State of the Art Immediate Implant Placement in the Premaxilla
ConditionBone Resorption
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorUniversity Ghent
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Pregnancy (will be explicitly asked)
Systemic diseases
Smoking; suppuration
> 1 mm gingival asymmetry between the failing teeth and contralateral teeth
Trial design
Design model
Single group
Treatments tested in this trial
Immediate implant placement
Procedure/SurgeryImmediate 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Immediate implant placementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Buccal bone thickness -1 (mm)
Buccal bone thickness at 1 mm below the implant shoulder at one-year follow-up as assessed on a three-dimensional radiograph.
Time frame
moment of enrollment and 1-yearSecondary outcomes
1
Patient reported outcomes
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).
Time frame
one week after surgery2
Pink Esthetic Score
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).
Time frame
enrollment, 1-year, 5-year3
Buccal bone thickness -3 and -5 (mm)
Buccal bone thickness at 3mm and 5mm below the implant shoulder at one-year follow-up as assessed on a three-dimensional radiograph.
Time frame
enrollment and 1-year4
Marginal bone loss
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.
Time frame
1-, 5-yearSponsors and contacts
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Source ClinicalTrials.gov