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

NCT07303374 | Not Yet Recruiting DMC

• 1 other identifier: IDCE-38122025
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Socket Shield; Connective tissue graft

Outcome Measures

Primary Outcomes (1)

• Soft tissue Volume gain/loss

  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.

  one year

Secondary Outcomes (1)

• Mid-facial gingival margin level

  12 months

Study Arms (2)

IIP+ Socket sheild

EXPERIMENTAL

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

Procedure: IIP+Socket Shield

IIP+CTG

ACTIVE COMPARATOR

connective tissue grafting which increases soft-tissue volume

Procedure: IIP+CTG

Interventions

IIP+Socket Shield PROCEDURE

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

IIP+ Socket sheild

IIP+CTG PROCEDURE

connective tissue grafting which increases soft-tissue volume

IIP+CTG

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Dental Contiuing Education: lead

Study Sites (1)

International Dental contiuing education

Cairo, Egypt

Location

Study Officials

• Nael Adel Mina, Masters

  International Dental Contiuing Education

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nourhan Gamal AbdelAziz, Masters

CONTACT

+201064249441; Nourhannegamal259@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 24, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)