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

NCT06590168 | Completed

• 1 other identifier: AAN.2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Socket Shield; Socket Preservation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in the height of the socket buccal and palatal ridges (mm)

  6 months

• Labiopalatal volumetric ridge contour analysis (mm)

  6 months

• Patient satisfaction (Yes/No)

  2 weeks

• Pain (1-10)

  2 weeks

Study Arms (2)

intervention Vestibular Socket Preservation for socket preservation

EXPERIMENTAL

Procedure: Socket Preservation by vestibular socket therapy

ice cream cone technique for socket preservation

ACTIVE COMPARATOR

Procedure: Socket Preservation by icecream cone technique

Interventions

Socket Preservation by vestibular socket therapy PROCEDURE

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.

intervention Vestibular Socket Preservation for socket preservation

Socket Preservation by icecream cone technique PROCEDURE

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

ice cream cone technique for socket preservation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Giza Governorate, 4240101, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Periodontology, Cairo University

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: July 15, 2024
• Primary Completion: March 15, 2025
• Study Completion: April 1, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

EG (1)