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

Not Applicable

Not yet recruiting

• Conditions: Immediate Implant
• Interventions: Procedure: Immediate Dentoalveolar Restoration; Procedure: Ice cream cone technique

• Registration Number: NCT05946954
• Lead Sponsor: Aya Sharaf

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

Detailed Description

In patients with labial plate dehiscence in the esthetic zone, there is no difference between the use of Immediate Dentoalveolar Restoration Versus Ice Cream Cone technique in conjunction with immediate implant placement in enhancing the amount of bone labial to the implant

Study Timeline

• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-07
• Study First Posted: 2023-07-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-03
• Last Update Posted: 2023-09-07
• Study Start: 2023-10-01
• Primary Completion: 2025-10-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group Immediate Dentoalveolar Restoration	Immediate Dentoalveolar Restoration	* 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
Control group Ice cream cone technique	Ice cream cone technique	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

Primary Outcome Measures

Name	Time	Method
Bucco/facial-palatal ridge thickness	1 year	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

Secondary Outcome Measures

Name	Time	Method
Gingival Thickness	1 year	Gingival thickness will be evaluated 2 mm below the gingival margin with a short needle for and silicon disk stop. The needle will be inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface was reached. The silicone disc stop was then mounted in close contact with the gingival tissue surface. The insertion depth was assessed with a digital caliper accurate to the nearest 0.1 mm
Post-Operative Pain	7 days	Pain will be assessed post-surgically using the Visual Analogue Scale (VAS) with numbers from 0 to 10 score zero represented no pain while score 10 represented the worst pain imaginable
Width of the Keratinized Tissue	1 year	It will be evaluated from the gingival margin to the mucogingival junction (MGJ). The MGJ was assessed with roll technique
Radiographic bucco-palatal bone changes	1 year	The bucco-palatal width of the alveolar bone will be measured perpendicular to the long axis of the alveolar bone; the 3 measurements will be the coronal width (CW), middle width (MW), and apical width (AW). Each measurement will be recorded at different times
Radiographic vertical bone changes	1 year	Vertical bone height will be measured. Measurement will be taken at highest point of the remaining labial/buccal plate of bone using the implant neck as a reference point. Each measurement will be recorded at different times and the difference between pre and post-operative measurements will be determined as the gain in labial/buccal vertical bone dimension
3. Radiographic width of bone labial to the implant	1 year	Amount of bone labial to the implant will be measured perpendicular to the vertical line of the implant surface at the implant neck level or the top of the buccal bone (which is regarded as 0 mm), 3 mm and 6 mm apical to the implant neck Each measurement will be recorded at different times (at day 0 after finishing the procedure, 6 and 12 months post-operatively)
Implant stability	6 months	implant stability will be measured using Ostell which has a scale ranges from 1 to 100, the higher the ISQ the more stability
Midfacial recession	1 year	Corono-apical distance between the peri-implant soft tissue margin and the cemento-enamel junction (CEJ) of the homologous contralateral tooth
Post-Operative patient's Satisfaction	1 year	Three Yes or No Questions will be asked to the patient about his overall satisfaction about the procedure
Esthetic evaluation (The pink esthetic score)	1 year	The pink esthetic score will be calculated on the parameters defined by (Fürhauser et al. 2005). Clinical photographs will be taken to evaluate peri-implant soft tissue through evaluating seven variables compared to a natural reference tooth including: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft- tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14.
Post-operative swelling	7 days	Swelling will be assessed post-surgically using the Verbal Rating Scale (VRS) (García et al. 2008): * Absent (no swelling),; * Slight (intraoral swelling at the operated area),; * Moderate (moderate intraoral swelling at the operated area) and; * Intense (intensive extraoral swelling extending beyond the operated area)