NCT07784764

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2027

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 20, 2026

Last Update Submit

August 20, 2026

Conditions

Outcome Measures

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.

    6 months

Secondary Outcomes (2)

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

    6 months

  • Change in peri-implant mucosal level

    6 months

Study Arms (2)

VST

EXPERIMENTAL

Immediate implant placement combined with Vestibular Socket Therapy (VST). After atraumatic extraction of the non-restorable maxillary anterior tooth, the implant is placed with a computer-guided surgical template (shoulder 3-4 mm apical to the labial gingival margin). A xenogenic cortical bone membrane is inserted through a vestibular access incision to cover the facial bone plate and stabilized with bone tacks, particulate xenograft is placed in the socket, and the socket is sealed with a customized healing abutment.

Procedure: VST

Modified Periosteal inhibition

ACTIVE COMPARATOR

Immediate implant placement combined with the Modified Periosteal Inhibition (MPI) technique. After atraumatic extraction of the non-restorable maxillary anterior tooth, the implant is placed using a computer-guided surgical template (shoulder 3-4 mm apical to the labial gingival margin). A conservative full-thickness flap is raised, and a resorbable xenogenic bone membrane is placed between the labial periosteum and the labial bone plate, fixed with cyanoacrylate tissue adhesive; a collagen sponge is placed in the socket, and the socket is sealed with a customized healing abutment.

Procedure: Mucoperiosteal inhibition

Interventions

VSTPROCEDURE

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.

VST

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.

Modified Periosteal inhibition

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 20 to 50 years Non-restorable tooth in the maxillary anterior region (canine to canine) Elian Class II extraction socket (facial soft tissue present, buccal plate partially missing) confirmed on cone-beam computed tomography (CBCT) Bone quality D2 to D3 on preoperative CBCT At least 3 mm of keratinized gingiva at the site Good compliance, evidenced by no missed appointments and a positive attitude toward oral hygiene

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Sahar Ghoraba, PhD

    Professor of Oral Medicine and Periodontology

    STUDY DIRECTOR

Central Study Contacts

Shady Talaat Zeyada, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Shady Talaat Zeyada

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 25, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 10, 2027

Last Updated

August 25, 2026

Record last verified: 2026-08