MedDataX Logo

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

NCT ID: NCT07303374

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immediate Dental Implant Placement Connective Tissue Graft Socket Shield Technique

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Socket Shield Connective tissue graft

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IIP+ Socket sheild

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

Group Type EXPERIMENTAL

IIP+Socket Shield

Intervention Type PROCEDURE

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

IIP+CTG

connective tissue grafting which increases soft-tissue volume

Group Type ACTIVE_COMPARATOR

IIP+CTG

Intervention Type PROCEDURE

connective tissue grafting which increases soft-tissue volume

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IIP+Socket Shield

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

Intervention Type PROCEDURE

IIP+CTG

connective tissue grafting which increases soft-tissue volume

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

International Dental Contiuing Education

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nael Adel Mina, Masters

Role: PRINCIPAL_INVESTIGATOR

International Dental Contiuing Education

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

International Dental contiuing education

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nourhan Gamal AbdelAziz, Masters

Role: CONTACT

Phone: +201064249441

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nourhan Gamal Dr. Nourhan Gamal, Masters

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IDCE-38122025

Identifier Type: -

Identifier Source: org_study_id