Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-31 @ 11:24 AM
Study NCT ID:
NCT07041294
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2025-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing 7 mm and 5 mm Implants Placed Immediately After Molar Extraction
Sponsor:
Marco Esposito
Organization:
Study Overview
Official Title:
7 mm Versus 5 mm Diameter Immediate Post-Extractive Implants in the Molar Region: A Multicentre Randomised Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical study aims to evaluate the performance and long-term outcomes of immediate dental implants placed in molar sites after tooth extraction. Eligible patients will receive one implant and a single crown in a posterior area (first or second molar). The study will compare implant and crown success over a five-year period, tracking complications, bone changes, aesthetics, and patient satisfaction. Participants must be at least 18 years old and have sufficient bone to allow immediate implant placement. This research will provide important data on the safety and reliability of immediate implants in posterior areas.
Detailed Description:
This multicentre randomised controlled trial aims to compare the clinical outcomes of 7 mm versus 5 mm diameter dental implants placed immediately after tooth extraction in the molar region. The goal is to assess whether wider diameter implants offer any advantages in terms of implant survival, complications, bone preservation, and patient satisfaction, when placed in fresh extraction sockets.
A total of 70 patients requiring molar tooth extraction and immediate implant placement will be enrolled across 7 centers. Each participant will receive either a 5 mm or a 7 mm diameter implant, allocated randomly. Standardised surgical and prosthetic protocols will be followed.
Follow-up visits will assess implant stability, radiographic bone changes, and clinical outcomes over time. Patient-reported outcomes and complications will also be recorded to compare the two groups. Results will be reported at 1 and 5 years after loading.
This study may help clinicians make evidence-based decisions when choosing the diameter of implants in molar regions, particularly in immediate post-extraction situations.
A total of 70 patients requiring molar tooth extraction and immediate implant placement will be enrolled across 7 centers. Each participant will receive either a 5 mm or a 7 mm diameter implant, allocated randomly. Standardised surgical and prosthetic protocols will be followed.
Follow-up visits will assess implant stability, radiographic bone changes, and clinical outcomes over time. Patient-reported outcomes and complications will also be recorded to compare the two groups. Results will be reported at 1 and 5 years after loading.
This study may help clinicians make evidence-based decisions when choosing the diameter of implants in molar regions, particularly in immediate post-extraction situations.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: