- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04630665
Buccal Bone Resorption in Immediate Implants in Thin and Thick Buccal Plates of Bone in Esthetic Zone
Clinical Assessment of Buccal Bone Resorption in Immediate Implants in Thin and Thick Buccal Plates of Bone and Its Implication on Esthetics. A Controlled Clinical Trial
To achieve esthetic immediate implants a minimum of adequate buccal bone thickness must be present. It was postulated that 2 mm of buccal bone thickness was needed to prevent recession of the buccal plate. However, this was reduced to 1 mm with more ongoing research. In a recent study postulated that a buccal bone thickness less than 1 mm could be sufficient.
Scarce literature was found that monitored the ridge alterations following implant placement.
In regards to the controversies regarding the minimal initial buccal bone thickness required to perform immediate implant placement, our study aims to monitor the buccal bone thickness and soft tissue changes over a year from implant and prosthetic placement.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Greater Cairo
-
Cairo, Greater Cairo, Egypt, 12613
- Cairo university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects who have at least one unrestorable tooth in the esthetic zone that needs to be extracted.
- Subjects with healthy systemic condition.
- Availability of bone apical and palatal to the socket to provide primary stability.
Exclusion Criteria:
- Patients with signs of acute infection related to the area of interest.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits.
- Smokers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: thin buccal bone
immediate implant placement in thin buccal bone wall socket
|
immediate implant placement in thin and thick buccal bony plates
|
|
Other: ≥1 buccal bone
immediate implant placement in 1 mm or more buccal bone thickness socket
|
immediate implant placement in thin and thick buccal bony plates
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
buccal bone thickness
Time Frame: 1 year
|
measurement of buccal bone thickness by a specially designed device and cone-beam computed tomography (CBCT) analysis
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pink esthetic score (PES)
Time Frame: 1 year
|
to assess esthetics, the score is from 0-14 0 being worst , 14 being best.
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Merheb J, Vercruyssen M, Coucke W, Beckers L, Teughels W, Quirynen M. The fate of buccal bone around dental implants. A 12-month postloading follow-up study. Clin Oral Implants Res. 2017 Jan;28(1):103-108. doi: 10.1111/clr.12767. Epub 2016 Jan 8.
- El Nahass H, N Naiem S. Analysis of the dimensions of the labial bone wall in the anterior maxilla: a cone-beam computed tomography study. Clin Oral Implants Res. 2015 Apr;26(4):e57-e61. doi: 10.1111/clr.12332. Epub 2014 Jan 23.
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21 Dec 2018 Protocol
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- SAP
- ICF
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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