Evaluation of Ice Cream Cone Technique With Immediate Implant Placement in Patients With Labial Plate Dehiscence

NCT04679766 | Unknown

• 1 other identifier: MAmagad
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Immediate tooth replacement with immediate implants into fresh extraction sockets has become a common and promising clinical procedure in daily practice in regard of implant survival, osseointegration and esthetic outcomes . However, there are some challenges encountered in the treatment of patients with labial bone plate dehiscence. Deficiency of facial bone anatomy has a negative impact on esthetics and is a critical causative factor for esthetic implant complications and failures .. Few studies investigated the reconstitution of labial bone plate dehiscence using ice cream cone technique and their results showed adequate bone regeneration 4 to 6 months where no labial plate was present prior to grafting technique. Ice cream cone technique as a flapless grafting technique in conjunction with immediate implant placement in patients with labial bone plate dehiscence requires further studies for its clinical relevance and approval.

Conditions

Dental Implant; Guided Bone Regeneration

Outcome Measures

Primary Outcomes (1)

• Changes in buccal/labial vertical bone dimensions

  Vertical bone dimension will be measured at day 0 and 6 months post-operative

  6 months post operative

Secondary Outcomes (5)

• Changes in labial/buccal plate thickness

  6 months

• Keratinized tissue width

  6 months

• Gingival thickness

  6 months

• Post operative pain measured with VAS scale

  1 week -2 weeks

• Post-operative patient satisfaction with Yes or No question

  6 months

Study Arms (1)

Patients with non-restorable tooth in maxillary bi-cuspid region with labial/buccal plate dehiscence

EXPERIMENTAL

Procedure: Ice cream cone technique with immediate implant as a flapless bone regenerative method in management of patients with labial plte dehiscence

Interventions

Ice cream cone technique with immediate implant as a flapless bone regenerative method in management of patients with labial plte dehiscence PROCEDURE

Atraumatic extraction will be done The extraction socket will be debrided to remove any residual debris using surgical curettes Socket walls will be checked using a periodontal probe to ensure integrity of all sockets walls except the labial bone plate which must show a dehiscence. Implant placement will be done. All implants will engage at least 3 mm apical to the apical end of the socket with adequate primary stability Resorbable collagen membrane will be cut confirming to the size and shape of the defect of labial bone plate dehiscence. The membrane will be placed against internal surface of the extraction socket against the remaining buccal plate of bone. The gap between the collagen membrane and the implant fixture will be filled with xenograft particulates.The membrane will be folded in palatal direction to seal the socket in an ice cream cone shape, then will be secured using non-resorbable sutures

Patients with non-restorable tooth in maxillary bi-cuspid region with labial/buccal plate dehiscence

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-restorable teeth in maxillary inter-bicuspid region.
• All teeth have labial plate dehiscence (socket type II) after extraction.
• Patients free from any systemic conditions that may affect healing.
• Adequate bone volume for the placement of immediate implant.
• Presence of the adjacent teeth.
• Compliant patients.

You may not qualify if:

• Smokers.
• Pregnant females.
• Patients who were taking or currently taking any of the bisphosphonates.
• Any disease that might affect bone metabolism as osteoporosis.
• Insufficient inter-occlusal distance or mesio-distal space to place an implant supported restoration.
• The presence of any signs of acute infection in the surgical site or the adjacent natural teeth.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 22, 2020
• Study Start: January 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After completion of the study
• Access Criteria: Clinicaltrials.gov