Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06241196
Other study ID # Implant_22
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 1, 2022
Est. completion date April 1, 2024

Study information

Verified date January 2024
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate and compare the Vestibular Socket Therapy (VST) technique using alloderm versus connective tissue graft both with xenogenic bone membrane in immediate implants of anterior aesthetic zone.


Description:

Twenty surgical sites will be divided into two groups; each of which has 10 surgical sites. Grouping will be done randomly sequentially numbered, opaque, sealed envelopes (SNOSE) The groups will be treated as follow: - Group I: Ten sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft. - Group II: Ten sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft 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. The changes in gingival phenotype could be assessed at 6 months and 12 months intervals by superimposition of DICOM files on CBCT software Each group will be subjected to Cone Beam Computed Tomography (CBCT) at baseline, 6 months and 12months to asses both thickness and height of labial (facial) plate of bone and implant survival.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - Adults (20-50) years old. - Class II socket according to Elian et al, (7)described as facial soft tissue is present but the buccal plate is partially missing following extraction of the tooth in the maxillary anterior region. - Thin gingival phenotype. - Bone quality ranges from D2-D3 as gained from preoperative cone beam computed tomography. - Presence of at least 3 mm of keratinized gingiva. - Optimal compliance as evidenced by no missing treatment appointments and positive attitude towards oral hygiene. 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 Design


Related Conditions & MeSH terms


Intervention

Device:
implant
Implant will be placed through the surgical guide in the extraction socket
Procedure:
Vestibular Socket Therapy
tunnel incision will be made in labial vestibule
Drug:
Alloderm
allogenic soft tissue substitute
Xenogenic bone membrane shield
xenogenic bone membrane
Procedure:
Connective tissue graft
soft tissue harvesting from palate

Locations

Country Name City State
Egypt TantaU Tanta Gharbia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes in peri-implant mucosal level level of peri-implant mucosa baseline, 6, 12 months
Primary changes in gingival phenotype thickness of peri-implant mucosa baseline, 6, 12 months
Secondary thickness of labial (facial) plate of bone three area measures of facial bone baseline, 6, 12 months
Secondary implant survival implant stability, health, mobility and function baseline, 6, 12 months
Secondary height of labial (facial) plate of bone Apico-coronal height of labial bone baseline, 6, 12 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06040788 - Effect of Tooth Angulation, Alveolar and Basal Bone Anatomical Characteristics on Soft and Hard Tissue Alterations Around Immediate Implants With Customized Healing Abutment N/A
Not yet recruiting NCT05891990 - Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft In Cases With Labial Plate Dehiscence N/A
Not yet recruiting NCT05946954 - Immediate Implant Placement Using Immediate Dentoalveolar Restoration Versus Ice Cream Cone Technique With Labial Plate Dehiscence N/A
Completed NCT05020405 - The Effect of Simvastatin With Guided Bone Regeneration in Ridge Splitting and Simultaneously Implantation N/A
Recruiting NCT04489654 - Immediate Implant Using Socket Shield Technique With Xenogenic Bone Graft N/A
Not yet recruiting NCT05431998 - Evaluation of Autogenous Demineralized Tooth Graft Versus Autogenous Bone Graft During Immediate Implant Placement in the Esthetic Zone. N/A
Completed NCT04731545 - Buccal Bone Resorption in Immediate SLActive Implant Placement Thin vs. Thick Buccal Bone N/A
Completed NCT05878392 - Immediate Implant With Different Filling Materials N/A