ridges.
- Full mouth scaling and root planing, followed by oral hygiene instructions.
- The Bucco-Lingual/Palatal alveolar ridge width measurement at site of interest using a bone caliper.
- Study casts will be made in order to properly evaluate the inter-arch space, occlusion type and direction of forces in regard to the site of the future implant.
Radiographic Examination:
- A panoramic radiograph for screening purposes:
- Estimating the residual bone height.
- Verify the absence of any pathology in the bone.
- Cone beam computed Tomography (CBCT) for Diagnostic purposes:
- Detect the Bucco-lingual/palatal alveolar ridge width and height at the site of interest.
- Detect approximation to any anatomical boundaries (e.g.mental foramen, maxillary sinus floor.)
- Detect bone type.
II. Surgical phase:
All procedures will be done under strictly aseptic conditions
- Patients will be anesthetized at the surgical site by the appropriate method using Articaine Hydrochloride 4%.
- At the site a horizontal incision will be created, extending the entire length of the edentulous area, extending one tooth mesial and distal. Anterior and/or posterior vertical releasing incision will be made as needed.
- Full thickness mucoperiosteal flap will be raised with complete exposure of the alveolar bone.
- Bone width will be reconfirmed intrasurgically using a bone caliper. Measurements will be taken at around 1 mm below the crestal margin, to the nearest 0.5mm. Alveolar ridge width measurements will be repeated at second stage surgery.
- A.For the intervention:
- Drilling of bone will commence using the Pilot Drill to the desired depth (Drill speed 800-1500 rpm with copious irrigation).
- Osseodensification drilling will begin with the narrowest Densah Bur. (Counterclockwise drill speed 800-1500 rpm with copious irrigation). If when running the bur into the osteotomy a feeling of haptic feedback of pushing up and out of the osteotomy, repetitively lifting off and reapplying pressure with a pumping motion will be applied until the desired depth is reached.
- Densah Burs will be used sequentially in small increments. As the bur diameter increases, the bone will slowly expand to the final diameter.
- The osteotomy final preparation diameter would be an average diameter that measures 0.5-0.8 mm smaller than the implant average diameter in soft bone, and In hard bone, diameter that measures 0.2-0.5 mm smaller than the implant average diameter.
- Implant placement using the drill motor initially, then Finishing placement of the implant to depth with a torque-indicating wrench.
- If < 1mm of buccal bone thickness has resulted after osseodensification, bone grafting post implant placement and complete implant coverage will be considered
5.B.For the control:
- A bone crestal incision will be created, using the piezo-electric surgical tips. The cut will be done through the cortical bone to reach the trabecular bone.
- One/two vertical cuts will be created by piezo-drill as needed connecting, to the crestal cut.
- Conventional Drills will be used for osteotomy preparation by wedging it between the two plates of bone.
- The implant with the proper length and diameter will be gradually engaged to separate the buccal and Lingual/palatal bone until full seating is achieved.
- Cover screws will be placed on the implants. 7.Closure of the flap will be done by interrupted sutures using 4-0 resorbable suture materials. III. Post-operative phase: Post-operative instructions and medication: Patient is recommended to:
- Maintain a soft diet to avoid trauma to the surgical site.
- Place a cold compress superficially on the skin overlying the surgical site immediately. Apply for 30 minutes, then off for 20-30 minutes. This should be done on a near continuous basis (or as much as possible) for the first 48 hours.
- Maintain Oral hygiene but avoid surgical site for the first 4 days after surgery.
- Medications (Ferrigno et al. 2005)( Garcez-Filho et al.2015) • Augmentin* (1g tablets) will be prescribed twice daily for 5 days to avoid possibility of infection.
- Ibuprofen** 600mg four times daily for one week.
- Voltarene*** (75 mg injection I.M.) will be used in case of severe pain, as a rescue.
- Hexitol**** 0.12% chlorhexidine mouth rinse for 2 weeks.
- Sutures will be removed after 2 weeks
- Final restoration will be completed after 6 months
- Augmentin 1g. Medical union pharmaceuticals co. Abu Sultan, Ismailia, Egypt. **BRUFEN 600 (Ibuprofen 600 mg). Kahira Pharm. \& Chem. Ind. Co., Under licence from: Abbott Laboratories.
- Voltarene® 75mg/3ml (IM). Diclofenac natrium. NOVARTIS PHARMA. S.A.E.
- Hexitol Chlorhexidine Hcl 125 mg / 100 ml. Arab Drug Company (ADCO).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double Blinded, Parallel group, Randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Ridge expansion by osseodensification | Experimental | Procedure: Ridge Expansion by ossedensificationRidge expansion and osteotomy drilling by osseodensification in conjunction with simultaneous implant placement in narrow ridges. |
| Ridge expansion by ridge splitting | Active comparator | Procedure: ridge expansion by ridge splittingRidge expansion by ridge splitting using the piezotome in conjunction with simultaneous implant placement in narrow ridges. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with at least one missing tooth in need of replacement.
- Patients having a Bucco-lingual/palatal width of the edentulous alveolar ridge less than 6 mm with a minimum of 3mm residual bone width.
- Patients having at least 11 mm residual bone height at the proposed edentulous area.
- The recipient bed of the implant should be free from any pathological conditions.
- No history of diagnosed bone disease or medication known to affect bone metabolism.
Key exclusion criteria (9 listed)
- Patients incapable to undergoing minor oral surgical procedures.
- Patients with insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.
- Patients who have any systemic condition that may contraindicate implant therapy.
- Patients with modifying habits affecting osteointegration for example, smoking and alcoholism.
- Patients with parafunctional habits that can overload the implant, such as bruxism and clenching.
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 Expansion by ossedensificationOsseodensification is a new concept facilitated by Densah® Burs which are a multi- fluted osteotome like drilling instrumentsThe idea behind the technique is using a non-subtractive drilling mode that preserves bone and increases its density along the osteotomy walls instead of cutting it away (Huwais and Meyer 2015) | Procedure or surgery | Ridge expansion by osseodensification |
| ridge expansion by ridge splittingusing the piezotome,Piezoelectric ridge splitting allows exact, clean, and smooth even curved cutting of the bone tissue, with proper visibility. | Procedure or surgery | Ridge expansion by ridge splitting |
Primary outcome
Change in bone width
Time frame: Baseline and six month post surgically
Using Cone beam computed tomography bone width gain will be reported in millimeters.
5 secondary outcomes
Change in Implant stability Quotients
Time frame: at the time of surgery and 6 month post surgical
soft tissue healing at 1 week using the Healing index by Landry,Turnbull and Howley (1988) to describe the extent of clinical healing after periodontal surgery.
Time frame: 1 week post surgically.
soft tissue healing at 2 weeks using the Healing index by Landry,Turnbull and Howley 1988 to describe the extent of clinical healing after periodontal surgery.
Time frame: 2 weeks post surgically
Changes in Crestal Bone level
Time frame: at the time of enrollment and 6 month post surgically
Pain scale using the numerical Visual analog scale.
Time frame: 1 week post surgically
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 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.
Radwa A ElMaghrabi, BSC principal investigator
Cairo University
Amr zahran, PHD study director
Cairo University
Ahmed Al barbary, PHD study chair
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 Ridge Expansion by ossedensification and ridge expansion by ridge splitting in people with Alveolar Ridge Augmentation, 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 6 inclusion and 9 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 31 Jul 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 Radwa A ELMaghrabi, BCS (00201018626244, Radwaelmaghrabi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone width (time frame: Baseline and six month post surgically). 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 31 Jul 2018.