Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID04741607

Alveolar Ridge Preservation With Immediate or Late Implant Placement: a Multicenter Randomized Controlled Trial

Led by University Ghent · Updated on 2024-02-02

60

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of immediate versus delayed implant placement in patients needing a single implant in the front upper jaw (premaxilla). This multicenter randomized controlled trial involves 60 patients across six centers, aiming to compare the need for soft tissue grafting after alveolar ridge preservation between these two approaches. The trial also collects data on hard and soft tissue changes, clinical outcomes, aesthetics, and patient and clinician feedback over several years. Participants undergo digital planning and have a tooth-supported surgical guide made before tooth extraction. In the control group, ridge preservation is done after tooth extraction, followed by implant placement four months later. In the test group, the implant is placed immediately after extraction and ridge preservation is done by filling the gap around the implant. Both groups receive a provisional crown on the day of implant surgery, replaced with a permanent one three months later. Soft tissue grafting is assessed and possibly performed six months after extraction based on specific clinical criteria. During the study, participants receive preoperative antibiotics and anti-inflammatory medications, and detailed assessments including CBCT scans, clinical photos, and 3D digital models are used to evaluate tissue changes and implant outcomes. A panel of clinicians reviews the need for soft tissue augmentation at six months. Follow-up visits and evaluations continue up to five years to measure implant survival, tissue changes, aesthetic outcomes, and complications. The trial includes careful monitoring and blinded assessment to ensure unbiased results.

CONDITIONS

Brief Title

Immediate Versus Late Placement

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old
  • Good oral hygiene with full-mouth plaque score ≤ 25%
  • Presence of a single-rooted tooth in the anterior maxilla (front upper jaw) needing extraction with at least one neighboring tooth
  • At least 3 mm bone available at the apical or palatal side of the alveolus to ensure implant stability
  • Intact or nearly intact buccal bone wall at extraction (no more than 3 mm missing)
Not Eligible

You will not qualify if you...

  • Systemic diseases
  • Smoking
  • Untreated periodontal disease
  • Untreated caries lesions

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Ridge Preservation and Implant Placement

Duration - Initial procedure and up to 4 months healing for delayed implant placement

Participants receive ridge preservation with either immediate implant placement following tooth extraction or delayed implant placement after a healing period. This includes taking antibiotics and anti-inflammatory medication before the procedure, tooth extraction without flap raising, implant placement according to their group, grafting with collagen-enriched DBBM, and provisional crown placement.

1 procedure visit and 1 implant placement visit for delayed implant group; 1 procedure visit for immediate implant group

Soft Tissue Augmentation Assessment

Duration - At 6 months post-procedure

At 6 months, clinicians assess the need for soft tissue augmentation based on clinical pictures, CBCT scans, and 3D models. Soft tissue augmentation is offered if the majority of clinicians agree it is necessary.

1 assessment visit

Soft Tissue Augmentation Procedure and Follow-up

Duration - Procedure plus 3 months follow-up

Participants requiring soft tissue augmentation undergo a connective tissue graft procedure with follow-up care including suture removal after 1 week and replacement of the provisional crown by a permanent crown 3 months later.

1 augmentation procedure visit, 1 suture removal visit, and follow-up visits for crown replacement

Trial Site Locations

Total: 2 locations

1

Ghent University

Ghent, Oost-Vlaanderen, Belgium, 9000

Actively Recruiting

2

UCL St Luc

Liège, Belgium

Actively Recruiting

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Research Team

J

Jan Cosyn, Professor

L

Lorenz Seyssens, Phd candidate

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Changes of the alveolar ridge dimension and gingival recession associated with implant position and tissue phenotype with immediate implant placement: A randomised controlled clinical trial.

Nurit Bittner, Ulrike Schulze-Späte, Cleber Silva...

https://pubmed.ncbi.nlm.nih.gov/31781700

Soft tissue preservation and pink aesthetics around single immediate implant restorations: a 1-year prospective study.

Jan Cosyn, Hugo De Bruyn, Roberto Cleymaet

https://pubmed.ncbi.nlm.nih.gov/22376232

Minimally Invasive Single Implant Treatment (M.I.S.I.T.) based on ridge preservation and contour augmentation in patients with a high aesthetic risk profile: one-year results.

Jan Cosyn, Louis Pollaris, Filip Van der Linden...

https://pubmed.ncbi.nlm.nih.gov/25728590

Facial gingival tissue stability following immediate placement and provisionalization of maxillary anterior single implants: a 2- to 8-year follow-up.

Joseph Y K Kan, Kitichai Rungcharassaeng, Jamie L Lozada...

https://pubmed.ncbi.nlm.nih.gov/21365054

Clinical and Aesthetic Outcome with Post-Extractive Implants with or without Soft Tissue Augmentation: A 2-Year Randomized Clinical Trial.

Marco Migliorati, Leonardo Amorfini, Alessio Signori...

https://pubmed.ncbi.nlm.nih.gov/24373419

The effect of placing a bone replacement graft in the gap at immediately placed implants: a randomized clinical trial.

Mariano Sanz, Jan Lindhe, Jaime Alcaraz...

https://pubmed.ncbi.nlm.nih.gov/27273298

Effects of connective tissue grafting on the facial gingival level following single immediate implant placement and provisionalization in the esthetic zone: a 1-year randomized controlled prospective study.

Shuji Yoshino, Joseph Y K Kan, Kitichai Rungcharassaeng...

https://pubmed.ncbi.nlm.nih.gov/24683571