Soft Tissue Stability in Immediate Implant Placement Using (VST) Versus Conventional Flap in Type II Extraction Sockets

Not Applicable

Active, not recruiting

• Conditions: Badly Broken Tooth in a Socket Type II Eligible to be Replaced by Immediate Implant
• Interventions: Procedure: Vestibular socket therapy; Procedure: conventional full thickness flap

• Registration Number: NCT06324747
• Lead Sponsor: British University In Egypt

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.

Study Timeline

• Study Start: 2023-10-23
• Study First Submitted: 2023-12-04
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-20
• Last Update Submitted: 2024-03-20
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-10-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Vestibular socket therapy	Elaskary Vestibular socket therapy instruments will be used for the intervention, A 1 cm long vestibular access incision at the allocated hopeless tooth will be made at the base of the hopeless tooth to the adjacent teeth. The vestibular pouch will then be dissected in an incisal direction exposing the total socket area and allowing direct access to the socket environment. An immediate implant will be installed using a surgical guide. A membrane shield 1 mm thick will be, trimmed, and tucked through the vestibular access incision starting at 1 mm beyond the socket orifice and reaching to the apical area of the socket. The gap and/ or the defect between the implant body and the shield will then be filled with the same grafting components so the control group. Finally, the vestibular incision will be secured with sutures. The socket will be sealed with a customized healing abutment.
Control group	conventional full thickness flap	Control group will have a full thickness flap, followed by an immediate implant placement using a surgical guide. Then a guided bone regeneration will be achieved by bone graft (autogenous bone chips and xenograft particles and a membrane barrier 1 mm thickness will be applied. The membrane shield then will be stabilized to the apical bone using 2 membrane tacks, customized healing abutment will be connected , then, the elevated flap will be sutured to its original position.

Primary Outcome Measures

Name	Time	Method
Soft Tissue Stability	8 months	it will be measured digitally using the intraoral scanner. A preoperative scanning, immediate postoperative, 2 months postoperative and 8 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

Secondary Outcome Measures

Name	Time	Method
Bone Regeneration	8 months	measuring the thickness of the labial plate of bone.; It will be measured preoperatively, immediate postoperative to measure the amount of the augmented bone, 2 months postoperatively and 8 months post operative.; Tool to be used: cone beam computed tomography (cbct)

Trial Locations

Locations (1)

The British university in Egypt; 🇪🇬 Cairo, New Cairo, Egypt