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

Alveolar Ridge Preservation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06435754
• Other study ID #: 110589
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: November 2025

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: Norai Zayed, Masters
• Phone: 01221444954
• Email: norai.zayed[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Ridge Preservation

Intervention

Procedure:
• 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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Patient satisfaction (Yes/No)	Patient satisfaction will be evaluated using questionnaires during the 2 weeks after ARP.	2 weeks
Secondary	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