Clinical trial NCT06324747: Soft Tissue Stability in Immediate Implant Placement Using (VST) Versus Conventional Flap in Type II Extraction Sockets
Official title: Soft Tissue Stability in Immediate Implant Placement Using the Vestibular Socket Therapy Versus Conventional Flap in Type II Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Badly Broken Tooth in a Socket Type II Eligible to be Replaced by Immediate Implant
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two equal parallel groups with a 1:1 allocation ratio to receive either vestibular socket therapy (test group) or to be treated with conventional mucoperiosteal flap (control group).
Primary purpose: TREATMENT

Brief summary: This study compare between the vestibular socket therapy (VST) and the traditional mucoperiosteal flap reflection in immediate implant placement in type II extraction socket in the esthetic zone.

The technique of vestibular socket therapy (VST), introduced by Elaskry, enables the placement of implants immediately while simultaneously rehabilitating the entire socket, resulting in excellent esthetic and functional outcomes that meet the expectations of patients. VST involves socket augmentation through a minimally invasive vestibular access incision, eliminating the need for the traditional mucoperiosteal flap reflection, regardless of the extent of socket compromise.

Detailed description: Several methods have been suggested for the treatment of class 2 socket types with immediate implant placement. One such technique is the immediate dento-alveolar restoration (IDR), which involves the incorporation of a tuberosity bone graft into the buccal defect, restoring the missing buccal bone walls. However, this technique has some limitations, including the lack of graft stabilization to the host bed, the high rate of bone graft remodeling, and the limited availability of tuberosity bone when wisdom teeth are present.

In contrast, Buser D. extensively researched the early implant placement method. This approach involves extracting the tooth and then waiting for a delay period of 8-12 weeks. According to the authors, this timeframe allows for the development of ample keratinized tissues, the elimination of socket infection, and the occurrence of post-extraction bone remodeling.

In contrast, both early placement and contour augmentation procedures have demonstrated certain drawbacks. These include the collapse of socket walls in both horizontal and vertical directions after tooth extraction, the need for a lengthy treatment duration that can extend up to 8 months, the challenges of maintaining provisional restorations during this extended period, and the potential for post-restorative socket tissue recession due to the reflection of the mucoperiosteal flap . As a result, achieving a successful esthetic treatment outcome becomes difficult to predict.

The technique of vestibular socket therapy (VST), introduced by Elaskry et al. , enables the placement of implants immediately while simultaneously rehabilitating the entire socket, resulting in excellent esthetic and functional outcomes that meet the expectations of patients. VST involves socket augmentation through a minimally invasive vestibular access incision, eliminating the need for the traditional mucoperiosteal flap reflection, regardless of the extent of socket compromise .

The procedure involves making a horizontal incision in the vestibule at the base of the mucogingival junction of the extracted tooth. This is followed by implant placement without the need for a flap, grafting the compromised socket walls through the vestibular access incision. The labial bone defect, which has been grafted with a bone graft, is then protected using a cortical equine membrane, and finally, the socket opening is sealed with a customized healing collar.

Eligibility criteria: Inclusion Criteria:

* Hopeless maxillary tooth 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

Exclusion Criteria:

* Smokers
* Pregnant women
* Patients with systemic diseases
* History of chemotherapy or radiotherapy within the past 2 years.

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
state: New Cairo
Study officials:
affiliation: The British University in Egypt
name: Mohamed Shawky, BDS
role: PRINCIPAL_INVESTIGATOR
References: