Effect of Two Incision Techniques on Soft and Hard Tissue Outcomes in Immediate Implant Placement in Class II Extraction Sockets of the Esthetic Zone:

NCT07020767 | Active Not Recruiting

• 1 other identifier: R702
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial investigates the effect of two different surgical approaches-Vestibular Socket Therapy (VST) and Flap Elevation Technique-on soft and hard tissue outcomes during immediate implant placement in Class II extraction sockets of the anterior maxilla (esthetic zone). The study enrolled 26 systemically healthy adult patients contributing a total of 48 surgical sites. Each site was randomly assigned to one of the two treatment groups. The VST group employed a minimally invasive vestibular incision to allow atraumatic extraction, implant placement, bone grafting, and membrane placement while preserving the labial soft tissue and periosteal blood supply. The Flap Elevation group followed a conventional intrasulcular flap approach. In both groups, implants were placed with 30 Ncm torque and augmented with MegaOss™ allograft and a resorbable collagen membrane (T-barrier™). Clinical and radiographic evaluations were conducted at baseline, 6 months, and 12 months post-loading. Outcomes measured included Pink Esthetic Score (PES), peri-implant probing depth (PD), mucosal level changes, and crestal bone level changes.

Conditions

Immediate Dental Implant; Tooth Extraction; Class II Extraction Sockets; Esthetic Zone Implantology

Keywords

Vestibular socket therapy; Class II extraction sockets; Immediate implant placement; Esthetic zone implants; Dental implant esthetics

Outcome Measures

Primary Outcomes (1)

• Pink Esthetic Score (PES)

  The Pink Esthetic Score (PES) evaluates seven soft tissue parameters around implants: mesial papilla, distal papilla, soft tissue level, contour, alveolar process deficiency, tissue color, and texture. Each parameter is scored from 0 (poor) to 2 (ideal), with a total possible score of 14. Higher scores reflect better esthetic outcomes.

  6 and 12 months after prosthetic crown delivery

Secondary Outcomes (3)

• Peri-Implant Probing Depth (PD)

  6 and 12 months after prosthetic crown delivery

• Peri-Implant Mucosal Level Changes

  6 and 12 months after prosthetic crown delivery

• Crestal Bone Level Changes

  6 and 12 months after prosthetic crown delivery

Study Arms (2)

Vestibular Socket Therapy (VST) Group

EXPERIMENTAL

Participants in this group underwent immediate implant placement using Vestibular Socket Therapy (VST). A minimally invasive vestibular incision was made, followed by atraumatic extraction, implant placement (BioHorizons, 30 Ncm), bone grafting with MegaOss™ allograft, and placement of a T-barrier™ collagen membrane. The membrane was stabilized with tacks, and the site was closed with 7/0 nylon sutures. Healing was supported by customized composite healing abutments, and final zirconia crowns were delivered at 3 months.

Procedure: Vestibular Socket Therapy (VST) Group

Flap Elevation Group

ACTIVE COMPARATOR

Participants in this group received immediate implant placement using a conventional mucoperiosteal flap elevation approach. After intrasulcular and vertical incisions, atraumatic extraction was followed by implant placement (BioHorizons, 30 Ncm), grafting with MegaOss™ allograft, and coverage with a T-barrier™ collagen membrane, stabilized with tacks. The site was closed with 7/0 nylon sutures, and healing was supported with customized composite healing abutments. Final zirconia crowns were placed at 3 months.

Procedure: Flap Elevation Group

Interventions

Vestibular Socket Therapy (VST) Group PROCEDURE

A minimally invasive vestibular incision technique for atraumatic tooth extraction, followed by immediate implant placement using BioHorizons implants. The socket is augmented with MegaOss™ allograft and covered with T-barrier™ collagen membrane, stabilized with membrane tacks. Soft tissue closure is achieved with 7/0 nylon sutures. Customized composite healing abutments are used, and zirconia crowns are delivered at 3 months.

Vestibular Socket Therapy (VST) Group

Flap Elevation Group PROCEDURE

Traditional mucoperiosteal flap elevation with intrasulcular and vertical incisions, followed by atraumatic extraction and immediate implant placement using BioHorizons implants. The socket is grafted with MegaOss™ allograft, covered with T-barrier™ collagen membrane, and stabilized with tacks. The site is closed with 7/0 nylon sutures. Healing abutments and zirconia crowns are applied following the same timeline as the VST group.

Flap Elevation Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 20 to 50 years.
• Presence of one or more non-restorable or remaining roots in the maxillary anterior region (canine to canine).
• Class II extraction sockets confirmed by CBCT.
• Sufficient apical and palatal bone to ensure proper implant positioning and primary stability.
• Good compliance with treatment visits and oral hygiene.
• Medically healthy with no systemic diseases affecting wound healing or implant success.

You may not qualify if:

• Systemic conditions that contraindicate implant or periodontal surgery (e.g., immunocompromised, uncontrolled systemic disease).
• Smokers, diabetics, or pregnant/lactating women.
• History of chemotherapy or radiotherapy in the head and/or neck region.
• Patients on bisphosphonate therapy.
• Presence of acute infection at the intended implant site.

Sponsors & Collaborators

• Ain Shams University: lead
• Fayoum University: collaborator

Study Sites (1)

Nermeen Nagi

Al Fayyum, Faiyum Governorate, 12883, Egypt

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Fatma E.Sayed Hassanein

  Assistant Professor Of Oral Medicine, Periodontology, Oral Diagnosis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study employed single masking, where the clinical outcome assessors, radiographic evaluators, and statisticians were blinded to group assignments. The operating surgeon was not blinded due to the nature of the surgical procedures. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: Model Description (Additional Details): Participants were randomly assigned in a 1:1 ratio to one of two parallel groups: Vestibular Socket Therapy (VST) Group: Minimally invasive implant placement via vestibular access with bone grafting and collagen membrane. Flap Elevation Group: Conventional mucoperiosteal flap technique with the same implant and grafting protocol. Each surgical site (maximum of two per patient) was independently randomized. Outcome assessors and statisticians were blinded to group allocation to reduce bias. The trial aimed to evaluate differences in esthetic and tissue stability outcomes over a 12-month period.

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 13, 2025
• Study Start: January 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

EG (1)