NCT07063836

Brief Summary

While early implant placement with guided bone regeneration (GBR) offers advantages, the desire for reduced treatment time and fewer surgical steps continues to drive the exploration of alternative approaches. In this context, the recent introduction of vestibular socket therapy (VST) presents an intriguing option. VST utilizes a minimally invasive tunnel access technique through the vestibular area to perform socket augmentation for immediate implant placement in compromised extraction sockets .

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

July 3, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 14, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 3, 2025

Last Update Submit

August 4, 2025

Conditions

Keywords

dental implant, compromised socket, bone augmentation

Outcome Measures

Primary Outcomes (1)

  • soft tissue stability

    it will be measured digitally using the intraoral scanner. A preoperative scanning, immediate postoperative, 3 months postoperative and 6 months postoperative scanning will be done.

    6 months after final restoration

Secondary Outcomes (1)

  • buccal plate of bone regeneration

    6 months

Other Outcomes (1)

  • Pink esthetic score

    6 months

Study Arms (2)

vestibular socket therapy

EXPERIMENTAL

A small incision (1 cm) is made on (vestibular area) near the base of the extracted teeth, extending slightly towards neighboring teeth. This creates a pouch for accessing the socket and surrounding bone.An immediate implant is inserted using a guide and covered with a cortical membrane

Procedure: VST

Contour augmentation and early implant placement

ACTIVE COMPARATOR

early implant placement after socket healing for four weeks using bioplug along with contour augmentation using bone and membrane

Procedure: contour augmentation and early implant placement

Interventions

VSTPROCEDURE

atraumatic extraction to the hopeless teeth will be performed using periotomes followed by conventional forceps under local anesthesia.A small incision (1 cm) is made on (vestibular area) near the base of the extracted teeth, extending slightly towards neighboring teeth.Using special instruments from the VST kit, the gum tissue is carefully dissected to expose the underlying bone and an immediate implant is placed using a surgical guide. the augmentation is done using A mixture of bone chips harvested from the surgical site (autogenous bone) and a bone-grafting material (deproteinized bovine bone mineral) is used to fill any gaps and support the implant, especially in the labial bone wall (labial plate). A special 0.6 mm thick membrane is inserted through the access incision. the vestibular incision is then sutured and the provisional is inserted.

vestibular socket therapy

Teeth extraction : minimally invasive adjacent teeth extraction under anesthesia using periotome and forceps. the empty sockets will be filled with a special collagen material (BioPlug) to aid healing for 4 to 8 weeks. flap elevation : a full-thickness flap will be carefully raised using a crestal incision extended one tooth mesial and distal to the extraction location, then connected with two vertical incisions extended through the sulcus forming a trapezoid flap. Implants Insertion: The two implant is then placed into the prepared sockets using surgical guide. Bone Grafting: Any bone deficiencies are addressed by grafting. This involves placing a layer of (autogenous bone) directly on the two implants' surface, followed by a layer of a bone-grafting material (Demineralized Bone Matrix). Membrane Placement: A double-layered collagen membrane is used to cover the grafted area. Flap Closure: The previously lifted flap is repositioned and sutured back in place.

Contour augmentation and early implant placement

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- patients with two adjacent hopeless maxillary teeth or remaining roots in the esthetic region missing coronal tooth structure, type II socket (deficient labial plate of bone and intact overlying soft tissues), adequate palatal bone, ≥ 3 mm apical bone to engage the immediately placed implants, thereby achieving optimum primary stability (a minimum of 30 Ncm insertion torque) following teeth extraction.
  • acceptable compliance and oral hygiene.

You may not qualify if:

  • medically compromised patients. (Systemic diseases). general contraindication for implant placement. (Untreated periodontitis, severe bruxism , immunosuppression , uncontrolled diabetes , smokers , patients under radiation therapy, patients on bisphosphonate medications).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The British university in Egypt

Cairo, Egypt

RECRUITING

Study Officials

  • Mohamed Yousef, B.D.S

    British University In Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed G yousef, B.D.S

CONTACT

Al Hassan Diab, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 14, 2025

Study Start

July 14, 2025

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

August 7, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations