Clinical trial NCT04679766: Evaluation of Ice Cream Cone Technique With Immediate Implant Placement in Patients With Labial Plate Dehiscence
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implant
Guided Bone Regeneration
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in buccal/labial vertical bone dimensions
timeFrame: 6 months post operative
Secondary outcomes:
measure: Changes in labial/buccal plate thickness
timeFrame: 6 months
measure: Keratinized tissue width
timeFrame: 6 months
measure: Gingival thickness
timeFrame: 6 months
measure: Post operative pain measured with VAS scale
timeFrame: 1 week -2 weeks
measure: Post-operative patient satisfaction with Yes or No question
timeFrame: 6 months
Other outcomes:
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