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Clinical Trials in Egypt / NCT07020767
Active, not recruiting Not applicable

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 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-01-01
Last updated
2025-06-13

Condition(s) studied

Immediate Dental ImplantTooth ExtractionClass II Extraction SocketsEsthetic Zone Implantology

Investigational drug(s) / intervention(s)

Vestibular Socket Therapy (VST) GroupFlap Elevation Group

Vestibular Socket Therapy (VST) Group: 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 Group: 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 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Nermeen Nagi Al Fayyum Faiyum Governorate

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07020767 on ClinicalTrials.gov ↗ ← All trials in Egypt