Vestibular Socket Therapy in Immediate Implants With Grafting Materials

A Comparative Study Evaluating Vestibular Socket Therapy in Immediate Implants Using Different Grafting Materials

The current research aims at evaluating the outcomes of the vestibular socket therapy in immediate implants using collagen plug, demineralized freeze-dried bone allograft, and deproteinized bovine bone minerals at both radiographic and clinical levels

Study Overview

• Status: Recruiting
• Conditions: Dental Implant; Tooth Extraction; Extarction Socket
• Intervention / Treatment: Other: VST with collagen plug soaked in blood; Other: VST with Allograft Demineralized bone matrix Grafton; Other: VST with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed M Hamed, BDS; Phone Number: 002 01023888701; Email: mohamedhamed628@gmail.com

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • Faculty of Dentistry, Tanta University
    • Contact: Mohamed M Hamed, BDS; Phone Number: 002 01023888701; Email: mohamedhamed628@gmail.com
    • Principal Investigator: Mohamed M Hamed, BDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients will be included if they have one or more hopeless teeth without signs of acute infection in the maxillary anterior region.
• Remaining roots or non-restorable teeth with sufficient bone apically and palatably to allow proper implant positioning with sufficient primary stability.
• Optimal compliance as evidenced by no missed treatment appointments and a positive attitude towards oral hygiene.
• Medically free

Exclusion Criteria:

• Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
• Smokers, diabetics, pregnant or lactating women.
• History of chemotherapy, radiotherapy in head and/or neck region.
• Bisphosphonate therapy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VST with collagen plug soaked in blood	Other: VST with collagen plug soaked in blood; -A sub mucoperiosteal tunnel will be created, a membrane shield will be trimmed to fit the facial wall of the socket and introduced through the tunnel lying over the facial bone plate, and the facial gap will be filled with collagen plug soaked in blood
Active Comparator: VST with Allograft Demineralized bone matrix Grafton	Other: VST with Allograft Demineralized bone matrix Grafton; -A sub mucoperiosteal tunnel will be created, a membrane shield will be trimmed to fit the facial wall of the socket and introduced through the tunnel lying over the facial bone plate, and the facial gap will be filled with Allograft Demineralized bone matrix Grafton
Active Comparator: VST with autogenous cortical chips and bovine deprotinzed particles	Other: VST with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles; -A sub mucoperiosteal tunnel will be created, a membrane shield will be trimmed to fit the facial wall of the socket and introduced through the tunnel lying over the facial bone plate, and the facial gap will be filled with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in facial plate thickness	Each group will be subjected to: Cone beam computed tomography (CBCT) at baseline, 6 months, and 12months to assess the thickness of the labial (facial) plate of bone and implant survival	at baseline, 6 and 12 months
changes in facial plate height	Each group will be subjected to: Cone beam computed tomography (CBCT) at baseline, 6 months, and 12months to assess height of labial (facial) plate of bone and implant survival	at baseline, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in peri-implant mucosal level	Each group will be subjected to Intraoral scanning at baseline, 6 months and 12 months. The changes in peri-implant mucosal level will be assessed by superimposition of scanning files of different intervals to monitor the changes in surface area calculated by software.	at baseline, 3rd and 6th months

Collaborators and Investigators

• Sponsor: Mohamed Mofreh Hamada Hamed

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 5, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 04-21-13

Drug and device information, study documents

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