Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
I. Pre-operative phase:
Clinical Examination:
Radiographic Examination:
A panoramic radiograph for screening purposes:
Cone beam computed Tomography (CBCT) for Diagnostic purposes:
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:
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.
6. 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ridge expansion by osseodensification | Experimental | Ridge expansion and osteotomy drilling by osseodensification in conjunction with simultaneous implant placement in narrow ridges. |
|
| Ridge expansion by ridge splitting | Active Comparator | Ridge expansion by ridge splitting using the piezotome in conjunction with simultaneous implant placement in narrow ridges. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ridge Expansion by ossedensification | Procedure | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in bone width | Using Cone beam computed tomography bone width gain will be reported in millimeters. | Baseline and six month post surgically |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at the time of surgery and 6 month post surgical |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radwa A ELMaghrabi, BCS | Contact | 00201018626244 | Radwaelmaghrabi@gmail.com | |
| Amr Zahran, PHD | Contact | 00201018626244 | dramrzahran@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Radwa A ElMaghrabi, BSC | Cairo University | Principal Investigator |
| Amr zahran, PHD | Cairo University | Study Director |
| Ahmed Al barbary, PHD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Faculty of Dentistry -Cairo University | Cairo | Egypt |
Not provided
Double Blinded, Parallel group, Randomized controlled trial.
Not provided
Not provided
Not provided
|
| ridge expansion by ridge splitting | Procedure | using the piezotome,Piezoelectric ridge splitting allows exact, clean, and smooth even curved cutting of the bone tissue, with proper visibility. |
|
| 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. | 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. | 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. | 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). | 1 week post surgically |
| Cairo University |
| Study Chair |