NCT05157009

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

2.2 years

First QC Date

November 8, 2021

Last Update Submit

April 24, 2023

Conditions

Tooth LossBone Loss, AlveolarDental DiseasesDental Trauma

Keywords

immediate dental implantdental implantbone regenerationperi-implantitis

Outcome Measures

Primary Outcomes (2)

  • Evaluate implant placement feasibility & success rate at 12 months

    evaluate implant success following Karoussis et al. success criteria

    12 months

  • 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 Outcomes (3)

  • Implant transparency: clinical presence or absence

    12 months

  • Number of participants with >0.2mm of marginal bone levels

    12 months

  • Band of keratinized tissue: clinical presence or absence

    12 months

Study Arms (2)

Immediate implant placement without reconstruction

OTHER

Immediate implant placement after tooth extraction

Procedure: implant placement

Immediate implant placement with reconstruction

OTHER

Immediate implant placement and simultaneous bone reconstruction after tooth extraction

Procedure: implant placement

Interventions

implant placementPROCEDURE

autogenous bone reconstruction of damaged socket \& simultaneous implant placement

Also known as: bone reconstruction
Immediate implant placement with reconstructionImmediate implant placement without reconstruction

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FV, DDS,Corp

San Gabriel, California, 91776, United States

Location

MeSH Terms

Conditions

Tooth LossAlveolar Bone LossStomatognathic DiseasesPeri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesTooth DiseasesBone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal Atrophy

Study Officials

  • Verdugo, PhD

    Verdugo, Fernando, DDS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2021

First Posted

December 14, 2021

Study Start

October 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations

US(1)