NCT05409950

Brief Summary

The study was conducted on 20 immediate implant placement sites in the anterior maxillary region. In the study group, 10 implants were inserted using socket shield technique, while in control group, 10 implants were inserted using conventional immediate placement technique. All patients received immediate and 6 months post-operative CBCT to assess horizontal bone loss, vertical bone loss, and measurement of bone density. Implant stability quotients (ISQs) was measured immediately, 1st, 3rd and 6 months post-operatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

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

September 16, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

1.3 years

First QC Date

May 24, 2022

Last Update Submit

June 4, 2022

Conditions

Keywords

Immediate implants, sockets shield technique, esthetic zone

Outcome Measures

Primary Outcomes (14)

  • Implant stability

    Using osstell

    immediate postoperative

  • Implant stability

    Using osstell

    one month post-operative

  • Implant stability

    Using osstell

    three month post-operative

  • Implant stability

    Using osstell

    six month post-operative

  • Horizontal gap

    Using cone-beam computed tomography

    immediate postoperative

  • Horizontal gap

    Using cone-beam computed tomography

    six month post-operative

  • Vertical bone loss

    Using cone-beam computed tomography

    immediate postoperative

  • Vertical bone loss

    Using cone-beam computed tomography

    six month post-operative

  • Bone density

    Using cone-beam computed tomography

    immediate postoperative

  • Bone density

    Using cone-beam computed tomography

    six month post-operative

  • peri-implant probing depth

    using periodontal probe

    immediate postoperative

  • peri-implant probing depth

    using periodontal probe

    one month post-operative

  • peri-implant probing depth

    using periodontal probe

    three month post-operative

  • peri-implant probing depth

    using periodontal probe

    six month post-operative

Study Arms (2)

Study group: implants were inserted using socket shield technique at the esthetic zone

ACTIVE COMPARATOR
Procedure: Immediate implant placement using socket shield technique

Control group: implants were inserted using conventional immediate technique

NO INTERVENTION

Interventions

Evaluation of socket shield technique with immediate implant placement at the esthetic zone in comparison with the conventional immediate implant placement

Study group: implants were inserted using socket shield technique at the esthetic zone

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Endodontic or non-endodontic treated un-restorable remaining root/ tooth related to maxillary anterior teeth.
  • Healthy adult patients \> 20 years old (ASAI, II) .
  • Adequate oral hygiene.
  • Intact periodontal tissues.

You may not qualify if:

  • Periapical or periodontal active infection involving the teeth/root to be extracted (as excluded by radiographic examination).
  • Medically compromised patients (ASA III, IV, V).
  • Patients receiving chemotherapy or radiotherapy.
  • Heavy smokers,alcohol or drug abuse.
  • Patients with parafunctional habits such as bruxism, clenching, excessive gum chewing, lip or fingernail biting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez canal university

Ismailia, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2022

First Posted

June 8, 2022

Study Start

September 16, 2019

Primary Completion

January 6, 2021

Study Completion

September 7, 2021

Last Updated

June 8, 2022

Record last verified: 2022-06

Locations