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

NCT06435754 | Not Yet Recruiting DMC

• 1 other identifier: 4424
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Alveolar Ridge 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 group Vestibular Socket Preservation

EXPERIMENTAL

Alveolar ridge preservation following atraumatic extraction using Vestibular Socket preservation.

Procedure: Intervention group Vestibular Socket Preservation

Control group ice cream cone technique

ACTIVE COMPARATOR

Alveolar ridge preservation following atraumatic extraction using ice cream cone technique.

Procedure: Control Group ice cream cone technique

Interventions

Intervention group Vestibular Socket Preservation PROCEDURE

After atraumatic extraction Vestibular access horizontal incision will be made at the socket site, at the mucco-buccal fold. 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 group Vestibular Socket Preservation

Control Group ice cream cone technique PROCEDURE

After atraumatic extraction 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

Control group ice cream cone technique

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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

Central Study Contacts

Norai Zayed, Masters

CONTACT

01221444954; norai.zayed@dentistry.cu.edu.eg

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: Dentist

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 30, 2024
• Study Start: August 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07