X-space Implants in Post-extraction Sites.

NCT04492111 | Completed DMC

• 1 other identifier: UniBari
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Missing Tooth; Osseointegration Failure of Dental Implant

Keywords

primary stability; dental implant; post-extraction dental implant; dental implant macrodesign; implant failure

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Primary stability

  immediately after implant insertion

Other Outcomes (1)

• Complications

  During the entire follow-up period- up to 6 months.

Study Arms (2)

X-space group

EXPERIMENTAL

Each patient of the experimental group will receive one X-space implant.

Procedure: post-extraction dental implant

2P group

ACTIVE COMPARATOR

Each patient of the control group will receive one 2P implant. Bone System Cylindric implants. Surface Ecotek.

Procedure: post-extraction dental implant

Interventions

post-extraction dental implant PROCEDURE

Insertion of a dental implant immediately after tooth extraction.

2P group; X-space group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Aldo Moro University

Bari, 70121, Italy

Location

Related Publications (4)

• 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.

  PMID: 28291847 BACKGROUND

• 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.

  PMID: 29395470 BACKGROUND

• 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.

  PMID: 31461183 BACKGROUND

• 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: 10.1155/2019/9529248. eCollection 2019.

  PMID: 31583139 RESULT

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Felice Roberto Grassi, PhD

  University of Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patient not aware of the type of implant. Investigator of clinical conditions not aware of the type of implant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized clinical trial of parallel design with a 1:1 allocation ratio

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 30, 2020
• Study Start: September 2, 2020
• Primary Completion: June 2, 2022
• Study Completion: October 1, 2022
• Last Updated: January 5, 2023

Record last verified: 2023-01

Locations

IT (1)