VST vs Modified Periosteal Inhibition Technique

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorTanta University

About this trial

Losing a tooth in the upper front of the mouth is common, and many people choose a dental implant to replace it. When a tooth is removed, the thin layer of bone in front of the socket - the buccal, or front, bone - often shrinks as the area heals. If this bone shrinks, the final implant can look less natural and the gum can recede. The problem is greater when part of the front bone is already missing at the time the tooth is taken out; this type of socket is harder to treat.

This study compares two surgical techniques that aim to protect the front bone and gum while a dental implant is placed on the same day the tooth is removed. In Vestibular Socket Therapy (VST), a thin bone membrane is inserted through a small incision high in the gum fold to cover the front bone, and bone graft material is packed into the socket. In Modified Periosteal Inhibition (MPI), a thin bone membrane is placed against the outside of the front bone and held in place with a tissue glue, and the socket is filled with a collagen sponge.

Adults aged 20 to 50 with a non-restorable upper front tooth (canine to canine) and partial loss of the front bone can take part. Participants are randomly assigned to one of the two techniques and receive an implant immediately after the tooth is removed, then are followed for 12 months. Using cone-beam CT scans, intraoral scans, and an esthetic (appearance) score taken at the start and at 6 and 12 months, the investigators measure the thickness of the front bone, the level and thickness of the gum around the implant, and the overall appearance.

The study tests whether one technique preserves or increases the thickness of the front bone and produces better gum and esthetic results than the other.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Medically compromised patients or systemic conditions precluding implant or periodontal surgery Smokers Pregnant or lactating women History of chemotherapy or head and/or neck radiotherapy Bisphosphonate therapy Uncontrolled diabetes

Trial design

Design model

Parallel

Treatments tested in this trial

  • VST

    Procedure/Surgery

    Immediate implant placement with Vestibular Socket Therapy. Following atraumatic extraction and socket debridement, a submucoperiosteal tunnel is prepared from the facial socket orifice to a vestibular access incision made 3-4 mm apical to the mucogingival junction. The implant is placed via a computer-guided surgical template (shoulder 3-4 mm apical to the labial gingival margin). A xenogenic cortical bone membrane is trimmed to the facial socket wall, inserted through the vestibular incision, and fixed with bone tacks; particulate xenograft is placed in the socket. The socket is sealed with a customized healing abutment and the vestibular incision closed with non-resorbable sutures.

  • Mucoperiosteal inhibition

    Procedure/Surgery

    Immediate implant placement with the Modified Periosteal Inhibition technique. Following atraumatic extraction and socket debridement, a conservative full-thickness flap is raised (extending one tooth mesial and distal), and the labial periosteum is detached from the labial bone plate. The implant is placed via a computer-guided surgical template (shoulder 3-4 mm apical to the labial gingival margin). A resorbable xenogenic bone membrane is inserted between the labial periosteum and the labial bone plate and fixed with cyanoacrylate tissue adhesive; a collagen sponge is placed in the socket. The socket is sealed with a customized healing abutment and the flap closed with non-resorbable sutures.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: VSTExperimental treatment 1 intervention
Group B: Modified Periosteal inhibitionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in facial (buccal) bone thickness

Facial bone thickness on the buccal aspect of the implant, measured in millimeters on cone-beam computed tomography (CBCT). Thickness is measured at standardized reference levels from the implant platform apically, and the change from baseline is calculated. A greater increase (or smaller reduction) indicates better preservation of the facial bone.

Time frame
6 months

Secondary outcomes

1

Change in peri-implant bone level (crest to apex)

Vertical peri-implant bone level measured in millimeters on CBCT from the implant platform to the first bone-to-implant contact, assessed from the crest apically; change from baseline is calculated. Less reduction indicates better crestal bone maintenance.

Time frame
6 months
2

Change in peri-implant mucosal level

Peri-implant mid-facial mucosal (soft-tissue) level measured in millimeters by superimposing intraoral scan (STL) files on the reference dataset; change from baseline is calculated. A more coronal position (less recession) indicates a more favorable soft-tissue outcome.

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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