Comparing 7 mm and 5 mm Implants Placed Immediately After Molar Extraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2029-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Partial Edentulism in the Maxilla or in the Mandible Immediate Implant Placement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The statistician performing the data analysis is masked to the treatment allocation in order to prevent bias during statistical evaluation.

Study Groups

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7 mm Diameter Implant

Participants receive a 7 mm diameter implant placed immediately after molar extraction.

Group Type EXPERIMENTAL

7 mm Diameter Dental Implant

Intervention Type DEVICE

To evaluate immediate post-extraction implants with different diameters (7 vs. 5 mm)

5 mm Diameter Implant

Participants receive a 5 mm diameter implant placed immediately after molar extraction.

Group Type ACTIVE_COMPARATOR

5 mm Diameter Dental Implant

Intervention Type DEVICE

To evaluate immediate post-extraction implants with different diameters (5 vs. 7 mm)

Interventions

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7 mm Diameter Dental Implant

To evaluate immediate post-extraction implants with different diameters (7 vs. 5 mm)

Intervention Type DEVICE

5 mm Diameter Dental Implant

To evaluate immediate post-extraction implants with different diameters (5 vs. 7 mm)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* at least 18 years old
* able to sign an informed consent form
* requiring at least one immediate post-extractive implant in first and/or second molar sites
* sufficient bone to allow placement of an immediate implant at least 7 mm in length and 7 mm in diameter

Exclusion Criteria

* general contraindications to implant surgery
* immunosuppressed or immunocompromised
* irradiation in the head or neck area
* uncontrolled diabetes
* pregnancy or lactation
* untreated periodontitis
* poor oral hygiene and motivation
* addiction to alcohol or drugs
* psychiatric disorders
* unrealistic expectations
* acute infection (abscess) in the site intended for implant placement
* necessity to lift the maxillary sinus epithelium
* unable to commit to 5-year follow-up post-loading
* under treatment or had previous treatment with intravenous amino-bisphosphonates
* lack of bony wall completely surrounding the future implant
* participation in other studies interfering with present protocol.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No