Soft Tissue Stability in the Esthetic Zone: A Randomized Clinical Trial Comparing Vestibular Socket Therapy With Contour Augmentation for Compromised Adjacent Sockets

NCT06673446 | Withdrawn DMC

• 1 other identifier: 24-049
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 .

Conditions

Dental Implant in Compromised Adjacent Sockets

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. Tool to be used: 3shape trios 4 what will be assessed: * gingival recession * loss of interdental papillae height Data will be measured in millimeters

  6 months

Secondary Outcomes (1)

• Bone Regeneration

  6 months

Other Outcomes (1)

• Pink Esthetic Score (PES)

  6 months

Study Arms (2)

control group (contour augmentation

ACTIVE COMPARATOR

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.

Procedure: vestibular socket therapy

study group (VST)

ACTIVE COMPARATOR

1. Access and Socket Preparation: * 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. * Using special instruments from the VST kit. 2. Immediate Implant Placement with Guide: \* A prefabricated surgical guide ensures precise positioning of the implants directly into the socket. 3. Bone Grafting and Membrane: \* 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). 4. Closure and Healing: * The small incision is stitched closed with sutures. * A temporary healing cap is placed on the implants to facilitate proper healing.

Procedure: vestibular socket therapy

Interventions

vestibular socket therapy PROCEDURE

atraumatic extraction to the hopeless teeth will be performed using periotomes followed by conventional forceps under local anesthesia. 1. Access and Socket Preparation: * 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. * Using special instruments from the VST kit, the gum tissue is carefully dissected to expose the underlying bone. 2. Immediate Implant Placement with Guide: \* A prefabricated surgical guide ensures precise positioning of the implants directly into the socket. 3. Bone Grafting and Membrane: * 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. This membra

control group (contour augmentation; study group (VST)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults (20 to 50)
• 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).

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

The British university in Egypt

Cairo, Egypt

Location

Study Officials

• Mohamed Gamaleldin ahmed youssef, BDS

  The British University in Egypt

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 5, 2024
• Study Start: June 25, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

EG (1)