Immediate Implant Placement Using Immediate Dentoalveolar Restoration Versus Ice Cream Cone Technique With Labial Plate Dehiscence

NCT05946954 | Unknown DMC

• 1 other identifier: 2623
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

: Evaluation of Soft and Hard Tissue Changes following Immediate Implant using Immediate Dentoalveolar Restoration Versus Ice Cream Cone technique for management of Cases With Labial Plate Dehiscence

Conditions

Immediate Implant

Outcome Measures

Primary Outcomes (1)

• Bucco/facial-palatal ridge thickness

  Impressions were taken with addition silicone before tooth extraction, after six months of implant placement (immediately after the placement of the definite crown) and 12 months after crown installation. Casts were then obtained with special gypsum stone type IV.Casts were measured by a dentist not involved in the study with a digital caliper. Three reference points were measured from the free gingival margin to the apex at the implant site and in the contralateral tooth: 1 mm, 3 mm and 6 mm

  1 year

Secondary Outcomes (11)

• Radiographic bucco-palatal bone changes

  1 year

• 3. Radiographic width of bone labial to the implant

  1 year

• Radiographic vertical bone changes

  1 year

• Esthetic evaluation (The pink esthetic score)

  1 year

• Implant stability

  6 months

Study Arms (2)

Intervention group Immediate Dentoalveolar Restoration

EXPERIMENTAL

* After applying anesthesia to the maxillary tuberosity, a full thickness crestal incision was made following the distal contour of the maxillary right second molar. This incision was followed by a palatal release incision to access the donor area. * The flap was raised in the tuberosity area Then, the bone graft was harvested from the underlying bone by using a 1 cm wide flat chisel and a surgical hammer. * The corticocancellous graft was manipulated using a rongeur to reproduce the shape of the peri-implant bone defect. * The graft was carefully inserted to the level of the implant platform Finally, a screw-retained resin provisional crown, relined over a polyetheretherketone (PEEK) anti-rotation abutment, was placed out of occlusion, establishing the ideal emergence profile to accommodate the soft tissues and to promote a thicker and more stable gingival tissue margin

Procedure: Immediate Dentoalveolar Restoration

Control group Ice cream cone technique

ACTIVE COMPARATOR

Ice cream cone technique 1. 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. 2. 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 resorbable sutures to prevent dislodgment of the blood clot and bone grafting material

Procedure: Ice cream cone technique

Interventions

Immediate Dentoalveolar Restoration PROCEDURE

Topical anesthesia will be administered using an infiltration technique. • Atraumatic extraction will be done with the aid of periotome and Luxators. • The extraction socket will be debrided to remove any residual debris or granulation tissue. •. 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 according to manufactures' instructions; drills will be used sequentially in a more palatal direction leaving a buccal jumping gap of at least 2mm. All implants will engage at least 3 mm apical to the apical end of the socket with adequate primary stability

Intervention group Immediate Dentoalveolar Restoration

Ice cream cone technique PROCEDURE

Topical anesthesia will be administered using an infiltration technique. • Atraumatic extraction will be done with the aid of periotome and Luxators. • The extraction socket will be debrided to remove any residual debris or granulation tissue. •. 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 according to manufactures' instructions; drills will be used sequentially in a more palatal direction leaving a buccal jumping gap of at least 2mm. All implants will engage at least 3 mm apical to the apical end of the socket with adequate primary stability

Control group Ice cream cone technique

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-restorable teeth in the esthetic zone with a defect of labial bone.
• Teeth with no acute inflammation.
• Patients are free from any systemic condition that may affect the healing.
• Availability of bone apical and palatal to the socket to provide primary stability
• Good oral health.
• Willingness to sign the informed consent form.

You may not qualify if:

• Heavy smoker (\> 10 cigarettes/day)
• Pregnant females
• Contraindication for Implant surgery.
• Patients with poor oral hygiene.
• Acute inflammation in the site of implantation and adjacent tissue.
• A history of radiotherapy in the head or neck region.
• Patients with systemic diseases like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation

Sponsors & Collaborators

• Aya Sharaf: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 14, 2023
• Study Start: October 1, 2023
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 7, 2023

Record last verified: 2023-09