NCT05878392

Brief Summary

36 patients, were included in this study. They were chosen from the Outpatient Clinic in the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of non-restorable maxillary anterior and premolar teeth (esthetic zone) by immediate implant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

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

January 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

May 9, 2023

Last Update Submit

May 18, 2023

Conditions

Immediate Implant

Outcome Measures

Primary Outcomes (1)

  • marginal bone loss

    Cone Beam CT (CBCT) was used measure marginal bone loss

    1 year

Secondary Outcomes (2)

  • Implant Stability:

    1 year

  • Peri-implant Pocket depth

    1 year

Study Arms (3)

group 1

EXPERIMENTAL

immediate implant placement and the buccal jumping gap was packed using PRF

Other: bone filling materials

group 2

EXPERIMENTAL

immediate implant placement and the buccal jumping gap was packed using xenograft

Other: bone filling materials

group 3

EXPERIMENTAL

immediate implant placement and the buccal jumping gap was packed using alloplast

Other: bone filling materials

Interventions

bone filling materialsOTHER

the buccal jumping gap was packed using PRF in group 1 the buccal jumping gap was packed using xenograft in group 2 the buccal jumping gap was packed using Alloplastic β-tricalcium phosphate in group 3

group 1group 2group 3

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient medically free from systemic diseases.
  • Age above 18 years.
  • A single maxillary anterior or premolar tooth that cannot be restored.
  • No acute infection is present.
  • Patients with sufficient quality and quantity of bone.
  • Free from history of bruxism.

You may not qualify if:

  • A medical condition that would prevent implant surgery.
  • Existence of non-treated generalized progressive periodontitis.
  • Patients who are smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heba Elsheikh

Mansoura, Egypt, 002, Egypt

Location

Related Publications (1)

  • Elsheikh HA, Abdelsameaa SE, Elbahnasi AA, Abdel-Rahman FH. Comparison between platelet rich fibrin as space filling material versus xenograft and alloplastic bone grafting materials in immediate implant placement: a randomized clinical trial. BMC Oral Health. 2023 Dec 8;23(1):977. doi: 10.1186/s12903-023-03678-5.

    PMID: 38066454DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

May 26, 2023

Study Start

January 1, 2022

Primary Completion

June 1, 2022

Study Completion

January 1, 2023

Last Updated

May 26, 2023

Record last verified: 2023-05

Locations

EG(1)