Vestibular Socket Therapy in Immediate Implants With Grafting Materials

Sponsor
Mohamed Mofreh Hamada Hamed (Other)
Overall Status
Recruiting
CT.gov ID
NCT04957654
Collaborator
(none)
24
1
3
15.5
1.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
statistician will be blind
Primary Purpose:
Treatment
Official Title:
A Comparative Study Evaluating Vestibular Socket Therapy in Immediate Implants Using Different Grafting Materials
Actual Study Start Date :
Mar 16, 2021
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. changes in facial plate thickness [at baseline, 6 and 12 months]

    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

  2. changes in facial plate height [at baseline, 6 and 12 months]

    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

Secondary Outcome Measures

  1. changes in peri-implant mucosal level [at baseline, 3rd and 6th months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry, Tanta University Tanta Egypt

Sponsors and Collaborators

  • Mohamed Mofreh Hamada Hamed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Mofreh Hamada Hamed, clinical researcher, Tanta University
ClinicalTrials.gov Identifier:
NCT04957654
Other Study ID Numbers:
  • 04-21-13
First Posted:
Jul 12, 2021
Last Update Posted:
Jul 12, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 12, 2021