- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06274476
Prosthetic Rehabilitation of Thin Wiry Ridge by Ridge Splitting and Simultaneous Implants Placement (implant)
February 21, 2024 updated by: Sharaf Mohamed Yahia, Cairo University
Short-Term Evaluation of Prosthetic Rehabilitation of Thin Wiry Ridge by Ridge Splitting and Simultaneous Implants Placement: Non-randomized Control Trial
evaluates the success of prosthetic rehabilitation of thin wiry ridge and implants placed simultaneously in splitted ridge both clinically and radiographically.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
twenty-one participants were enrolled of which 13 patients (8 females and 5 males) were suffering from maxillary ridge atrophy and 8 patients (5 females and 3 males) had mandibular ridge atrophy; a total of 42 implants were performed using the ridge expansion technique.
The expansion was performed using the conventional disk technique, piezoelectric corticotomy, and self-threading expanders.
Implants were placed and loaded with fixed partial denture after 4 months for the mandible and 6 months for the maxilla.
Implant stability quotient (ISQ) was measured at T0 (implant placement) and TL (loading).
Crestal bone levels were measured at different times: T0, TL, and T12 (12 months).
Evaluation of prosthetic and surgical complications was carried out.
Data were analyzed and compared using analysis of variance and paired t-tests at a significance level of 5%.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sharkia
-
Zagazig, Sharkia, Egypt, 44715
- Mohamed yahia Sharaf
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- ridge of 2 to 4 mm of initial alveolar crest width
- bone height of at least 8 mm from vitastructures
good oral hygiene.
Exclusion Criteria:
patients who smoke more than 10 cigarettes per day diabetes mellitus, osteoporosis, and periodontal disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: maxillary atrophic ridge
received ridge splitting done by piezo surgery and implant placement in maxillary arch
|
ridge splitting piezo surgery and implant placement
Other Names:
|
|
Active Comparator: mandibular atrophic ridge
received ridge splitting done by saw technique using ridge expanders and implant placement in maxillary arch
|
ridge splitting piezo surgery and implant placement
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
implant success
Time Frame: 12 month
|
implant osseointgeration by radiographic evaluation .bone
loss by mm, and bone density
|
12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 9, 2018
Primary Completion (Actual)
December 9, 2019
Study Completion (Actual)
January 1, 2020
Study Registration Dates
First Submitted
February 15, 2024
First Submitted That Met QC Criteria
February 21, 2024
First Posted (Actual)
February 23, 2024
Study Record Updates
Last Update Posted (Actual)
February 23, 2024
Last Update Submitted That Met QC Criteria
February 21, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/9/9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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