NCT03065803

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Status
unknown

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

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

February 11, 2017

Last Update Submit

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 COMPARATOR

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).

Procedure: Buccal plate expansion technique for dental socket preservation

Guided Bone regeneration technique for socket preservation

OTHER

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).

Procedure: Guided bone regeneration technique for post-extraction dental socket preservation

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).

Also known as: Internal corticotomy for buccal plate of bone in extraction socket for socket preservation
Buccal plate expansion technique in 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)

Guided Bone regeneration technique for socket preservation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

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