Ridge Expansion by Osseodensification Drilling Compared to Ridge Splitting Technique Simultaneously With Implant Placement in Narrow Alveolar Ridges: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in bone width
Study Overview
Brief 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, 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:
I. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •Patients in the growth stage with mixed dentition.
- •Patients with a history of drug abuse.
- •Patients with a history of psychiatric disorder.
Arms & Interventions
Ridge expansion by osseodensification
Ridge expansion and osteotomy drilling by osseodensification in conjunction with simultaneous implant placement in narrow ridges.
Intervention: Ridge Expansion by ossedensification (Procedure)
Ridge expansion by ridge splitting
Ridge expansion by ridge splitting using the piezotome in conjunction with simultaneous implant placement in narrow ridges.
Intervention: ridge expansion by ridge splitting (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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.(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.(2 weeks post surgically)
- Changes in Crestal Bone level(at the time of enrollment and 6 month post surgically)
- Pain scale using the numerical Visual analog scale.(1 week post surgically)
- Change in Implant stability Quotients(at the time of surgery and 6 month post surgical)
Investigators
Radwa Abdelhamid ElMaghrabi
Principal Investigator
Cairo University