Hard and Soft Tissue Changes Following Vestibular Socket Preservation Versus Ice Cream Cone Technique for Management of Defective Fresh Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial

Not Applicable

Not yet recruiting

• Conditions: Alveolar Ridge Preservation
• Interventions: Procedure: Control Group ice cream cone technique; Procedure: Intervention group Vestibular Socket Preservation

• Registration Number: NCT06435754
• Lead Sponsor: Cairo University

Brief Summary

Evaluation of hard and soft tissue changes following vestibular socket preservation versus ice cream cone technique for management of defective fresh extraction sockets in the esthetic zone.

Detailed Description

The aim of this randomized clinical trial is to assess the volumetric and radiographic ridge contour changes following alveolar ridge preservation using Vestibular socket preservation in patient with type II fresh extraction sockets, versus ice cream cone technique.

In patients needing extraction in anterior maxilla with type II sockets, there will be no difference between the Vestibular socket preservation and ice cream cone technique regarding the changes in alveolar ridge contour.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-05-24
• Study First Posted: 2024-05-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-14
• Last Update Posted: 2024-07-16
• Study Start: 2024-08
• Primary Completion: 2025-09
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adults from the age of 18 - 40 years
• Patients with non-restorable maxillary teeth/tooth indicated for extraction in the area from 2nd premolar to 2nd premolar
• Type II sockets will be selected as revealed by Cone beam computed tomography (CBCT).
• Intact gingival tissue with at least 2mm keratinized tissue
• Absence of any systemic disease or drugs that contraindicate oral surgery using Modified
• Cornell Medical Index .
• Patients accepts to provide informed consent

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Exclusion Criteria

• Pregnant and lactating females.
• Smokers as smoking is a contraindication for any plastic periodontal surgery.
• Patients with BOP>15%.
• Patients with periodontal diseases .
• Handicapped and mentally retarded patients.
• Patients undergoing radiotherapy.
• Presence of systemic disease that would affect wound healing.
• Presence of active infection with soft tissue communication.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group ice cream cone technique	Control Group ice cream cone technique	Alveolar ridge preservation following atraumatic extraction using ice cream cone technique.
Intervention group Vestibular Socket Preservation	Intervention group Vestibular Socket Preservation	Alveolar ridge preservation following atraumatic extraction using Vestibular Socket preservation.

Primary Outcome Measures

Name	Time	Method
Linear buccal distance (mm)	6 months	Soft tissue linear buccal distance will be measured using 3D scans via intaoral digital scanner at baseline, 3 months and 6 months using 3D software (NemoSmile Design 3D, Nemotec, Madrid, Spain) and STL viewer (3Shape Ortho viewer, 3Shape, Denmark)

Secondary Outcome Measures

Name	Time	Method
Labiopalatal volumetric ridge contour analysis (mm)	6 months	Labiopalatal volumetric ridge contour analysis will be measured using 3D scans via intaoral digital scanner at baseline, 3 months and 6 months using 3D software (NemoSmile Design 3D, Nemotec, Madrid, Spain) and STL viewer (3Shape Ortho viewer, 3Shape, Denmark) and scans will be superimposed on each other.
Changes in the height of the socket buccal and palatal ridges (mm)	6 months	Radiographic assessment using Cone Beam Computed Tomography to assess the labiopalatal alveolar ridge width reduction and changes in the height of the socket buccal and lingual ridges. Cone Beam Computed Tomography (CBCT) (Carestream Health, CS 8100 3D System) will be performed preoperative, baseline and 6 months postoperative.
Patient satisfaction (Yes/No)	2 weeks	Patient satisfaction will be evaluated using questionnaires during the 2 weeks after ARP.
Pain (1-10)	2 weeks	The severity of subjective pain and swelling will be evaluated using the visual analog scale (VAS) score (score range = 0-10, with 0 reflecting no pain and swelling), and durations of pain and swelling will be investigated during the 2 weeks after ARP