NCT07177521

Brief Summary

The placement of short implants in post-extraction sockets is a valuable option when residual bone height is limited, minimizing morbidity and treatment time. The management of the peri-implant gap and soft tissues may influence primary stability, hard/soft tissue remodeling, and implant success.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Jan 2025Aug 2026

Study Start

First participant enrolled

January 10, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2026

Expected
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

September 8, 2025

Last Update Submit

January 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary stability

    To compare the primary stability (ISQ values at implant insertion) of short implants placed in post-extraction sockets using the two grafting protocols.

    1 month

Secondary Outcomes (2)

  • Clinical Indices

    12 months

  • Clinical Indices

    12 month

Study Arms (2)

Group 1

EXPERIMENTAL

Socket grafting with a fully resorbable synthetic biomaterial (β-tricalcium phosphate + calcium sulfate).

Procedure: Insertion of implants in post-extraction tooth

Group 2

ACTIVE COMPARATOR

Socket grafting with a xenograft and a custom Sealing Socket Abutment with a concave emergence profile.

Procedure: Insertion of implants in post-extraction tooth

Interventions

Two widely used approaches include: 1. Socket grafting with a fully resorbable synthetic biomaterial (β-tricalcium phosphate + calcium sulfate). 2. Socket grafting with a xenograft and a custom Sealing Socket Abutment (SSA) with a concave emergence profile. No randomized controlled trials have yet compared these protocols with integrated outcomes including resonance frequency analysis, peri-implant health indices, radiographic bone level changes, and digital intraoral scanning (IOS)-based morphometric analysis.

Group 1Group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years.
  • Single-tooth post-extraction sites requiring immediate implant placement in posterior regions (premolars/molars) or selected anterior sites.
  • Planned short implant (≤7-8 mm length, 3.5-5.0 mm diameter).
  • Adequate oral hygiene, no active periodontal disease.
  • Written informed consent.

You may not qualify if:

  • Heavy smoking (\>20 cigarettes/day).
  • Uncontrolled diabetes or systemic conditions affecting bone healing.
  • Current bisphosphonate/antiresorptive therapy.
  • Immunosuppression, pregnancy.
  • Poor oral hygiene or acute infection at site.
  • Severe bone dehiscence preventing primary stability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bari Aldo Moro

Bari, 70021, Italy

RECRUITING

MeSH Terms

Conditions

Jaw, EdentulousTooth LossMouth, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth DiseasesTooth DiseasesPeriodontal Diseases

Study Officials

  • Giuseppe D'Albis, Dr

    University of Bari Aldo Moro

    PRINCIPAL INVESTIGATOR
  • Saverio Capodiferro, Prof

    University of Bari Aldo Moro

    STUDY CHAIR

Central Study Contacts

Giuseppe D'Albis, Dr

CONTACT

Saverio Capodiferro

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2025

First Posted

September 17, 2025

Study Start

January 10, 2025

Primary Completion

June 1, 2026

Study Completion (Estimated)

August 10, 2026

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations