NCT06659081

Brief Summary

The goal of this clinical trial is to Evaluate of the soft tissue profile changes and labial plate of bone in the anterior esthetic area when using socket shield technique in conjunction with immediate implant and subepithelial connective tissue graft, in comparison to using immediate implant combined by subepithelial connective tissue graft. The main questions it aims to answer is :

  • does the socket shield technique better preserve gingival contours and connective tissues, resulting in improved esthetic outcomes?
  • Researchers will compare socket shield combined with immediate implant placement and a subepithelial connective tissue graft to immediate implant placement with just a subepithelial connective tissue graft to see if more favorable soft tissue profile changes and better preservation of the labial plate of bone are obtained. participants will : . subjected to partially extracted socket with immediately placed implant and subepithelial connective tissue graft. .subjected to immediate implant with subepithelial connective tissue graft.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

1.5 years

First QC Date

September 17, 2024

Last Update Submit

October 24, 2024

Conditions

Keywords

partial extraction therapy

Outcome Measures

Primary Outcomes (1)

  • Assessment of soft tissue profile around the implant

    \- Scanning of preoperative and postoperative cast , then Volumetric analysis of soft tissue by Superimposing the scans to evaluate the changes in the soft tissues in millimeters.

    change from baseline at six months

Secondary Outcomes (1)

  • Assessment of labial plate of bone around the implant

    change from baseline at six months

Study Arms (2)

socket shield technique

EXPERIMENTAL
Procedure: socket shield techniqueProcedure: subepithelial connective tissue graftProcedure: implant placement

immediate implant placement

EXPERIMENTAL
Procedure: subepithelial connective tissue graftProcedure: implant placement

Interventions

partial extraction therapy : sectioning the root and keeping part of it in contact with labial plate of bone

Also known as: partial extraction therapy
socket shield technique

A connective tissue graft harvesting from maxillary tuberosity area

immediate implant placementsocket shield technique

implant placement

immediate implant placementsocket shield technique

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Medically free
  • Maxillary esthetic zone extended to the second premolar with healthy roots
  • Good oral hygiene
  • Hopeless teeth

You may not qualify if:

  • Patients with systemic conditions that can affect bone turnover
  • Smokers
  • Pregnant women
  • Chronic and active periodontal disease
  • Vertical and horizontal root fracture
  • Dehiscence or fenestration of the labial plate of bone
  • Gingival recession

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry -Ain shams university

Cairo, Cairo Governorate, 3753450, Egypt

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationDentistryProsthodontics

Study Officials

  • Hala A. Abo el ela, professor

    faculty of dentistry- Ain shams university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 17, 2024

First Posted

October 26, 2024

Study Start

December 4, 2023

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

only IPD used in the results publication

Locations