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NCT Number: NCT07303374

Flapless Immediate Implant Placement With Socket Shield Technique Versus Connective Tissue Graft in Anterior Maxilla

The present study aims to compare the dimensional stability of the supra-implant complex following flapless immediate implant placement using two socket management approaches: the connective tissue graft and the socket shield technique. Three-dimensional volumetric analysis and cone-beam computed tomography (CBCT) will be employed to assess and quantify changes in soft and hard tissue thickness and height surrounding the implant site.

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Key information

Conditions

Immediate Dental Implant Placement Connective Tissue Graft Socket Shield Technique

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The current study will include 28 non-restorable single maxillary anterior teeth indicated for extraction. Patients will be randomly allocated into two equal groups. The test group will undergo immediate implant placement combined with the socket shield technique and a customized healing abutment, whereas the control group will receive immediate implant placement with connective tissue grafting and a customized healing abutment. A pilot surgical guide will be used for both groups. The primary outcome measure will be labio-palatal ridge dimension changes changes. Secondary outcome measures included labial soft-tissue volumetric changes, bone formation labial to the implant, vertical bone level changes and pink esthetic score. All outcomes will be evaluated after a 12-month follow-up period.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Initial intact thick gingival biotype
  • 2 mm band of keratinized tissue,
  • Thin intact labial bone plate (< 1mm)
  • Good apical bone for primary stability
  • Patients who had provided an informed consent.

Exclusion criteria

  • Immediate implants with bone grafts or guided bone regeneration procedures
  • Uncontrolled diabetes mellitus
  • Patients taking IV bisphosphonates for treatment of osteoporosis
  • Patients with active infection related at the site of implant
  • Patients with untreated active periodontal diseases.

Treatment and study plan

IIP+Socket Shield

Procedure

The socket shield technique, which preserves a labial root fragment to maintain periodontal ligament support.

IIP+CTG

Procedure

connective tissue grafting which increases soft-tissue volume

Primary outcomes

  1. Soft tissue Volume gain/loss

    Time frame: one year

    The volumetric analysis in this clinical trial will be performed to obtain profilometric measurements. intraoral scans will be taken at baseline, 6- and 12-month post-operative for each patient. The best-fit algorithm will be used to superimpose digital surface models, when comparing each area of interest (AOI) throughout out the follow up period. Unchanged neighboring teeth surfaces will be used as a reference for proper superimposition. In each patient, the AOI will be kept constant for all pairwise comparisons. The volumetric analysis software will calculate the overall buccal soft tissue volume loss/gain (mm3) within the AOI for each patient.

Secondary outcomes

  1. Mid-facial gingival margin level

    Time frame: 12 months

    linear change of the Mid-facial gingival margin pre- and after one year

Study contacts

Contact information is provided by the study sponsor or research team.

Nourhan Gamal AbdelAziz, Masters

CONTACT

[email protected]

+201064249441

Sponsors and collaborators

Lead sponsor

International Dental Contiuing Education

Network

Registry information

Official study title

Supra-Implant Complex Stability Following Flapless Immediate Implant Placement With Socket Shield Technique Versus Connective Tissue Graft in Anterior Maxilla 1-Year Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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