Marginal Bone Loss in Single Implant Restaurations With Different Methods

• Sponsor: Universidad de León (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05301400
• Collaborator: (none)
• Enrollment: 59
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 9.9
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

The investigator is going to measure the marginal bone loss in single implant restaurations with three different methods: direct overcast, milled cad/cam direct to implant restauration and milled cad/cam implant restauration using an transepithelial pilar

Condition or Disease	Intervention/Treatment	Phase
Bone Loss	Device: Bti Unit	N/A

Detailed Description

The investigator has chosen a statistically significant sample (compared with other similar studies) to analize the bone marginal loss in different types of restauration with single dental implants

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Marginal Bone Loss in Single Implant Restaurations With Three Different Methods
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Overcast implant single restauration	Device: Bti Unit; Comparison with or without the device
Active Comparator: Cad/cam direct implant restauration	Device: Bti Unit; Comparison with or without the device
Active Comparator: Cad/cam implant restauration with transepithelial pilar	Device: Bti Unit; Comparison with or without the device

Outcome Measures

Primary Outcome Measures

1. Rate of marginal loss in single dental implants [6 months]

   To evaluate the vertical loss of bone in milimiters around the implant

Secondary Outcome Measures

1. Number of Implants with Prosthetic complications [6 months]

   The investigator is going to analyze if there is porcelain chipping (yes or not) and screw loosening (yes or not)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• patients with single implants restaurations treated in Leon University

Exclusion Criteria:

• pregnant

• mayor heath issues

• patients who do not agree to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad de Leon	León	Leon	Spain	24071

Sponsors and Collaborators

• Universidad de León

Investigators

• Study Director: Jesus Seco, Universidad de León

Study Documents (Full-Text)

• Study Protocol - Mar 24, 2022
• Informed Consent Form - Mar 24, 2022

More Information

Publications

None provided.

• Responsible Party: Patricia Truchuelo, Clinical Professor and principal investigator, Universidad de León
• ClinicalTrials.gov Identifier: NCT05301400
• Other Study ID Numbers: ULeon
• First Posted: Mar 29, 2022
• Last Update Posted: Mar 29, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Bone Diseases, Metabolic

Study Results

No Results Posted as of Mar 29, 2022