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NCT Number: NCT07080710

State of the Art Immediate Implant Placement in the Premaxilla

The goal of this clinical study is to learn how well immediate implant placement works in the front upper jaw (premaxilla) when using flapless guided surgery, hard and soft tissue augmentation, and immediate provisional crowns. It will also learn about the safety and esthetic results of this treatment approach.

The main questions it aims to answer are:

Primary:

How much buccal bone thickness remains one year after implant placement 1mm below the implant shoulder?

Secondary:

* How do patients rate pain, healing, and esthetics after treatment? * Are there any complications over the course of five years? * How much buccal bone thickness remains one year after implant placement 3mm and 5mm below the implant shoulder? * Marginal bone loss at one-year and five-year follow-up? * Peri-implant health at one-year and five-year follow-up? * Soft tissue changes at one-year and five-year follow-up?

Researchers will compare treatment results in patients with intact bone sockets to those with damaged (non-intact) sockets.

Participants will:

* Receive a dental implant and temporary crown on the same day as the tooth extraction * Undergo guided, flapless surgery with bone and soft tissue grafting * Take antibiotics and anti-inflammatories for 4 days after surgery * Visit the clinic at 1 week, 3 months, 1 year, and 5 years for follow-up exams * Have X-rays, digital scans, and photos taken to measure bone and soft tissue changes * Answer questions about pain and esthetic satisfaction

Recruiting

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University, Ghent, East Flanders, Belgium

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About this study

Preoperative three-dimensional radiograph and intra-oral digital impression:

Required to select eligible patients. All three-dimensional radiographs will be taken with lip retractors.

An intra-oral digital impression of the maxilla will also be taken. Designated software will be used to merge dicoms files (three-dimensional radiograph) and the STL file (intra-oral digital impression) to fabricate a surgical guide.

Surgery:

All surgeries will be performed by two implant surgeons . Patients start to take systemic antibiotics (Amoxicilline 1g) and anti-inflammatory medication (Ibuprofen 600 mg) 1h pre-operatively. Following local anesthesia and oral disinfection the failing tooth is extracted as atraumatically as possible and without raising a flap. Following wound debridement, a cutting implant is installed in an optimal 3D position using a surgical guide. Socket grafting is performed with collagen-enriched deproteinized bovine bone mineral to limit buccal bone resorption and to optimize soft tissue stability. Thereupon, a free gingival graft is harvested from the palatal mucosa in the premolar area and de-epithelialized to arrive at a connective tissue graft (CTG) between 1 mm and 2 mm thickness. Height and length are tailored to the dimensions of the site. Then, the CTG is sutured with two or three single sutures onto the buccal mucosa. Finally, a healing abutment is installed, which is replaced by a provisional implant crown 2 days later. Following provisional crown installation, an intra-oral radiograph is taken. This postoperative intra-oral radiograph is standard in clinical practice, also for patients who are not participating in the study.

When dealing with a shallow non-intact socket (buccal dehiscence < 3 mm = type IIa), the same technique is applied. When dealing with a dehiscence between 4 mm and 6 mm (type IIb), a collagen membrane is applied prior to socket grafting to separate the grafting material from the buccal mucosa. When dealing with a very deep dehiscence (> 6 mm = type IIc), a collagen membrane is also applied and a mixture of C-DBBM and autogenous bone chips (1:1 ratio) is used as grafting material.

Postoperative care:

Patients continue the intake of antibiotics (2 times per day) and anti-inflammatory medication (2 times per day) for 4 days and use a chlorhexidine mouth rinse during 1 week. Sutures are removed 1 week after surgery. At that time point the patient will be asked how many analgesics had been taken, and also the pain intensity will be rated on a numeric rating scale.

These are study-specific evaluations.

Three months after implant installation an intra-oral radiograph is taken to assess osseointegration. This intra-oral radiograph is standard in clinical practice, also for patients who are not participating in the study.

When the implant is successfully integrated, the patient is sent to the general dentist for fabrication of the permanent crown.

1-year registrations:

  • Patients' esthetic satisfaction will be assessed on the basis of a numeric rating scale.
  • A CBCT will be taken to assess buccal bone thickness at 1 mm, 3 mm and 5 mm below the implant shoulder.
  • An intra-oral radiograph is taken to assess marginal bone loss.
  • Peri-implant health as clinically assessed on the basis of probing depth, bleeding on probing and plaque.
  • Clinical pictures to assess the esthetic outcome of the soft tissues surrounding the crown.
  • An intra-oral digital impression will be taken of the upper jaw. The pre-op impression and the one-year impression will be superimposed in designated software to calculate soft tissue changes.

5-year registrations:

  • Patients' esthetic satisfaction will be assessed on the basis of a numeric rating scale.
  • An intra-oral radiograph is taken to assess marginal bone loss.
  • Peri-implant health as clinically assessed on the basis of probing depth, bleeding on probing and plaque.
  • Clinical pictures are taken to assess the esthetic outcome of the soft tissues surrounding the crown.
  • An intra-oral digital impression will be taken of the upper jaw. The pre-op impression and the five-year impression will be superimposed in designated software to calculate soft tissue changes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 20 years old
  • Good oral hygiene defined as full-mouth plaque score ≤ 25%
  • Presence of one or more incisors, cuspids or premolars in the maxilla that need to be extracted for any reason with at least one neighboring tooth present
  • At least 3 mm bone available at the apical or palatal aspect of the alveoli as assessed on a three-dimensional radiograph to ensure primary implant stability
  • Written informed consent.

Exclusion criteria

  • Pregnancy (will be explicitly asked)
  • Systemic diseases
  • Smoking; suppuration
  • > 1 mm gingival asymmetry between the failing teeth and contralateral teeth
  • Failing teeth outside the bone envelop as assessed on a three-dimensional radiograph
  • Untreated periodontal disease; untreated caries lesions.

Treatment and study plan

Immediate Implant Placement

Procedure

Immediate implant placement with socket grafting and soft tissue augmentation. In cases with a buccal dehiscence >3mm only this technique is applied. In cases with a buccal dehiscence between 4-6mm a collagen membrane is applied prior to socket grafting. In cases with a buccal dehiscence > 6 mm, a collagen membrane is also applied and a mixture of C-DBBM and autogenous bone chips (1:1 ratio) is used as grafting material.

Primary outcomes

  1. Buccal bone thickness -1 (mm)

    Time frame: moment of enrollment and 1-year

    Buccal bone thickness at 1 mm below the implant shoulder at one-year follow-up as assessed on a three-dimensional radiograph.

Secondary outcomes

  1. Patient reported outcomes

    Time frame: one week after surgery

    One week after surgery, patients will be asked how many analgesics have been taken. In addition, they will be asked to rate postoperative pain on a numeric rating scale (0-10).

  2. Pink Esthetic Score

    Time frame: enrollment, 1-year, 5-year

    Pink Esthetic Score (PES) is registered by a trained and blinded examiner using frontal and occlusal clinical pictures taken at 1 year and 5-year follow-up. The PES results in a score from 0 (worst esthetic outcome) to 14 (perfect esthetic outcome).

  3. Buccal bone thickness -3 and -5 (mm)

    Time frame: enrollment and 1-year

    Buccal bone thickness at 3mm and 5mm below the implant shoulder at one-year follow-up as assessed on a three-dimensional radiograph.

  4. Marginal bone loss

    Time frame: 1-, 5-year

    Changes in the distance from the implant-abutment interface to the first bone-to-implant contact (so-called marginal bone level) at the mesial and distal aspect of each implant as measured on 2D intra-oral radiographs.

  5. Peri-implant health

    Time frame: 1-, 5-year

    Peri-implant health is clinically assessed on the basis of probing depth, bleeding on probing and plaque.

  6. Soft tissue changes

    Time frame: enrollment, 1-year , 5-year

    An intra-oral digital impression will be taken of the upper jaw. The pre-op impression and the one-year impression will be superimposed in designated software to calculate soft tissue changes.

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Cosyn, PhD

CONTACT

[email protected]

09/332 40 18

Véronique Christiaens, Phd

CONTACT

[email protected]

09/332 40 17

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2032
First posted
Jul 23, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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