Soft Tissue Graft Versus Acellular Dermal Matrix in Preservation of Buccal Plate of Bone

Soft Tissue Graft Versus Acellular Dermal Matrix in Preservation of Buccal Plate of Bone After Immediate Implant Placement

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

Study Overview

• Status: Completed
• Conditions: Comparative Study
• Intervention / Treatment: Combination product: Acellular Dermal Matrix

Detailed Description

It was conclude that SCTG is the gold standard for soft tissue augmentation up till now, However ADM can be alternative to autogenous soft tissue graft.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Madīnat Nāşir, Egypt
    • Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Medically free

Exclusion Criteria:

Heavy smoking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADM and SCTG	Combination product: Acellular Dermal Matrix; Feasibility of soft tissue graft after immediate implant placement
Experimental: Acellular Dermal Matrix and soft tissue graft; 12participatent in two groups	Combination product: Acellular Dermal Matrix; Feasibility of soft tissue graft after immediate implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Buccal bone thickness	Assess the buccal bone thickness before and after the graft application	6 months follow up

Collaborators and Investigators

• Sponsor: Faculty of Dental Medicine for Girls
• Investigators: Principal Investigator: Azhar Journal, No affliction

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2020
• Primary Completion (Actual): November 20, 2022
• Study Completion (Actual): May 20, 2023

Study Registration Dates

• First Submitted: December 29, 2023
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Estimated): January 29, 2024

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Nmohamed

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Soft tissue graft versus acellular dermal matrix in preservation of buccal plate of bone after immediate implant placement
• IPD Sharing Time Frame: 6 months follow up
• IPD Sharing Access Criteria: https://www2.cloud.editorialmanager.com/azjd/default2.aspx
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No