Osseointegration Failure of Dental Implant Clinical Trial
Official title:
Bone Remodelling Around Implants With Different Macro-design Placed in Post Extraction Sockets: A CBCT Randomized Controlled Clinical Trial.
Verified date | January 2023 |
Source | University of Bari |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Several recent systematic reviews have highlighted how the macrodesign of dental implants can influence stress distribution and biomechanical and biological behavior in implants immediately inserted in post-extraction sites. Finite element analyzes have confirmed the benefit of the inclination of the implant threads in reducing implant displacement in post-extraction sites, increasing primary stability, and decreasing stress in contact with the trabecular bone. Other comparative studies have shown that the design of the threads of the implant does not affect the distribution of stress in the surrounding bone. In view of the need to evaluate the influence of implant macrodesign in the case of implants inserted in post-extraction alveoli, this study will examine the clinical results of two different types of implants with different macrodesigns, with the aim of providing scientific evidence in this regard. The present study will investigate through a randomized controlled trial the effect of thread macrodesign of X-space implants on primary stability and osseointegration when inserted in post-extraction sites, as compared to cylindric 2P implants.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 1, 2022 |
Est. primary completion date | June 2, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | Inclusion Criteria: - Absence of systemic or local diseases that could compromise implant or prosthetic therapy - Good periodontal health, assessed by periodontal indices - Presence of premolar / canine / incisor teeth and with extraction indications and with the presence of two adjacent natural teeth. - Absence of probing greater than 4mm in the vestibular wall of the crestal bone Exclusion Criteria: - CT scan performed in the last 5 years - Active periodontal diseases - Heavy smokers (more than 20 cigarettes per day) - Consumers of high alcohol levels - Therapy with corticosteroids, immunosuppressive therapies, chemotherapy, radiotherapy, pregnancy - Lack of collaboration for continuous post-intervention re-evaluations |
Country | Name | City | State |
---|---|---|---|
Italy | Aldo Moro University | Bari |
Lead Sponsor | Collaborator |
---|---|
University of Bari |
Italy,
Cali M, Zanetti EM, Oliveri SM, Asero R, Ciaramella S, Martorelli M, Bignardi C. Influence of thread shape and inclination on the biomechanical behaviour of plateau implant systems. Dent Mater. 2018 Mar;34(3):460-469. doi: 10.1016/j.dental.2018.01.012. Epub 2018 Feb 1. — View Citation
Grassi FR, Grassi R, Rapone B, Alemanno G, Balena A, Kalemaj Z. Dimensional changes of buccal bone plate in immediate implants inserted through open flap, open flap and bone grafting and flapless techniques: A cone-beam computed tomography randomized controlled clinical trial. Clin Oral Implants Res. 2019 Dec;30(12):1155-1164. doi: 10.1111/clr.13528. Epub 2019 Sep 11. — View Citation
Lima de Andrade C, Carvalho MA, Bordin D, da Silva WJ, Del Bel Cury AA, Sotto-Maior BS. Biomechanical Behavior of the Dental Implant Macrodesign. Int J Oral Maxillofac Implants. 2017 Mar/Apr;32(2):264-270. doi: 10.11607/jomi.4797. — View Citation
Scarano A, Assenza B, Inchingolo F, Mastrangelo F, Lorusso F. New Implant Design with Midcrestal and Apical Wing Thread for Increased Implant Stability in Single Postextraction Maxillary Implant. Case Rep Dent. 2019 Sep 5;2019:9529248. doi: 10.1155/2019/9 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Complications | Complications during and after implant insertion assessed by patient referral and during clinical checks. | During the entire follow-up period- up to 6 months. | |
Primary | Buccal bone dimensional changes | Measurements of buccal bone dimensional changes assessed through a series of linear measurements on two cone-beam (immediately after implant insertion and after 6 months). Measurements will be calibrated using the implant as a reference and will be performed at the marginal bone level, at the central spire level and at the apex level. Outcome will be expressed in mm. | 6 months | |
Primary | Implant failure | Dental implant loss after insertion. Outcome will be assessed during follow-up checks and confirmed through clinical signs of loss (implant mobility) and intraoral radiograph. | 6 months | |
Secondary | Primary stability | Measurement of primary stability immediately after implant insertion through Osttell Mentor and expressed as implant stability quotient (ISQ) | immediately after implant insertion |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06099834 -
Evaluation of Osseointegration Process of Dental Implants
|
N/A | |
Active, not recruiting |
NCT06034067 -
Osseodensification Versus Conventional Drilling for Implant Site Preparation
|
N/A | |
Completed |
NCT06274216 -
The Effect of Vitamin D Supplementation on Dental Implant Osseointegration: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04061694 -
Immediate Loading and Fully Guided Surgery: Single Implants
|
N/A | |
Recruiting |
NCT06453330 -
A Randomised Control Clinical Trial Investigating the Effect of H-PRF on Implant Stability and Marginal Bone Levels
|
N/A | |
Recruiting |
NCT05766878 -
The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics
|
N/A | |
Completed |
NCT05507047 -
Emdogain Implementation With Transcrestal Sinus Lifting and Dental Implant Placement
|
Phase 4 | |
Completed |
NCT06452251 -
Vitamin-D Insufficiency and Implants
|
||
Completed |
NCT04879446 -
The Effect of Growth Factor on Implant Osseointegration
|
N/A |