Effect of Subepithelial Connective Tissue Graft with Socket Shield Technique
1 other identifier
interventional
14
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2023
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
September 17, 2024
CompletedFirst Posted
Study publicly available on registry
October 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedOctober 26, 2024
October 1, 2024
1.5 years
September 17, 2024
October 24, 2024
Conditions
Keywords
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
EXPERIMENTALimmediate implant placement
EXPERIMENTALInterventions
partial extraction therapy : sectioning the root and keeping part of it in contact with labial plate of bone
A connective tissue graft harvesting from maxillary tuberosity area
Eligibility Criteria
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hala A. Abo el ela, professor
faculty of dentistry- Ain shams university
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