- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03065803
Buccal Plate Expansion Technique Versus Guided Bone Regeneration Technique in Socket Preservation in the Aesthetic Zone.
Clinical Assessment of Buccal Plate Expansion Technique Versus Guided Bone Regeneration Technique in Socket Preservation in The Esthetic Zone: A Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Passant Khaled
- Phone Number: 20201005533777
- Email: dr.passant.khaled@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients requiring tooth extraction in the maxillary anterior teeth and premolars ranging to the second premolar.
- Cause of tooth extraction is due to caries, trauma or failed endodontic treatment.
- Only teeth with intact buccal bone plate will be considered for this study.
- Patients who are cooperative, motivated and hygiene conscious.
- Patients whose age is >18 years
Exclusion Criteria:
- Systemic conditions/disease that contraindicated surgery.
- Patients on drugs that may compromise bone healing.
- Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
- Smokers.
- Patients with Psychologic disorder.
- Pregnancy or lactation.
- Presence of acute periodontal or periapical pathology.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Buccal plate expansion technique in dental socket preservation
An internal osteotomy of the socket buccal plate will be performed with a piezotome (SurgyStar). Two vertical osteotomies and one horizontal osteotomy will be made to push the buccal plate outward from the socket. Two small cervical releasing incisions will be made in the mesiobuccal and distobuccal aspects of the socket to permit the displacement of the osteotomies in the area of keratinized tissue. The socket will be loaded with natural bovine bone mineral (cerabone). The biomaterial will be pressed to push the released buccal plate outward. A collagen bio absorbable membrane will be utilized to cover the socket. The collagen membrane plug will be stabilized on the top of the socket with a cross suture (silk 4/0). |
An internal osteotomy of the socket buccal plate will be performed with a piezotome (SurgyStar). Two vertical osteotomies and one horizontal osteotomy will be made to push the buccal plate outward from the socket. Two small cervical releasing incisions will be made in the mesiobuccal and distobuccal aspects of the socket to permit the displacement of the osteotomies in the area of keratinized tissue. The socket will be loaded with natural bovine bone mineral (cerabone). The biomaterial will be pressed to push the released buccal plate outward. A collagen bio absorbable membrane will be utilized to cover the socket. The collagen membrane plug will be stabilized on the top of the socket with a cross suture (silk 4/0).
Other Names:
|
OTHER: Guided Bone regeneration technique for socket preservation
On buccal side, two vertical incisions will be made at mesial and distal papilla of the adjoining teeth.
These incisions will be stretched out past mucogingival junction.
After full-thickness flap reflection on buccal and lingual sides, atraumatic tooth extraction utilizing periotome will be performed.
The periosteum of buccal flap will be incised; this would permit coronal advancement of facial flap and a tension-free primary closure.
Extraction sockets will be grafted with natural bovine bone mineral (cerabone).
Collagen membrane will be trimmed and placed on the grafted socket and alveolar bone.
Buccal and lingual/palatal flaps will be approximated utilizing interrupted simple loop and vertical mattress sutures (4/0) (Sadeghi et al., 2016).
|
After full-thickness flap reflection on buccal and lingual sides, atraumatic tooth extraction utilizing periotome will be performed.The periosteum of buccal flap will be incised; this would permit coronal advancement of facial flap and a tension-free primary closure.
Extraction sockets will be grafted with natural bovine bone mineral (cerabone).
Collagen membrane will be trimmed and placed on the grafted socket and alveolar bone.. Buccal and lingual/palatal flaps will be approximated utilizing interrupted simple loop and vertical mattress sutures (4/0)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measuring horizontal and vertical bone dimensions 4 months after the surgical intervention.
Time Frame: 4 months
|
measuring the horizontal and vertical bone loss after socket preservation using cone beam computed tomography (CBCT).
|
4 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
- Dental socket preservation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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