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

Dental Implant Clinical Trial

Official title:

Evaluation of Ice Cream Cone Technique as a Flapless Guided Bone Regenerative Method With Immediate Implant Placement in Management of Patients With Labial Plate Dehiscence: A Case Series

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04679766
• Other study ID #: MAmagad
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: July 2021

Study information

• Verified date: December 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Classical methods of guided bone regenerative methods succeeded to partially reconstitute the lost labial plate of bone using different grafting materials with barrier membranes.

This might be attributed to the necessity of using a full mucoperiosteal flap which interrupts the vascular supply to the bone and jeopardizing the process of total facial bone regenerative process. Therefore, Tan-Chu et al., (2014) described in a case report an innovative technique using resorbable collagen membrane in the shape of ice cream cone and allograft in the reconstitution of labial plate in patients with socket type II after extraction with folding the membrane to seal the socket and containing the blood clot to allow for occupation of osteogenic cell population without raising a flap. This technique showed an adequate bone regeneration with net result of 1.32 mm prior to no labial plate present before grafting. Hence, using immediate implant placement with the conjunction of the ice cream cone technique in regeneration of labial plate of bone needs to be further assessed to evaluate its clinical outcomes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: July 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Non-restorable teeth in maxillary inter-bicuspid region.

2. All teeth have labial plate dehiscence (socket type II) after extraction.

3. Patients free from any systemic conditions that may affect healing.

4. Adequate bone volume for the placement of immediate implant.

5. Presence of the adjacent teeth.

6. Compliant patients.

Exclusion Criteria:

1. Smokers.

2. Pregnant females.

3. Patients who were taking or currently taking any of the bisphosphonates.

4. Any disease that might affect bone metabolism as osteoporosis.

5. Insufficient inter-occlusal distance or mesio-distal space to place an implant supported restoration.

6. The presence of any signs of acute infection in the surgical site or the adjacent natural teeth.

Related Conditions & MeSH terms

• Dental Implant
• Guided Bone Regeneration

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in labial/buccal plate thickness	Measured at day 0 and 6 months post-operative using Cone beam tomography	6 months
Secondary	Keratinized tissue width	Measured using william's graduated probe	6 months
Secondary	Gingival thickness	Measured using william's graduated probe	6 months
Secondary	Post operative pain measured with VAS scale	VAS scale from 0 to 10, where 0 no pain and 10 with highest pain	1 week -2 weeks
Secondary	Post-operative patient satisfaction with Yes or No question	Yes or No question of overall patient satisfaction of the procedure	6 months