Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID04367766

Management of the Fresh Extraction Socket in the Aesthetic Area: Comparing Alveolar Ridge Preservation, Immediate Implant Placement, and Delayed Implant Placement

Led by Centro Specialistico Odontoiatrico, Rome · Updated on 2023-12-12

60

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing three treatment methods for patients who need a single tooth removed from the front part of their mouth, including premolars. The study looks at immediate implant placement, alveolar ridge preservation followed by delayed implant placement, and spontaneous healing followed by delayed implant placement. The goal is to assess patient outcomes like discomfort, treatment costs, bone and soft tissue changes, and implant success over a period of up to five years. Participants are randomly assigned to one of three groups: immediate implant placement with bone substitute and soft tissue matrix along with immediate provisional prosthesis; alveolar ridge preservation using bone substitute and collagen matrix, followed by implant placement with possible bone and soft tissue augmentation after four months; or spontaneous healing with implant placement and possible augmentation after four months. All implants are placed prosthetically with specific materials and techniques. Throughout the study, patients will have clinical, radiographic, and volumetric assessments at baseline, 4 months after extraction, and at 1, 3, and 5 years after receiving the final prosthesis. These evaluations will be done by clinicians not involved in the surgeries and who are unaware of the treatment groups. The main outcome measured is the need for additional bone and soft tissue augmentation during implant placement, along with long-term implant health and patient satisfaction. Maintenance visits will continue after prosthesis delivery.

CONDITIONS

Brief Title

Management of the Fresh Extraction Socket in the Aesthetic Area

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Need for single tooth extraction in the front area of the mouth, including premolars
  • Smoking no more than 10 cigarettes per day
  • Good gum health with bleeding on probing less than 10% and plaque control less than 20%
  • No symptomatic infections like acute abscesses at the extraction site
  • Extraction sites with less than 30% bone loss on one or more walls
  • Sufficient quality and quantity of native bone to secure implant stability
Not Eligible

You will not qualify if you...

  • Underage or still growing patients
  • Autoimmune diseases, uncontrolled diabetes, or weakened immune system
  • Previous radiation treatment to head and neck for cancer
  • Pregnancy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Approximately 4 months for initial treatment and healing phases, with implant placement occurring after healing as applicable.

Participants undergo one of three treatment approaches after tooth extraction: immediate implant placement, alveolar ridge preservation followed by delayed implant placement after 4 months, or spontaneous healing followed by delayed implant placement after 4 months.

Several visits including the initial extraction, treatment visits, and implant placement visits over the 4-month healing period.

Follow-up

Duration - Up to 5 years after final prosthesis delivery

Participants have clinical, radiographic, aesthetic, and patient satisfaction assessments at the time of prosthesis delivery and at 1, 3, and 5 years after final prosthesis placement to monitor implant success and peri-implant health.

Visits at prosthesis delivery and follow-up visits at 1, 3, and 5 years post prosthesis.

Trial Site Locations

Total: 1 location

1

Centro Specialistico Odontoiatrico (CSO)

Roma, Italy

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Research Team

M

Marco Clementini, DDS, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology.

Maurizio S Tonetti, Ronald E Jung, Gustavo Avila-Ortiz...

https://pubmed.ncbi.nlm.nih.gov/31215112

The effect of immediate implant placement on alveolar ridge preservation compared to spontaneous healing after tooth extraction: Radiographic results of a randomized controlled clinical trial.

Marco Clementini, Agnese Agostinelli, Walter Castelluzzo...

https://pubmed.ncbi.nlm.nih.gov/31050359