- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07589426
Horizontal Ridge Augmentation in Maxillary Esthetic Zone Using Bovine Bone Graft Versus Extended Sticky Bone With Simultaneous Implant Placement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patient selection This study will involve sixteen implants inserted in patients with missing upper tooth / teeth in the esthetic zone accompanied by horizontal alveolar ridge resorption, seeking future tooth replacement. The patients will be selected from the Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University
Inclusion Criteria:
- Patient aged 18-45 years.
- Cooperative patient with high motivation and acceptable oral hygiene.
- Maxillary narrow ridge in the esthetic zone that needed horizontal bone augmentation. (Class I Siebert classification). (22)
- No deep undercut at the ridge in the buccal aspect.
- The presence of enough keratinized gingiva(≥3mm).(23)
- Sufficient inter-arch space to accommodate the future prosthesis. (24)
- Patients able to comply with the required recall visits.
Exclusion criteria:
- Local and / or systemic conditions that contraindicate the placement of dental implant or surgery
- Smokers
- Pregnancy.
- Parafunctional habits, including bruxism and clenching.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Al Mansurah, Egypt
- Mansoura University
-
Al Mansurah, Egypt
- Amira Attia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient aged 18-45 years, Cooperative patient with high motivation and acceptable oral hygiene, maxillary narrow ridge in the esthetic zone that needed horizontal bone augmentation. (Class I Siebert classification) (24),No deep undercut at the ridge in the buccal aspect, The presence of enough keratinized gingiva(≥3mm).(25), sufficient inter-arch space to accommodate the future prosthesis. (26) , and Patients able to comply with the required recall visits.
Exclusion Criteria:
- Local and / or systemic conditions that contraindicate the placement of dental implant or surgery, smokers, pregnancy and parafunctional habits, including bruxism and clenching.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Eight dental implants were inserted simultaneously with horizontal ridge augmentation using Medpark
For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site.
For group II, extended sticky bone (ESB) was prepared by centrifugation of autologous blood followed by preparation of ALB-PRF and mixing with bone particulates (50:50 allograft: xenograft) to obtain the final graft materia
|
The oral cavity was prepared using 0.12% chlorhexidine mouth rinse for one minute. Local anesthesia was administered using articaine 4% with 1:100,000 epinephrine. A full-thickness mucoperiosteal flap was reflected using a crestal horizontal incision with vertical releasing incisions to expose the surgical site. Osteotomy preparation was performed using a pilot drill to the planned depth at 800-850 rpm under copious sterile saline irrigation, followed by sequential drilling according to the manufacturer's protocol until the final implant size was achieved. The sterile implant was then inserted using a ratchet wrench. Implant stability was immediately assessed using resonance frequency analysis (Osstell device), and cover screws were subsequently placed. For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site. For group II, extended sticky bone (ESB) was prepared b The oral cavity was prepared using 0.12% chlorhexidine mouth rinse for one minute. Local anesthesia was administered using articaine 4% with 1:100,000 epinephrine. A full-thickness mucoperiosteal flap was reflected using a crestal horizontal incision with vertical releasing incisions to expose the surgical site. Osteotomy preparation was performed using a pilot drill to the planned depth at 800-850 rpm under copious sterile saline irrigation, followed by sequential drilling according to the manufacturer's protocol until the final implant size was achieved. The sterile implant was then inserted using a ratchet wrench. (Fig.1B & Fig.2B) Implant stability was immediately assessed using resonance frequency analysis (Osstell device), and cover screws were subsequently placed. For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site. For group II, extended sticky bone (ESB) was prepared b |
|
Experimental: Eight dental implants were inserted simultaneously with horizontal ridge augmentation using extended
|
The oral cavity was prepared using 0.12% chlorhexidine mouth rinse for one minute. Local anesthesia was administered using articaine 4% with 1:100,000 epinephrine. A full-thickness mucoperiosteal flap was reflected using a crestal horizontal incision with vertical releasing incisions to expose the surgical site. Osteotomy preparation was performed using a pilot drill to the planned depth at 800-850 rpm under copious sterile saline irrigation, followed by sequential drilling according to the manufacturer's protocol until the final implant size was achieved. The sterile implant was then inserted using a ratchet wrench. Implant stability was immediately assessed using resonance frequency analysis (Osstell device), and cover screws were subsequently placed. For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site. For group II, extended sticky bone (ESB) was prepared b The oral cavity was prepared using 0.12% chlorhexidine mouth rinse for one minute. Local anesthesia was administered using articaine 4% with 1:100,000 epinephrine. A full-thickness mucoperiosteal flap was reflected using a crestal horizontal incision with vertical releasing incisions to expose the surgical site. Osteotomy preparation was performed using a pilot drill to the planned depth at 800-850 rpm under copious sterile saline irrigation, followed by sequential drilling according to the manufacturer's protocol until the final implant size was achieved. The sterile implant was then inserted using a ratchet wrench. (Fig.1B & Fig.2B) Implant stability was immediately assessed using resonance frequency analysis (Osstell device), and cover screws were subsequently placed. For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site. For group II, extended sticky bone (ESB) was prepared b |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant Stability Quotient (ISQ) Values Assessed by Resonance Frequency Analysis
Time Frame: Baseline and 6 months after implant placement
|
Implant stability was assessed using resonance frequency analysis (RFA) with the Osstell device and expressed as Implant Stability Quotient (ISQ) values. ISQ scores range from 1 to 100, with higher scores indicating greater implant stability and osseointegration. High stability: ISQ > 70 Medium stability: ISQ 60-69 Low stability: ISQ < 60 Measurements were recorded immediately after implant placement and at the 6-month follow-up. |
Baseline and 6 months after implant placement
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ms.25.04.21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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