NCT04882761

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

3.8 years

First QC Date

February 27, 2021

Last Update Submit

May 6, 2021

Conditions

Dental Implant

Outcome Measures

Primary Outcomes (1)

  • Soft tissue stability

    Pink esthetic score

    6 months postoperatively

Secondary Outcomes (1)

  • Bone stability

    6 months postoperatively

Study Arms (2)

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

Device: Dental implant

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

Device: Dental implant

Interventions

Dental implantDEVICE

Comparative

Socket shield in direct contact with dental implantSocket shield with gap and xenograft with dental implant

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doaa Khattab

Cairo, Abbassia, 11566, Egypt

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Doaa Adel-Khattab, PhD

    Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 27, 2021

First Posted

May 12, 2021

Study Start

April 12, 2017

Primary Completion

January 20, 2021

Study Completion

February 24, 2021

Last Updated

May 12, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)