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

NCT ID: NCT06435754

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2025-11-30

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.

Conditions

Alveolar Ridge Preservation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group Vestibular Socket Preservation

Alveolar ridge preservation following atraumatic extraction using Vestibular Socket preservation.

Group Type: EXPERIMENTAL

Intervention group Vestibular Socket Preservation

Intervention Type: 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.

Control group ice cream cone technique

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

Group Type: ACTIVE_COMPARATOR

Control Group ice cream cone technique

Intervention Type: 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

Interventions

Intervention group Vestibular Socket Preservation

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 Type: PROCEDURE

Control Group ice cream cone technique

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Norai Ahmed Mohamed Zayed

Dentist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Norai Zayed, Masters

Role: CONTACT

norai.zayed@dentistry.cu.edu.eg

01221444954

Other Identifiers

4424

Identifier Type: -

Identifier Source: org_study_id