Back to resultsBuccal Bone Resorption in Immediate Implants in Thin and Thick Buccal Plates of Bone in Esthetic Zone
Primary Purpose
Buccal Bone Thickness
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
immediate implant placement
Sponsored by
About this trial
This is an interventional other trial for Buccal Bone Thickness
Eligibility Criteria
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
Sites / Locations
- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
thin buccal bone
≥1 buccal bone
Arm Description
immediate implant placement in thin buccal bone wall socket
immediate implant placement in 1 mm or more buccal bone thickness socket
Outcomes
Primary Outcome Measures
buccal bone thickness
measurement of buccal bone thickness by a specially designed device and cone-beam computed tomography (CBCT) analysis
Secondary Outcome Measures
pink esthetic score (PES)
to assess esthetics, the score is from 0-14 0 being worst , 14 being best.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04630665
Brief Title
Buccal Bone Resorption in Immediate Implants in Thin and Thick Buccal Plates of Bone in Esthetic Zone
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Buccal Bone Thickness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
thin buccal bone
Arm Type
Other
Arm Description
immediate implant placement in thin buccal bone wall socket
Arm Title
≥1 buccal bone
Arm Type
Other
Arm Description
immediate implant placement in 1 mm or more buccal bone thickness socket
Intervention Type
Other
Intervention Name(s)
immediate implant placement
Intervention Description
immediate implant placement in thin and thick buccal bony plates
Primary Outcome Measure Information:
Title
buccal bone thickness
Description
measurement of buccal bone thickness by a specially designed device and cone-beam computed tomography (CBCT) analysis
Time Frame
1 year
Secondary Outcome Measure Information:
Title
pink esthetic score (PES)
Description
to assess esthetics, the score is from 0-14 0 being worst , 14 being best.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzy N Naiem
Phone
+201224785645
Email
suzy.naiem@gmail.com
Facility Information:
Facility Name
Cairo University
City
Cairo
State/Province
Greater Cairo
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hani El Nahass, PHD
Phone
+201000252603
Email
hani.elnahass@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26749417
Citation
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.
Results Reference
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PubMed Identifier
24450845
Citation
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.
Results Reference
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Buccal Bone Resorption in Immediate Implants in Thin and Thick Buccal Plates of Bone in Esthetic Zone
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