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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorCairo University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant and lactating females.

Smokers as smoking is a contraindication for any plastic periodontal surgery.

Patients with BOP>15%.

Patients with periodontal diseases .

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention group Vestibular Socket Preservation

    Procedure/Surgery

    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/Surgery

    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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Intervention group Vestibular Socket PreservationExperimental treatment 1 intervention
Group B: Control group ice cream cone techniqueActive comparator 1 intervention

Trial outcomes

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)

Time frame
6 months

Secondary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
6 months
3

Patient satisfaction (Yes/No)

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

Time frame
2 weeks
4

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

Time frame
2 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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