NCT06229561

Brief Summary

Comparative study between 2 groups to assess the feasibility of using Acellular dermal matrix vs Soft tissue Graft after immediate implant placement

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2020

Typical duration for phase_1

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 18, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

2.8 years

First QC Date

December 29, 2023

Last Update Submit

January 19, 2024

Conditions

Comparative Study

Outcome Measures

Primary Outcomes (1)

  • Buccal bone thickness

    Assess the buccal bone thickness before and after the graft application

    6 months follow up

Study Arms (2)

ADM and SCTG

EXPERIMENTAL

ADM and SCTG

Combination Product: Acellular Dermal Matrix

Acellular Dermal Matrix and soft tissue graft

EXPERIMENTAL

12participatent in two groups

Combination Product: Acellular Dermal Matrix

Interventions

Acellular Dermal MatrixCOMBINATION_PRODUCT

Feasibility of soft tissue graft after immediate implant placement

ADM and SCTGAcellular Dermal Matrix and soft tissue graft

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Medically free

You may not qualify if:

  • Heavy smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azhar University

Nāşir, Egypt

Location

Related Publications (1)

  • Elaskary A, Abdelrahman H, Elfahl B, Elsabagh H, El-Kimary G, Ghallab NA. Immediate Implant Placement in Intact Fresh Extraction Sockets Using Vestibular Socket Therapy Versus Partial Extraction Therapy in the Esthetic Zone: A Randomized Clinical Trial. Int J Oral Maxillofac Implants. 2023 May, Jun;38(3):468-478. doi: 10.11607/jomi.9973.

    PMID: 37279214RESULT

Study Officials

  • Azhar Journal

    No affliction

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investor

Study Record Dates

First Submitted

December 29, 2023

First Posted

January 29, 2024

Study Start

January 18, 2020

Primary Completion

November 20, 2022

Study Completion

May 20, 2023

Last Updated

January 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Soft tissue graft versus acellular dermal matrix in preservation of buccal plate of bone after immediate implant placement

Shared Documents
STUDY PROTOCOL
Time Frame
6 months follow up
Access Criteria
https://www2.cloud.editorialmanager.com/azjd/default2.aspx
More information

Locations

EG(1)