Hard and Soft Tissue Changes Following Vestibular Socket Preservation Versus Ice Cream Cone Technique for Management of Defective Fresh Extraction Sockets

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

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.

Study Overview

• Status: Completed
• Conditions: Socket Preservation; Socket Shield
• Intervention / Treatment: Procedure: Socket Preservation by vestibular socket therapy; Procedure: Socket Preservation by icecream cone technique

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 4240101
      • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Adults from the age of 18 - 60 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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention Vestibular Socket Preservation for socket preservation	Procedure: Socket Preservation by vestibular socket therapy; Subperiosteal tunnel will be created from the facial aspect of the socket orifice and extending apically until the extent of the vestibular access incision. A cortical shield will be introduced from the vestibular incision through the tunnel and the Socket will be filled by xenograft . Apical cut will be made at the palatal aspect to free the pedicle flap connective tissue and the pedicle flap will be raised using periosteal elevator and rotated and rolled occlusally to seal the socket and sutured using interrupted sutures . The primary palatal flap will be sutured in place over the donor site palatally using interrupted sutures.
Active Comparator: ice cream cone technique for socket preservation	Procedure: Socket Preservation by icecream cone technique; Collagen barrier membrane will be shaped as an ice cream cone and placed in the extraction socket lining the buccal tissues. The socket will be filled with Demineralized Bovine Bone Matrix DBBM.The upper part of the membrane will be used to cover the socket and will be stabilized by interrupted sutures using prolene sutures of size 6-0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Linear buccal distance (mm)	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)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the height of the socket buccal and palatal ridges (mm)	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.	6 months
Labiopalatal volumetric ridge contour analysis (mm)	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.	6 months
Patient satisfaction (Yes/No)	Patient satisfaction will be evaluated using questionnaires during the 2 weeks after ARP.	2 weeks
Pain (1-10)	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	2 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Actual): March 15, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 6, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: AAN.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No