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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07303374
Enrollment
28
Registered
2025-12-24
Start date
2026-02-28
Completion date
2027-05-31
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Connective Tissue Graft, Immediate Dental Implant Placement, Socket Shield Technique

Keywords

Socket Shield, Connective tissue graft

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREIIP+Socket Shield

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

PROCEDUREIIP+CTG

connective tissue grafting which increases soft-tissue volume

Sponsors

International Dental Contiuing Education
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Soft tissue Volume gain/lossone yearThe 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

MeasureTime frameDescription
Mid-facial gingival margin level12 monthslinear change of the Mid-facial gingival margin pre- and after one year

Countries

Egypt

Contacts

Primary ContactNourhan Gamal AbdelAziz, Masters
Nourhannegamal259@gmail.com+201064249441

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026