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
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
Introduction and evaluation of a new technique for socket preservation involving internal expansion of the buccal plate of the extraction socket using internal flapless corticotomy and bone grafting the extraction socket with application of bioresorbable membrane biomaterials in comparison with the conventional guided bone regeneration technique for a conventional socket preservation method hoping to maintain or improve hard and soft tissue contour of the alveolar ridge post tooth extraction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2017
CompletedFirst Posted
Study publicly available on registry
February 28, 2017
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedFebruary 28, 2017
February 1, 2017
10 months
February 11, 2017
February 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
measuring horizontal and vertical bone dimensions 4 months after the surgical intervention.
measuring the horizontal and vertical bone loss after socket preservation using cone beam computed tomography (CBCT).
4 months
Study Arms (2)
Buccal plate expansion technique in dental socket preservation
ACTIVE COMPARATORAn 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).
Guided Bone regeneration technique for socket preservation
OTHEROn 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).
Interventions
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).
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Passant Khaled Tayaalead
- Cairo Universitycollaborator
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical professor
Study Record Dates
First Submitted
February 11, 2017
First Posted
February 28, 2017
Study Start
March 1, 2017
Primary Completion
January 1, 2018
Study Completion
May 1, 2018
Last Updated
February 28, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will share
the data will be available for other scientists after the end of the study on www.clinicaltrials.gov , all data will be shared except patient contact or private data