- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03264053
Socket Shield Technique Versus Conventional Immediate Implant Placement in Thin Buccofacial Bone
September 14, 2017 updated by: Abdullah Abdou Mattar, Cairo University
Socket Shield Technique Versus Conventional Immediate Implant Placement in Thin Buccofacial Bone to Evaluate Buccal Bone Resorption: A Randomized Controlled Trial
Buccal bone is prone to resorb after tooth extraction specially with immediate tooth implantation which could compromise the esthetics of the patient.
socket shield technique retains the buccal aspect of the extracted root fragment which may help in preventing the buccal bone from resorbing and prevent esthetics deterioration
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The alveolar ridge resorbs and collapses following tooth removal which continues to be a major concern for practitioners.
Many researchers concluded that buccal aspect of the ridge is more prone to resorption, as it is primarily supplied by the periodontal tissues and ligments of the tooth.
Therefore, extraction of the hopeless tooth, may be a reason for buccal cortical plate resorbing at a faster rate than the palatal plate leading to its total degradation.
This may lead to dimensional changes in the human ridge and the aesthetic area is highly affected by this process.
Several techniques in the litreture were proposed to solve the problem of thin buccal bone resorption with or without immediate implantation in the aesthetic area.
Some of these techniques are the guided bone and soft tissue regenraton and bone augmentation but proved to be slight aggressive with high morbidity rate.
Recently, several papers were published concerning the socket shield technique explaining how to maintain the ridge width and height.
Socket shield technique that was first introduced in 2010 aids at retaining the buccal fragment of root in place and intact thus placing the implant behind the lingual aspect of that fragment so that the periodontal ligments and tissues preserve its vitality and aids in preventing the collapsing of the buccal bone.
This would help in improving aesthetics especially during immediate implant placment in the anterior maxillary region.
Study Type
Interventional
Enrollment (Anticipated)
86
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
-
-
-
Cairo, Egypt
- Recruiting
- Cairo University
-
Contact:
- Ahmad el khadem, lecturer
- Phone Number: 00201227520298
- Email: hassan.ahmed@dentistry.cu.edu.eg
-
-
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
20 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Humans
- Esthetic area (anterior and first premolars)
- Intact labial plate
- Hopeless tooth indicated for extraction and immediate implant placement
Exclusion Criteria:
• Implantation after trauma
- Peri-implantits defects
- Use of barrier membranes(GBR)
- Socket preservation
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: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: SOCKET SHIELD TECHNIQUE
Socket shield is the surgical removal of the frontal aspect of the badly broken root and retaining the lingual aspect so as to prevent crestal bone loss with insertion of the dental implant behind it
|
Socket shield is the Removal of the lingual portion of the anterior root thus retaining the lingual portion
Other Names:
|
|
ACTIVE_COMPARATOR: Conventional immediate implantation
Conventional immediate implantation is the surgical removal of the entire badly broken root
|
Conventional immediate implantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Buccal bone resorption assesed by cone beam computed tomography as a measuring tool
Time Frame: 12 months
|
Measuring buccal bone loss after the procedure comparing between leaving the buccal portion of the root and extracting the whole root
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abdullah A Mattar, A.Lecturer, Cairo University
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)
August 20, 2017
Primary Completion (ANTICIPATED)
August 20, 2018
Study Completion (ANTICIPATED)
December 1, 2018
Study Registration Dates
First Submitted
August 16, 2017
First Submitted That Met QC Criteria
August 24, 2017
First Posted (ACTUAL)
August 28, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 15, 2017
Last Update Submitted That Met QC Criteria
September 14, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- CEBD-CU-2017-08-03
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.
Clinical Trials on Crestal Bone Loss
-
Suez Canal UniversityNot yet recruiting
-
Ain Shams UniversityCompleted"Bony Changes Around Dental Implant in Free Fibular Graft Versus Non-Vascularized Iliac Crest Graft"Survival Rate | Crestal Bone LossEgypt
-
Cairo UniversityCompleted
-
Al-Mustansiriyah UniversityCompletedDental Implant | Crestal Bone Loss | Platelet Rich Fibrin | Keratinized MucosaIraq
-
Cairo UniversityCompleted
-
Søren JepsenCompletedInfluence of Platform-switching on Bone Level Alterations: a 3 Year Randomized Clinical Trial (RCT).Periimplant Crestal Bone Level Changes
-
Tel-Aviv Sourasky Medical CenterUnknownPreserve Crestal Bone Level and Gingival Margin Around Dental ImplantsIsrael
-
Azhar ALI ELSAYED SELEEMUnknownCrestal Bone Resorption | Implant Primary Stability | Implant Osseointegration
-
Cairo UniversityNot yet recruitingImmediate Implant | Autogenous Tooth Graft | Estetic Zone | Autogenous Bone Graft | Jumping Gap | Crestal Bone LevelEgypt
-
Cairo UniversityRecruitingBone Formation Around Implant After Crestal Sinus LiftingEgypt
Clinical Trials on Socket shield
-
Kafrelsheikh UniversityCompletedDental Implant Failed | Implant ComplicationEgypt
-
The First Affiliated Hospital of Guangzhou Medical...CompletedImmediate Dental Implant LoadingChina
-
Hams Hamed AbdelrahmanActive, not recruiting
-
Cairo UniversityUnknown
-
International Dental Contiuing EducationNot yet recruitingConnective Tissue Graft | Socket Shield Technique | Immediate Dental Implant PlacementEgypt
-
Kafrelsheikh UniversityNot yet recruitingDental Implant FailedEgypt
-
Cairo UniversityUnknownMarginal Bone Loss in Socket Shield TechniqueEgypt
-
Kafrelsheikh UniversityCompletedDental Implant Failed | Implant Site Reaction | Tooth Extraction Status NosEgypt
-
Egyptian Russian UniversityCompletedAlveolar Bone ResorptionEgypt
-
Kutahya Health Sciences UniversityCompleted