NCT07456553

Brief Summary

This is a prospective study, in which there are involved four clinical cases of surgical extraction of impacted maxillary canines followed by immediate implant placement and immediate screw-retained temporary crown using a full-digital workflow that included performing a CBCT, an intraoral scan, AI-assisted segmentation, a virtual wax-up, and the design of a surgical guide and a 30° angled abutment. Then, the follow-up lasting two years is performed to verify the functional and esthetical outcomes. The patients included in this report are part of an ongoing clinical trial, and the complete data set will be published separately upon study completion. The aims is to present clinical outcomes and synthesize evidence comparing placing implant to avoid buccal augmentation using angles abutments versus performing guided bone regeneration (GBR) to allow ideal implant placement with straight abutments, and to evaluate the risk of abutment screw loosening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

March 2, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

ImplantologyProsthesisFixed Crown

Outcome Measures

Primary Outcomes (2)

  • ISQ

    Implant stability quotient. ( 0 - 100)

    At implant insertion and after 3 months

  • Periimplant chart

    Probing the implant in 6 site.

    3 month after implant insertion, 1 year, 2 years

Study Arms (1)

Patients with impacted tooth

EXPERIMENTAL

Patient with impacted Maxillary Canine.

Procedure: Implantology

Interventions

ImplantologyPROCEDURE

Following local anesthetic infiltration and a minimally invasive access, the atraumatic extraction of the impacted canine is performed, preserving the vestibular soft and bone tissues. The implant site is then prepared, and the implant is placed using the surgical guide, with the required insertion torque to achieve primary implant stability.

Patients with impacted tooth

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Refuse Orthodontic treatments
  • Patients had to be healthy according to System of the American Society of Anesthesiology (ASA) and aged 18 years or older
  • No general medical condition representing a contraindication to implant therapy
  • minimum 2 missing teeth in the maxilla or mandible from the canine to the second molar
  • No periodontal disease (periodontal probing depth \<4 mm) or treated periodontitis
  • Good oral hygiene (full mouth plaque index\<25%)
  • Adequate control of inflammation (full mouth bleeding on probing\<25%)

You may not qualify if:

  • smoking of more than 15 cigarettes a day
  • untreated periodontal disease
  • acute infections
  • keratinized mucosal tissue less than 2 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Giuseppe D'Albis

Bari, 70124, Italy

Location

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Francesco Colacicco

    University of Bari Aldo Moro

    PRINCIPAL INVESTIGATOR
  • Giuseppe D'Albis, Dr.

    University of Bari Aldo Moro

    PRINCIPAL INVESTIGATOR
  • Saverio Capodiferro, Prof. Dr.

    University of Bari Aldo Moro

    STUDY DIRECTOR
  • Massimo Corsalini, Prof. Dr.

    University of Bari Aldo Moro

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 6, 2026

Study Start

January 1, 2024

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations