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Clinical Trials/NCT04882761
NCT04882761CompletedPhase 4

Evaluation of Soft Tissue Stability and Labial Plate of Bone of Immediate Implant in Direct Contact Versus Gap With Socket Shield (A Randomized Clinical Study)

Ain Shams University1 site in 1 country16 target enrollmentStarted: April 12, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
16
Locations
1
Primary Endpoint
Soft tissue stability

Study Overview

Brief Summary

To evaluate socket shield technique either placing implant in direct contact to tooth fragment versus gap created between the tooth and implant.

Detailed Description

Patients with a non-restorable tooth located in anterior maxillary arch was included in this study, patients were divided into two groups, eight implants per group, both groups had socket shield, group 1 will have implant in direct contact with shield, second group had a gap between dental implant and shield. soft tissue stability, bone width and implant stability was assessed preoperatively, immediate and 6 months postoperative.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with a non-restorable tooth located in anterior maxillary arch (upper right second premolar to upper left second premolar). Tooth to be extracted is endodontically treated and free from periapical infection.
  • •Systemic free patients according to modified Cornell medical index (Brodmank and Erdmann 1949).
  • •Patients with good compliance.

Exclusion Criteria

  • •Teeth with current acute periapical infection or sinus tracts.
  • •Heavy smokers and patients with bruxism habits.
  • •Patients with poor oral hygiene or not willing to perform oral hygiene measures.
  • •Vulnerable groups (as pregnant females and decisionally impaired individuals).

Arms & Interventions

Socket shield in direct contact with dental implant

Active Comparator

eight partially extracted sockets where implant (Neobiotech) was placed in direct contact to socket shield

Intervention: Dental implant (Device)

Socket shield with gap and xenograft with dental implant

Active Comparator

eight partially extracted sockets where a gap was left between implant (Neobiotech) and socket shield

Intervention: Dental implant (Device)

Outcomes

Primary Outcomes

Soft tissue stability

Time Frame: 6 months postoperatively

Pink esthetic score

Secondary Outcomes

  • Bone stability(6 months postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Doaa Adel Salah Khattab

Dr

Ain Shams University

Study Sites (1)

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