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NCT Number: NCT06435754

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.

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Key information

Conditions

Alveolar Ridge Preservation

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Linear buccal distance (mm)

    Time frame: 6 months

    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)

Secondary outcomes

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

    Time frame: 6 months

    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.

  2. Labiopalatal volumetric ridge contour analysis (mm)

    Time frame: 6 months

    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.

  3. Patient satisfaction (Yes/No)

    Time frame: 2 weeks

    Patient satisfaction will be evaluated using questionnaires during the 2 weeks after ARP.

  4. Pain (1-10)

    Time frame: 2 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Norai Zayed, Masters

CONTACT

[email protected]

01221444954

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 30, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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