Clinical trial NCT06673446: Soft Tissue Stability in the Esthetic Zone: A Randomized Clinical Trial Comparing Vestibular Socket Therapy With Contour Augmentation for Compromised Adjacent Sockets
Official title: Soft Tissue Stability in the Esthetic Zone: A Randomized Clinical Trial Comparing Vestibular Socket Therapy With Contour Augmentation for Compromised Adjacent Sockets
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implant in Compromised Adjacent Sockets
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Soft Tissue Stability
timeFrame: 8 months
Secondary outcomes:
measure: Bone Regeneration
timeFrame: 8 months
Other outcomes:
measure: Pink Esthetic Score (PES)
timeFrame: 8 months
Locations:
city: Cairo
country: Egypt
facility: The British university in Egypt
Study officials:
affiliation: The British University in Egypt
name: Mohamed Gamaleldin ahmed youssef, BDS
role: PRINCIPAL_INVESTIGATOR
References: