Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
Healthy Volunteers
ID07080710

A Clinical Study on Immediate Implant Placement in the Premaxilla With Flapless Guided Surgery, Hard and Soft Tissue Augmentation and Immediate Provisionalization

Led by University Ghent · Updated on 2025-11-18

50

Participants Needed

2

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate how well immediate implant placement works in the front upper jaw (premaxilla) using flapless guided surgery along with hard and soft tissue augmentation and immediate provisional crowns. The study focuses on measuring bone thickness and examining safety and esthetic results over time. It will compare outcomes between patients with intact bone sockets and those with damaged sockets. Participants will receive a dental implant and a temporary crown on the same day as tooth extraction through a guided, flapless surgical procedure. Bone and soft tissue grafts will be used to support healing. Depending on the condition of the bone socket, different grafting techniques and materials, including collagen membranes and bone mixtures, may be applied. Antibiotics and anti-inflammatory medications are given for 4 days post-surgery. Follow-up visits occur at 1 week, 3 months, 1 year, and 5 years. During the study, participants will undergo X-rays, digital scans, photos, and questionnaires to assess bone and soft tissue changes, pain, healing, esthetic satisfaction, and peri-implant health. The main measurement is buccal bone thickness one year after implant placement. Additional assessments include marginal bone loss and soft tissue changes at one and five years. The overall participation may last up to five years with multiple evaluations to monitor outcomes and safety.

CONDITIONS

Brief Title

State of the Art Immediate Implant Placement in the Premaxilla

Who Can Participate

Age: 20Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 20 years old
  • Good oral hygiene with full-mouth plaque score 25% or less
  • One or more upper front teeth (incisors, cuspids) or premolars needing extraction with at least one neighboring tooth present
  • At least 3 mm bone available at the apical or palatal side of the socket as seen on 3D radiograph
  • Written informed consent
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Presence of systemic diseases
  • Smoking or suppuration
  • Gingival asymmetry greater than 1 mm between failing and opposite teeth
  • Failing teeth outside bone envelope on 3D radiograph
  • Untreated periodontal disease or untreated tooth decay

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 1 week

Participants undergo flapless guided surgery for immediate implant placement with socket grafting and soft tissue augmentation. Antibiotics and anti-inflammatory medication are taken before and after surgery. A provisional implant crown is placed 2 days after surgery, followed by an intra-oral radiograph. Sutures are removed 1 week after surgery during a study-specific evaluation including pain assessment.

1 surgery visit, 1 visit 2 days later for provisional crown placement, and 1 visit 1 week after surgery

Post-operative Follow-up

Duration - 3 months

Participants continue post-operative care including antibiotics, anti-inflammatory medication, and mouth rinse. An intra-oral radiograph is taken 3 months after implant installation to assess osseointegration. If successful, participants are referred to their general dentist for permanent crown fabrication.

1 visit at 3 months (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants' esthetic satisfaction, buccal bone thickness, marginal bone loss, peri-implant health, and soft tissue changes are assessed at 1 year and 5 years after implant placement. Assessments include CBCT scans, intra-oral radiographs, clinical pictures, and digital impressions to monitor the implant and surrounding tissues over time.

Visits at 1 year and 5 years (in-person)

Trial Site Locations

Total: 2 locations

1

Ghent University

Ghent, East Flanders, Belgium, 9000

Actively Recruiting

2

Bv Dr. Cosyn

Zottegem, East Flanders, Belgium, 9620

Actively Recruiting

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Research Team

V

Véronique Christiaens, Phd

J

Jan Cosyn, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Correction of Buccal Dehiscence During Immediate Implant Placement Using the Flapless Technique: A Tomographic Evaluation.

Jamal Hassan Assaf, Débora do Canto Assaf, Raquel Pippi Antoniazzi...

https://pubmed.ncbi.nlm.nih.gov/27620655

Esthetic Outcome of Implants Placed in Fresh Extraction Sockets by Clinicians with or without Experience: A Medium-Term Retrospective Evaluation.

Antonio Barone, Paolo Toti, Simone Marconcini...

https://pubmed.ncbi.nlm.nih.gov/27861667