Vestibular Socket Therapy in Immediate Implants With Grafting Materials

NCT04957654 | Unknown

• 1 other identifier: 04-21-13
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Tooth Extraction; Dental Implant; Extarction Socket

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• changes in peri-implant mucosal level

  at baseline, 3rd and 6th months

Study Arms (3)

VST with collagen plug soaked in blood

EXPERIMENTAL

Other: VST with collagen plug soaked in blood

VST with Allograft Demineralized bone matrix Grafton

ACTIVE COMPARATOR

Other: VST with Allograft Demineralized bone matrix Grafton

VST with autogenous cortical chips and bovine deprotinzed particles

ACTIVE COMPARATOR

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

Interventions

VST with collagen plug soaked in blood OTHER

-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 collagen plug soaked in blood

VST with Allograft Demineralized bone matrix Grafton OTHER

-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 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 OTHER

-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

VST with autogenous cortical chips and bovine deprotinzed particles

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mohamed Mofreh Hamada Hamed: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, Egypt

RECRUITING

Related Publications (1)

• Hamed MM, El-Tonsy MM, Elaskary A, Abdelaziz GO, Saeed SS, Elfahl BN. Effect of three different grafting materials on immediate implant placement using vestibular socket therapy in class II extraction sockets in the maxillary esthetic zone: a randomized controlled clinical trial. BMC Oral Health. 2023 Sep 1;23(1):623. doi: 10.1186/s12903-023-03345-9.

  PMID: 37658342 DERIVED

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Mohamed M Hamed, BDS

CONTACT

01023888701; mohamedhamed628@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: statistician will be blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinical researcher

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 12, 2021
• Study Start: March 16, 2021
• Primary Completion: April 30, 2022
• Study Completion: July 1, 2022
• Last Updated: July 12, 2021

Record last verified: 2021-07

Locations

EG (1)