- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07177521
- Original Trial
Primary Stability and Peri-implant Outcomes of Short Implants in Post-extraction Single-tooth Sites
Primary Stability and Peri-implant Outcomes of Short Implants in Post-extraction Single-tooth Sites: a Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Giuseppe D'Albis, Dr
- Phone Number: +393495103642
- Email: giuseppe.dalbis@uniba.it
Study Contact Backup
- Name: Saverio Capodiferro
- Email: saverio.capodiferro@uniba.it
Study Locations
-
-
-
Bari, Italy, 70021
- Recruiting
- University of Bari Aldo Moro
-
Contact:
- Giuseppe D'Albis
- Phone Number: +393495103642
- Email: dalbisgiuseppe@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Socket grafting with a fully resorbable synthetic biomaterial (β-tricalcium phosphate + calcium sulfate).
|
Two widely used approaches include:
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. |
|
Active Comparator: Group 2
Socket grafting with a xenograft and a custom Sealing Socket Abutment with a concave emergence profile.
|
Two widely used approaches include:
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary stability
Time Frame: 1 month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Indices
Time Frame: 12 months
|
To assess peri-implant health indices (PD)
|
12 months
|
|
Clinical Indices
Time Frame: 12 month
|
To assess peri-implant health indices (BoP)
|
12 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Giuseppe D'Albis, Dr, University of Bari Aldo Moro
- Study Chair: Saverio Capodiferro, Prof, University of Bari Aldo Moro
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Post-extraction-implants
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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