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

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 .

Study Overview

• Status: Withdrawn
• Conditions: Dental Implant in Compromised Adjacent Sockets
• Intervention / Treatment: Procedure: vestibular socket therapy

Detailed Description

The concept of immediate implant placement has been around for a while. Professor Wilfried Schulte conducted the first study on this technique in 1978, Extensive studies conducted over the past 40 years have demonstrated that immediate implant placement is a safe and effective method for restoring teeth that are badly destructed.

While immediate implant placement has been shown as a viable option, new studies using advanced imaging techniques (cone beam CT scans) reveal limitations in the front upper jaw (anterior maxilla).

• Thin Bone Walls: These scans show that a thick bone wall, ideal for implant stability, is uncommon in this area. Only about 5% of patients have a thick wall (>1mm) in the central incisor region.
• Facial Bone Defects: Another recent study found that over half (52%) of implant sites in the central incisor area have a missing facial bone wall (defect).

These findings highlight the main concerns with immediate implants in the front upper jaw:

• Bone Instability: Thin bone and missing facial bone can lead to an unstable implant, especially in the thin tissue layer at the front of the jaw (labial plate).
• Soft Tissue instability: An unstable implant can cause the gum tissue to recede, compromising the cosmetic outcome in this highly visible area.

researchers like Buser et al. propose a treatment option that offers documented long-term predictability for achieving good aesthetic outcomes. This approach involves:

• Early Implant Placement (Type 2): The implant is placed shortly after tooth extraction.
• Flap Surgery: This surgical technique allows for better access to the bone for grafting.
• Guided Bone Regeneration: Bone grafting material is used to stimulate new bone growth in the missing facial bone area.
• Submerged Healing: The implant is left covered by gum tissue for a period of healing before attaching the final restoration.

This alternative approach addresses the challenges of immediate implant placement in cases with missing facial bone walls in the front upper jaw, while offering a predictable and aesthetically pleasing long-term solution.

A recent studies compared an alternative approach to the contour augmentation technique. The technique is the novel vestibular socket therapy proposed by ELaskary et al.

The findings suggest VST may be a viable option for these situations, offering comparable bone formation and improved soft tissue stability while streamlining the treatment process with fewer surgical interventions.

The study found that VST offered several advantages:

• More stable gum tissue
• Similar bone growth compared to contour augmentation
• Faster treatment time
• Fewer surgeries Overall, VST appears to be a promising alternative to contour augmentation for implant placement.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • The british university in egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group (contour augmentation; 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; atraumatic extraction to the hopeless teeth will be performed using periotomes followed by conventional forceps under local anesthesia.; 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.; Immediate Implant Placement with Guide:* A prefabricated surgical guide ensures precise positioning of the implants directly into the socket.; 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
Active Comparator: study group (VST); 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.; Immediate Implant Placement with Guide:* A prefabricated surgical guide ensures precise positioning of the implants directly into the socket.; 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).; 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; atraumatic extraction to the hopeless teeth will be performed using periotomes followed by conventional forceps under local anesthesia.; 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.; Immediate Implant Placement with Guide:* A prefabricated surgical guide ensures precise positioning of the implants directly into the socket.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Regeneration	measuring the thickness of the labial plate of bone. It will be measured preoperatively, immediate postoperative to measure the amount of the augmented bone, 3 months postoperatively and 6 months post operative. Tool to be used: cone beam computed tomography (cbct)	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pink Esthetic Score (PES)	The PES is based on seven variables: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color and soft tissue texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score.	6 months

Collaborators and Investigators

• Sponsor: British University In Egypt
• Investigators: Principal Investigator: Mohamed Gamaleldin ahmed youssef, BDS, The british university in egypt

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 2, 2024
• First Submitted That Met QC Criteria: November 2, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 24-049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No