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Immediate Dental ImplantNCT07020767

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

A study testing Vestibular Socket Therapy (VST) Group and Flap Elevation Group in people with Immediate Dental Implant and Tooth Extraction, run by Ain Shams University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 to 50 years
What is being tested?
Vestibular Socket Therapy (VST) Group and Flap Elevation Group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteEgypt
Study dates
1 Jan 2025to 1 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Nermeen Nagi

    Al Fayyum, Faiyum Governorate, 12883

Other trials in Egypt

About this study

Official title: Effect of Two Different Incision Techniques on Soft and Hard Tissue Outcomes in Immediate Implant Placement in Class II Extraction Sockets of the Esthetic Zone: A Randomized Controlled Clinical Trial

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.

Read the detailed description

Tooth extraction in the anterior maxilla, particularly in the esthetic zone, often leads to substantial resorption of the alveolar ridge, predominantly affecting the thin buccal bone plate. Studies have shown that up to 50% of horizontal ridge width can be lost within 6 months of extraction, compromising both soft tissue contours and the feasibility of future implant placement (Araújo \& Lindhe, 2005; Schropp, Wenzel, Kostopoulos, \& Karring, 2003). This resorption has profound esthetic and functional implications, especially in patients with high smile lines or thin periodontal biotypes.

To address these challenges, immediate implant placement was introduced to reduce treatment time, preserve socket dimensions, and optimize soft tissue outcomes (Kan, Rungcharassaeng, Umezu, \& Kois, 2003; Lang, Pun, Lau, Li, \& Wong, 2012). While immediate implants help maintain the overall ridge profile, they do not fully prevent bone remodeling of the buccal plate, which often results in soft tissue recession and compromised esthetic outcomes (Botticelli, Berglundh, Buser, \& Lindhe, 2003; Chen \& Buser, 2014).

Flap design during implant surgery has been identified as a critical factor influencing peri-implant bone and soft tissue healing. The traditional flap elevation approach provides good visibility but disrupts the periosteal blood supply, increasing the risk of bone resorption and soft tissue shrinkage (Fickl et al., 2008; Jeong et al., 2007). By contrast, flapless surgery preserves the periosteal blood supply and minimizes soft tissue trauma, leading to superior bone preservation and reduced postoperative discomfort (Becker, Goldstein, Becker, \& Sennerby, 2005; Oh, Shotwell, Billy, \& Wang, 2006). However, flapless techniques carry limitations such as reduced access and increased risk of malpositioning the implant or causing thermal bone damage without adequate irrigation (Choudhary et al., 2023).

To overcome the limitations of both approaches, Vestibular Socket Therapy (VST) was developed as a minimally invasive technique that allows simultaneous atraumatic extraction, implant placement, and socket augmentation through a small vestibular access incision (A. Elaskary et al., 2023). VST preserves the integrity of the labial soft tissues and periosteal blood supply, improves labial bone support, and enables simultaneous use of bone grafts and membranes to enhance both hard and soft tissue outcomes (Ghallab et al., 2023). Clinical trials comparing VST to conventional incisal extraction or partial extraction therapy (PET) have demonstrated comparable or superior outcomes in terms of Pink Esthetic Score (PES), soft tissue volume preservation, and facial bone thickness (A. Elaskary et al., 2023; Hamed et al., 2023).

Bone grafting materials used in combination with immediate implants have also been extensively studied. While autogenous bone has been considered the gold standard, it is often limited by donor site morbidity. Alternatives such as deproteinized bovine bone mineral (DBBM), demineralized bone matrix (DBM), and collagen plugs have been successfully used to fill peri-implant defects and support labial bone regeneration (Araújo \& Lindhe, 2005; Artzi, Tal, \& Dayan, 2000; Jensen \& Terheyden, 2009). Randomized controlled trials have shown that using a combination of autogenous bone chips with DBBM (e.g., MinerOss X) significantly increases facial bone thickness compared to collagen plug or DBM alone (Hamed et al., 2023).

Moreover, the Pink Esthetic Score (PES) has become a standard metric to assess esthetic outcomes around implants, evaluating parameters such as mesial and distal papilla fill, soft tissue level and contour, alveolar process deficiency, and tissue color and texture (Fürhauser et al., 2005). Studies have consistently shown that minimally invasive approaches, like VST and PET, score highly on PES, reflecting superior esthetic outcomes (Cosyn et al., 2011; Evans \& Chen, 2008).

Vestibular socket therapy (VST) has emerged as a promising minimally invasive approach for preserving soft and hard tissue architecture during immediate implant placement, particularly in challenging esthetic zones. However, its clinical performance compared to conventional flap elevation remains underexplored. This study aims to evaluate the effectiveness of VST combined with Allograft and collagen membrane in enhancing esthetic outcomes, soft tissue stability, and bone preservation advancing minimally invasive protocols toward more predictable, patient-centered care.

Being tested
Vestibular Socket Therapy (VST) Group, Flap Elevation Group
Keywords
Vestibular socket therapy, Class II extraction sockets, Immediate implant placement, Esthetic zone implants, Dental implant esthetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vestibular Socket Therapy (VST) GroupProcedure or surgery

    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.

  • Flap Elevation GroupProcedure or surgery

    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.

Study groups in NCT07020767
Study groupRoleWhat they receive
Vestibular Socket Therapy (VST) GroupExperimentalParticipants 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.
Receives: Procedure: Vestibular Socket Therapy (VST) Group
Flap Elevation GroupActive comparatorParticipants 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.
Receives: Procedure: Flap Elevation Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 and 12 months after prosthetic crown delivery

Secondary outcomes (3)
  1. Peri-Implant Probing Depth (PD)

    Probing depth measured at mesial and distal aspects of the implant using a UNC-15 periodontal probe. Change in depth over time will indicate peri-implant tissue stability.

    Measured: 6 and 12 months after prosthetic crown delivery

  2. Peri-Implant Mucosal Level Changes

    Vertical soft tissue height changes assessed at mesial papilla, mid-facial, and distal papilla using 3D superimposed intraoral scans. Positive values indicate soft tissue gain; negative values indicate recession.

    Measured: 6 and 12 months after prosthetic crown delivery

  3. Crestal Bone Level Changes

    Crestal bone thickness on the labial side of the implant measured using CBCT scans. Measurements taken at baseline, 6 months, and 12 months. Changes are calculated to assess bone preservation or loss.

    Measured: 6 and 12 months after prosthetic crown delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2025
  2. Study start1 Jan 2025
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07020767
Sponsor's protocol ID
R702
Status last verified
Jun 2025
First submitted
6 Jun 2025
Last updated
13 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Vestibular Socket Therapy (VST) Group and Flap Elevation Group in people with Immediate Dental Implant and Tooth Extraction, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pink Esthetic Score (PES) (time frame: 6 and 12 months after prosthetic crown delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.

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