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

NCT07041294 | Active Not Recruiting

• 1 other identifier: NR430PROT
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Deantal implant; Immediate implant; Post-extraction implant; Wide diameter implant; Follow-up

Outcome Measures

Primary Outcomes (3)

• Number of failed crowns (not placed or remade due to implant/prosthetic failure)

  whether it will not be possible to place the crown because of implant failure or secondary to implant failure, or crown that has to be remade for any reason.

  From implant placement to 5 years after loading.

• Number of failed implants (implant mobility, infection, or mechanical complications)

  Implant failure is defined as implant mobility and/or any infection dictating implant removal, and or/any mechanical problems rendering the implant unusable. The stability of each individual implant will be measured by the independent and blinded outcome assessor manually with a reverse torque of 20 Ncm at abutment connection and at delivery of the definitive crown, or by assessing the stability of the crown, using the handles of two metallic instruments, at 1 and 5 years after loading.

  From implant placement to 5 years post loading.

• Biological and biomechanical complications

  Biological and biomechanical complications will be recorded and reported by study group. Examples of biological complications are: fistula, peri-implantitis. Examples of biomechanical complications are fracture of the metal screws, loosening of the crown, fracture of ceramic.

  From implant placement to 5 years after loading.

Secondary Outcomes (3)

• Peri-implant marginal bone level changes

  From implant placement to 5 years after loading.

• Aesthetic evaluation

  From implant placement to 5 years after loading.

• Patient satisfaction

  From implant placement to 5 years after loading.

Study Arms (2)

7 mm Diameter Implant

EXPERIMENTAL

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

Device: 7 mm Diameter Dental Implant

5 mm Diameter Implant

ACTIVE COMPARATOR

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

Device: 5 mm Diameter Dental Implant

Interventions

7 mm Diameter Dental Implant DEVICE

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

7 mm Diameter Implant

5 mm Diameter Dental Implant DEVICE

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

5 mm Diameter Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marco Esposito: lead

Study Sites (1)

Nobel dental clinic

Tirana, Albania

Location

Related Publications (1)

• Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.

  PMID: 16307569 RESULT

Study Officials

• Marco Esposito, Dentistry

  IRCCS San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milan, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician performing the data analysis is masked to the treatment allocation in order to prevent bias during statistical evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 27, 2025
• Study Start: October 1, 2021
• Primary Completion: May 15, 2025
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

AL (1)