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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03065803
Other study ID # Dental socket preservation
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 11, 2017
Last updated February 22, 2017
Start date March 1, 2017
Est. completion date May 1, 2018

Study information

Verified date February 2017
Source Cairo University
Contact Passant Khaled
Phone 20201005533777
Email dr.passant.khaled@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date May 1, 2018
Est. primary completion date January 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Buccal plate expansion technique for 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).
Guided bone regeneration technique for post-extraction dental socket preservation
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)

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Passant Khaled Tayaa Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03735199 - 3D Printed Scaffold Device for Ridge Preservation After Tooth Extraction N/A