Vestibular Socket Therapy in Immediate Implants With Grafting Materials

Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04957654
• Other study ID #: 04-21-13
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2021
• Source: Tanta University
• Contact: Mohamed M Hamed, BDS
• Phone: 01023888701
• Email: mohamedhamed628[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 1, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant
• Tooth Extraction

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Mofreh Hamada Hamed

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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