Immediate Implant Outcomes With and Without Bone Augmentation

Tooth Loss Clinical Trial

Official title:

Immediate Implants in Damaged Sockets With Simultaneous Bone Reconstruction vs. Immediate Implants in Intact Sockets and no Reconstruction

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05157009
• Other study ID #: VerdugoF
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Verdugo, Fernando, DDS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate immediate implant placement feasibility and esthetic outcomes in severely damaged sockets that received simultaneously bone reconstruction (cortical bone shield) and implant placement versus intact sockets that needed no reconstruction and had immediate implant placement.

Description:

The present clinical trial aims at demonstrating facial bone regeneration on sites that presented large buccal bone dehiscences & vertical bone loss and evaluate the feasibility of performing simultaneous bone augmentation and implant placement, comparing the outcomes with sites that had intact sockets that did not require reconstruction. A secondary objective was to evaluate pink esthetics and marginal bone levels at final follow-up.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• individuals 20 Years and older

• Patients requiring single implants to replace missing teeth to restore masticatory function and esthetics.

• ASA1 or ASA2 (American Society of Anesthesiologists)

• Healthy individuals with good oral hygiene and motivation

• No systemic uncontrolled diseases

• Not taking drugs known to modify bone metabolism

Exclusion Criteria:

• Individuals with untreated & generalized severe periodontitis

• Smokers (>5 cigarettes/day)

• Poor oral hygiene

• Diabetes (HbA1C >6.5% as cutoff value)

• Uncontrolled cardiovascular disease

• Poor overall health (ASA IV)

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone Loss, Alveolar
• Dental Diseases
• Dental Trauma
• Stomatognathic Diseases
• Tooth Loss

Intervention

Procedure:
• implant placement
autogenous bone reconstruction of damaged socket & simultaneous implant placement

Locations

Country	Name	City	State
United States	FV, DDS,Corp	San Gabriel	California

Sponsors (1)

Lead Sponsor	Collaborator
Verdugo, Fernando, DDS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate implant placement feasibility & success rate at 12 months	evaluate implant success following Karoussis et al. success criteria	12 months
Primary	Number of individuals with low pink esthetic outcomes as assessed by pink esthetic scores (PES)	pink esthetics scores (PES) as proposed by Belser et al. Values 0-10 were 10 is the best esthetic outcome.	12 months
Secondary	Implant transparency: clinical presence or absence	Visual evaluation of facial mucosal implant transparency at 12 months: positive or negative	12 months
Secondary	Number of participants with >0.2mm of marginal bone levels	evaluate radiographic marginal bone levels at 12 months with >0.2mm of bone loss	12 months
Secondary	Band of keratinized tissue: clinical presence or absence	evaluate the presence of facial keratinized tissue on the implant sites >2 or <2mm	12 months